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A web-based program improves physical activity outcomes in a primary care angina population: randomized controlled trial.

R Devi, J Powell, S Singh

Journal of medical Internet research [16:e186] (2014)

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Angina affects more than 50 million people worldwide. Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population. An Internet-based version could offer a feasible alternative. Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina. We conducted a randomized controlled trial, recruiting those diagnosed with angina from general practitioners (GPs) in primary care to an intervention or control group. Intervention group participants were offered a 6-week Web-based rehabilitation program ("ActivateYourHeart"). The program was introduced during a face-to-face appointment and then delivered via the Internet (no further face-to-face contact). The program contained information about the secondary prevention of coronary heart disease (CHD) and set each user goals around physical activity, diet, managing emotions, and smoking. Performance against goals was reviewed throughout the program and goals were then reset/modified. Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room. Participants in the control group continued with GP treatment as usual, which consisted of being placed on a CHD register and attending an annual review. Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessments. The primary outcome measure was change in daily steps at 6 weeks, measured using an accelerometer. Secondary outcome measures were energy expenditure (EE), duration of sedentary activity (DSA), duration of moderate activity (DMA), weight, diastolic/systolic blood pressure, and body fat percentage. Self-assessed questionnaire outcomes included fat/fiber intake, anxiety/depression, self-efficacy, and quality of life (QOL). A total of 94 participants were recruited and randomized to the intervention (n=48) or the usual care (n=46) group; 84 and 73 participants completed the 6-week and 6-month follow-ups, respectively. The mean number of log-ins to the program was 18.68 (SD 13.13, range 1-51), an average of 3 log-ins per week per participant. Change in daily steps walked at the 6-week follow-up was +497 (SD 2171) in the intervention group and -861 (SD 2534) in the control group (95% CI 263-2451, P=.02). Significant intervention effects were observed at the 6-week follow-up in EE (+43.94 kcal, 95% CI 43.93-309.98, P=.01), DSA (-7.79 minutes, 95% CI -55.01 to -7.01, P=.01), DMA (+6.31 minutes, 95% CI 6.01-51.20, P=.01), weight (-0.56 kg, 95% CI -1.78 to -0.15, P=.02), self-efficacy (95% CI 0.30-4.79, P=.03), emotional QOL score (95% CI 0.01-0.54, P=.04), and angina frequency (95% CI 8.57-35.05, P=.002). Significant benefits in angina frequency (95% CI 1.89-29.41, P=.02) and social QOL score (95% CI 0.05-0.54, P=.02) were also observed at the 6-month follow-up. An Internet-based secondary prevention intervention could be offered to those with angina. A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness.

 


Development of a web-based and mobile app to support physical activity in individuals with rheumatoid arthritis: results from the second step of a co-design process.

Åsa Revenäs, Christina Opava, Cathrin Martin, Ingrid Demmelmaier, Christina Keller, Pernilla Åsenlöf

JMIR research protocols [4:e22] (2015)

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Long-term adherence to physical activity recommendations remains challenging for most individuals with rheumatoid arthritis (RA) despite evidence for its health benefits. The aim of this study was to provide basic data on system requirement specifications for a Web-based and mobile app to self-manage physical activity. More specifically, we explored the target user group, features of the future app, and correlations between the system requirements and the established behavior change techniques (BCTs). We used a participatory action research design. Qualitative data were collected using multiple methods in four workshops. Participants were 5 individuals with RA, a clinical physiotherapist, an officer from the Swedish Rheumatism Association, a Web designer, and 2 physiotherapy researchers. A taxonomy was used to determine the degree of correlation between the system requirements and established BCTs. Participants agreed that the future Web-based and mobile app should be based on two major components important for maintaining physical activity: (1) a calendar feature for goal setting, planning, and recording of physical activity performance and progress, and (2) a small community feature for positive feedback and support from peers. All system requirements correlated with established BCTs, which were coded as 24 different BCTs. To our knowledge, this study is the first to involve individuals with RA as co-designers, in collaboration with clinicians, researchers, and Web designers, to produce basic data to generate system requirement specifications for an eHealth service. The system requirements correlated to the BCTs, making specifications of content and future evaluation of effectiveness possible.

 


Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care.

Stephen Sutton, Susan Smith, James Jamison, Sue Boase, Dan Mason, A Toby Prevost, James Brimicombe, Melanie Sloan, Hazel Gilbert, Felix Naughton

BMC public health [13:324] (2013)

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Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker's mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone. The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking. This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness. ISRCTN56702353.

 


SafeTalk, a multicomponent, motivational interviewing-based, safer sex counseling program for people living with HIV/AIDS: a qualitative assessment of patients' views.

Carol Golin, Rebecca Davis, Sarahmona M Przybyla, Beth Fowler, Sharon Parker, Jo Anne Earp, E Byrd Quinlivan, Seth Kalichman, Shilpa Patel, Catherine Grodensky

AIDS patient care and STDs [24:237-45] (2010)

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With the continued transmission of HIV each year, novel approaches to HIV prevention are needed. Since 2003, the U.S. HIV prevention focus has shifted from primarily targeting HIV-negative at-risk persons to including safer sex programs for people already infected with HIV. At least 20-30% of people infected with HIV engage in risky sexual practices. Based on these data, policymakers have recommended that interventionists develop strategies to help HIV-infected people reduce their risky sexual behaviors. In the past, the few safer sex interventions that targeted HIV-infected people met with limited success because they basically adapted strategies previously used with HIV-uninfected individuals. In addition, often these adaptations did not address issues of serostatus disclosure, HIV stigma, or motivation to protect others from HIV. We had previously tested, in a demonstration project named the Start Talking About Risks (STAR) Program, a monthly three-session motivational interviewing (MI)-based intervention to help people living with HIV practice safer sex. In this study, we refined that program by enhancing its frequency and intensity and adding written and audio components to support the counseling. We theorized that an intervention such as MI, which is tailored to each individual's circumstances more than standardized prevention messages, would be more successful when supplemented with other components. We qualitatively assessed participants' perceptions, reactions, and preferences to the refined prevention with positives counseling program we called SafeTalk and learned that participants found the SafeTalk MI counseling and educational materials appealing, understandable, and relevant to their lives.

 


Self-Monitoring Utilization Patterns Among Individuals in an Incentivized Program for Healthy Behaviors.

Ju Young Kim, Nathan Wineinger, Michael Taitel, Jennifer Radin, Osayi Akinbosoye, Jenny Jiang, Nima Nikzad, Gregory Orr, Eric Topol, Steve Steinhubl

Journal of medical Internet research [18:e292] (2016)

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The advent of digital technology has enabled individuals to track meaningful biometric data about themselves. This novel capability has spurred nontraditional health care organizations to develop systems that aid users in managing their health. One of the most prolific systems is Walgreens Balance Rewards for healthy choices (BRhc) program, an incentivized, Web-based self-monitoring program. This study was performed to evaluate health data self-tracking characteristics of individuals enrolled in the Walgreens' BRhc program, including the impact of manual versus automatic data entries through a supported device or apps. We obtained activity tracking data from a total of 455,341 BRhc users during 2014. Upon identifying users with sufficient follow-up data, we explored temporal trends in user participation. Thirty-four percent of users quit participating after a single entry of an activity. Among users who tracked at least two activities on different dates, the median length of participating was 8 weeks, with an average of 5.8 activities entered per week. Furthermore, users who participated for at least twenty weeks (28.3% of users; 33,078/116,621) consistently entered 8 to 9 activities per week. The majority of users (77%; 243,774/315,744) recorded activities through manual data entry alone. However, individuals who entered activities automatically through supported devices or apps participated roughly four times longer than their manual activity-entering counterparts (average 20 and 5 weeks, respectively; P<.001). This study provides insights into the utilization patterns of individuals participating in an incentivized, Web-based self-monitoring program. Our results suggest automated health tracking could significantly improve long-term health engagement.

 


Development of a fully automated, web-based, tailored intervention promoting regular physical activity among insufficiently active adults with type 2 diabetes: integrating the I-change model, self-determination theory, and motivational interviewing components.

Michel Moreau, Marie-Pierre Gagnon, François Boudreau

JMIR research protocols [4:e25] (2015)

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Type 2 diabetes is a major challenge for Canadian public health authorities, and regular physical activity is a key factor in the management of this disease. Given that fewer than half of people with type 2 diabetes in Canada are sufficiently active to meet the recommendations, effective programs targeting the adoption of regular physical activity (PA) are in demand for this population. Many researchers argue that Web-based, tailored interventions targeting PA are a promising and effective avenue for sedentary populations like Canadians with type 2 diabetes, but few have described the detailed development of this kind of intervention. This paper aims to describe the systematic development of the Web-based, tailored intervention, Diabète en Forme, promoting regular aerobic PA among adult Canadian francophones with type 2 diabetes. This paper can be used as a reference for health professionals interested in developing similar interventions. We also explored the integration of theoretical components derived from the I-Change Model, Self-Determination Theory, and Motivational Interviewing, which is a potential path for enhancing the effectiveness of tailored interventions on PA adoption and maintenance. The intervention development was based on the program-planning model for tailored interventions of Kreuter et al. An additional step was added to the model to evaluate the intervention's usability prior to the implementation phase. An 8-week intervention was developed. The key components of the intervention include a self-monitoring tool for PA behavior, a weekly action planning tool, and eight tailored motivational sessions based on attitude, self-efficacy, intention, type of motivation, PA behavior, and other constructs and techniques. Usability evaluation, a step added to the program-planning model, helped to make several improvements to the intervention prior to the implementation phase. The intervention development cost was about CDN $59,700 and took approximately 54 full-time weeks. The intervention officially started on September 29, 2014. Out of 2300 potential participants targeted for the tailored intervention, approximately 530 people visited the website, 170 people completed the registration process, and 83 corresponded to the selection criteria and were enrolled in the intervention. Usability evaluation is an essential step in the development of a Web-based tailored intervention in order to make pre-implementation improvements. The effectiveness and relevance of the theoretical framework used for the intervention will be analyzed following the process and impact evaluation. Implications for future research are discussed.

 


Being controlled by normative influences: self-determination as a moderator of a normative feedback alcohol intervention.

Clayton Neighbors, Melissa Lewis, Rochelle Bergstrom, Mary Larimer

Health psychology : official journal of the Division of Health Psychology, American Psychological Association [25:571-9] (2006)

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The objectives of this research were to evaluate the efficacy of computer-delivered personalized normative feedback among heavy drinking college students and to evaluate controlled orientation as a moderator of intervention efficacy. Participants (N = 217) included primarily freshman and sophomore, heavy drinking students who were randomly assigned to receive or not to receive personalized normative feedback immediately following baseline assessment. Perceived norms, number of drinks per week, and alcohol-related problems were the main outcome measures. Controlled orientation was specified as a moderator. At 2-month follow-up, students who received normative feedback reported drinking fewer drinks per week than did students who did not receive feedback, and this reduction was mediated by changes in perceived norms. The intervention also reduced alcohol-related negative consequences among students who were higher in controlled orientation. These results provide further support for computer-delivered personalized normative feedback as an empirically supported brief intervention for heavy drinking college students, and they enhance the understanding of why and for whom normative feedback is effective.

 


Development and Validation of an Interactive Internet Platform for Older People: The Healthy Ageing Through Internet Counselling in the Elderly Study.

Susan Jongstra, Cathrien Beishuizen, Sandrine Andrieu, Mariagnese Barbera, Matthijs van Dorp, Bram van de Groep, Juliette Guillemont, Francesca Mangialasche, Tessa van Middelaar, Eric Moll van Charante, Hilkka Soininen, Miia Kivipelto, Edo Richard

Telemedicine journal and e-health : the official journal of the American Telemedicine Association (2016)

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A myriad of Web-based applications on self-management have been developed, but few focus on older people. In the face of global aging, older people form an important target population for cardiovascular prevention. This article describes the full development of an interactive Internet platform for older people, which was designed for the Healthy Ageing Through Internet Counselling in the Elderly (HATICE) study. We provide recommendations to design senior-friendly Web-based applications for a new approach to multicomponent cardiovascular prevention. The development of the platform followed five phases: (1) conceptual framework; (2) platform concept and functional design; (3) platform building (software and content); (4) testing and pilot study; and (5) final product. We performed a meta-analysis, reviewed guidelines for cardiovascular diseases, and consulted end users, experts, and software developers to create the platform concept and content. The software was built in iterative cycles. In the pilot study, 41 people aged ≥65 years used the platform for 8 weeks. Participants used the interactive features of the platform and appreciated the coach support. During all phases adjustments were made to incorporate all improvements from the previous phases. The final platform is a personal, secured, and interactive platform supported by a coach. When carefully designed, an interactive Internet platform is acceptable and feasible for use by older people with basic computer skills. To improve acceptability by older people, we recommend involving the end users in the process of development, to personalize the platform and to combine the application with human support. The interactive HATICE platform will be tested for efficacy in a multinational randomized controlled trial (ISRCTN48151589).

 


Randomized controlled trial testing an internet physical activity intervention for sedentary adults.

Lucas Carr, Shira Dunsiger, Beth Lewis, Joseph Ciccolo, Sheri Hartman, Beth Bock, Gregory Dominick, Bess Marcus

Health psychology : official journal of the Division of Health Psychology, American Psychological Association [32:328-36] (2013)

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Internet-based physical activity (PA) interventions have shown promise, although findings remain equivocal. We used formative research to enhance a previously demonstrated program (Step into Motion) with the goal of developing an Internet program poised for dissemination. We conducted focus groups to identify Internet features targeted to theoretical constructs (social cognitive theory) predictive of PA behavior and rated as "useful for increasing PA." We identified 5 theory-targeted Internet features as useful for increasing PA: (1) a PA tracking/logging calendar targeting self-monitoring and goal setting; (2) geographic mapping tools targeting perceived environment; (3) a discussion forum targeting social support; (4) exercise videos targeting observational learning; and (5) regular updates of peer PA progress targeting situation. We then tested the efficacy of the enhanced program (enhanced Internet, EI; N = 25) in relation to publicly available PA Websites (standard Internet, SI; N = 28) among 53 participants in a randomized controlled trial. The EI arm increased PA in relation to the SI arm at 3 months (18.4 to 186.0 min/wk vs. 20.9 to 57.3 min/wk; p = .03) but between-groups differences were not observed at 6 months (176.8 vs. 133.5 min/wk; p = .44). EI participants maintained PA from 3 to 6 months (186.0 to 176.8 min/wk), and the SI group increased PA (57.3 to 133.5 min/wk). The EI program was efficacious at improving PA levels in relation to publicly available Websites initially, but differences in PA levels were not maintained at 6 months. Future research should identify Internet features that promote long-term maintenance.

 


Efficacy and use of an internet-delivered computer-tailored lifestyle intervention, targeting saturated fat intake, physical activity and smoking cessation: a randomized controlled trial.

Anke Oenema, Johannes Brug, Arie Dijkstra, Inge de Weerdt, Hein De Vries

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine [35:125-35] (2008)

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Although experts claim that computer-tailored interventions provided over the Internet have great potential to promote health behavior change, few studies have tested the efficacy of computer-tailored lifestyle interventions online-delivered over the Internet. To evaluate the short-term (1 month) efficacy of an Internet-delivered, computer-tailored lifestyle intervention targeting saturated fat intake, physical activity (PA), and smoking cessation, and to evaluate exposure to the intervention. A pretest-posttest randomized controlled trial with an intervention group and a no intervention waiting list control group was conducted. Self-reported behavior and determinants were assessed at baseline and 1 month follow-up. Exposure to the intervention was monitored through server registrations. The data were analyzed using multiple linear and logistic regression analysis. The intervention resulted in a significantly lower self-reported saturated fat intake (b = -0.76, p < 0.01) and a higher likelihood of meeting the PA guidelines among respondents who were insufficiently active at baseline (OR = 1.34, 95%CI = 1.001-1.80). No significant intervention effects were found for self-reported smoking status. Of the participants, 81% actually visited the website. The Internet-delivered, computer-tailored lifestyle intervention was effective in reducing self-reported saturated fat intake and in increasing self-reported PA among participants who completed the study.

 



Development of StopAdvisor: A theory-based interactive internet-based smoking cessation intervention.

Susan Michie, Jamie Brown, Adam WA Geraghty, Sascha Miller, Lucy Yardley, Benjamin Gardner, Lion Shahab, Andy McEwen, John Stapleton, Robert West

Translational behavioral medicine [2:263-75] (2012)

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Reviews of internet-based behaviour-change interventions have shown that they can be effective but there is considerable heterogeneity and effect sizes are generally small. In order to advance science and technology in this area, it is essential to be able to build on principles and evidence of behaviour change in an incremental manner. We report the development of an interactive smoking cessation website, StopAdvisor, designed to be attractive and effective across the social spectrum. It was informed by a broad motivational theory (PRIME), empirical evidence, web-design expertise, and user-testing. The intervention was developed using an open-source web-development platform, 'LifeGuide', designed to facilitate optimisation and collaboration. We identified 19 theoretical propositions, 33 evidence- or theory-based behaviour change techniques, 26 web-design principles and nine principles from user-testing. These were synthesised to create the website, 'StopAdvisor' (see http://www.lifeguideonline.org/player/play/stopadvisordemonstration). The systematic and transparent application of theory, evidence, web-design expertise and user-testing within an open-source development platform can provide a basis for multi-phase optimisation contributing to an 'incremental technology' of behaviour change.

 



Development and preliminary evaluation of an internet-based healthy eating program: randomized controlled trial.

Katy Tapper, Gabriela Jiga-Boy, Gregory Maio, Geoffrey Haddock, Michael Lewis

Journal of medical Internet research [16:e231] (2014)

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The HealthValues Healthy Eating Programme is a standalone Internet-based intervention that employs a novel strategy for promoting behavior change (analyzing one's reasons for endorsing health values) alongside other psychological principles that have been shown to influence behavior. The program consists of phases targeting motivation (dietary feedback and advice, analyzing reasons for health values, thinking about health-related desires, and concerns), volition (implementation intentions with mental contrasting), and maintenance (reviewing tasks, weekly tips). The aim was to examine the effects of the program on consumption of fruit and vegetables, saturated fat, and added sugar over a 6-month period. A total of 82 females and 18 males were recruited using both online and print advertisements in the local community. They were allocated to an intervention or control group using a stratified block randomization protocol. The program was designed such that participants logged onto a website every week for 24 weeks and completed health-related measures. Those allocated to the intervention group also completed the intervention tasks at these sessions. Additionally, all participants attended laboratory sessions at baseline, 3 months, and 6 months. During these sessions, participants completed a food frequency questionnaire (FFQ, the Block Fat/Sugar/Fruit/Vegetable Screener, adapted for the UK), and researchers (blind to group allocation) measured their body mass index (BMI), waist-to-hip ratio (WHR), and heart rate variability (HRV). Data were analyzed using a series of ANOVA models. Per protocol analysis (n=92) showed a significant interaction for fruit and vegetable consumption (P=.048); the intervention group increased their intake between baseline and 6 months (3.7 to 4.1 cups) relative to the control group (3.6 to 3.4 cups). Results also showed overall reductions in saturated fat intake (20.2 to 15.6 g, P

 


Details of development of the resource for adults with asthma in the RAISIN (randomized trial of an asthma internet self-management intervention) study.

Deborah Morrison, Frances Mair, Rekha Chaudhuri, Marilyn McGee-Lennon, Mike Thomas, Neil Thomson, Lucy Yardley, Sally Wyke

BMC medical informatics and decision making [15:57] (2015)

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Around 300 million people worldwide have asthma and prevalence is increasing. Self-management can be effective in improving a range of outcomes and is cost effective, but is underutilised as a treatment strategy. Supporting optimum self-management using digital technology shows promise, but how best to do this is not clear. We aimed to develop an evidence based, theory informed, online resource to support self-management in adults with asthma, called 'Living well with Asthma', as part of the RAISIN (Randomized Trial of an Asthma Internet Self-Management Intervention) study. We developed Living well with Asthma in two phases. Phase 1: A low fidelity prototype (paper-based) version of the website was developed iteratively through input from a multidisciplinary expert panel, empirical evidence from the literature, and potential end users via focus groups (adults with asthma and practice nurses). Implementation and behaviour change theories informed this process. Phase 2: The paper-based designs were converted to a website through an iterative user centred process. Adults with asthma (n = 10) took part in think aloud studies, discussing the paper based version, then the web-based version. Participants considered contents, layout, and navigation. Development was agile using feedback from the think aloud sessions immediately to inform design and subsequent think aloud sessions. Think aloud transcripts were also thematically analysed, further informing resource development. The website asked users to aim to be symptom free. Key behaviours targeted to achieve this include: optimising medication use (including inhaler technique); attending primary care asthma reviews; using asthma action plans; increasing physical activity levels; and stopping smoking. The website had 11 sections, plus email reminders, which promoted these behaviours. Feedback on the contents of the resource was mainly positive with most changes focussing on clarification of language, order of pages and usability issues mainly relating to navigation difficulties. Our multifaceted approach to online intervention development underpinned by theory, using evidence from the literature, co-designed with end users and a multidisciplinary panel has resulted in a resource which end users find relevant to their needs and easy to use. Living well with Asthma is undergoing evaluation within a randomized controlled trial.

 



Guided, internet-based, rumination-focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high-ruminating young adults, along with an adjunct assessment of the feasibility of unguided i-RFCBT, in the REducing Stress and Preventing Depression trial (RESPOND): study protocol for a phase III randomised controlled trial.

L Cook, E Watkins

Trials [17:1] (2016)

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Depression is a global health challenge. Prevention is highlighted as a priority to reduce its prevalence. Although effective preventive interventions exist, the efficacy and coverage can be improved. One proposed means to increase efficacy is by using interventions to target specific risk factors, such as rumination. Rumination-focused CBT (RFCBT) was developed to specifically target depressive rumination and reduces acute depressive symptoms and relapse for patients with residual depression in a randomised controlled trial. Preliminary findings from a Dutch randomised prevention trial in 251 high-risk 15- to 22-year-old subjects selected with elevated worry and rumination found that both supported internet-RFBCT and group-delivered RFCBT equally reduced depressive symptoms and the onset of depressive cases over a period of 1 year, relative to the no-intervention control. A phase III randomised controlled trial following the Medical Research Council (MRC) Complex Interventions Framework will extend a Dutch trial to the United Kingdom, with the addition of diagnostic interviews, primarily to test whether guided internet-RFCBT reduces the onset of depression relative to a no-intervention control. High-risk young adults (aged 18 to 24 years), selected with elevated worry/rumination and recruited through university and internet advertisement, will be randomised to receive either guided internet-RFCBT, supported by clinical psychologists or mental health paraprofessionals, or a no-intervention control. As an adjunct arm, participants are also randomised to unguided internet-RFCBT self-help to provide an initial test of the feasibility and effect size of this intervention. While participants are also randomised to unguided internet-RFCBT, the trial was designed and powered as a phase III trial comparing guided internet-RFCBT versus a no-intervention control. In the comparison between these two arms, the primary outcomes are as follows: a) onset of major depressive episode over a 12-month period, assessed with a Structured Clinical Interview for Diagnosis at 3 months (post-intervention), 6 months and 15 months after randomisation. The following secondary outcomes will be recorded: the incidence of generalized anxiety disorder, symptoms of depression and anxiety, and levels of worry and rumination, measured at baseline and at the same follow-up intervals. In relation to the pilot investigation of unguided internet-RFCBT (the adjunct intervention arm), we will assess the feasibility and acceptability of the data-collection procedures, levels of attrition, effect size and acceptability of the unguided internet-RFCBT intervention. Widespread implementation is necessary for effective prevention, suggesting that the internet may be a valuable mode of delivery. Previous research suggests that guided internet-RFCBT reduces incidence rates relative to controls. We are also interested in developing and evaluating an unguided version to potentially increase the availability and reduce the costs. Current Controlled Trials ISRCTN12683436 . Date of registration: 27 October 2014.

 


A brief individualized computer-delivered sexual risk reduction intervention increases HIV/AIDS preventive behavior.

SM Kiene, WD Barta

The Journal of adolescent health : official publication of the Society for Adolescent Medicine [39:404-10] (2006)

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One objective of translational science is to identify elements of human immunodeficiency virus (HIV) risk-reduction interventions that have been shown to be effective and find new ways of delivering these interventions to the community to ensure that they reach the widest possible audience of at-risk individuals. The current study reports the development and evaluation of a computer-delivered, theory-based, individually tailored HIV risk-reduction intervention. This study evaluated the effectiveness of a custom computerized HIV/AIDS risk reduction intervention at increasing HIV/AIDS preventive behaviors in a randomized trial with 157 college students. The intervention content and delivery were based on the Information-Motivation-Behavioral Skills Model of Health Behavior Change and used Motivational Interviewing techniques. Participants completed a baseline assessment of HIV prevention information, motivation, behavioral skills and behavior, attended two brief computer-delivered intervention sessions, and completed a follow-up assessment. As compared to the control group (a nutrition education tutorial), participants who interacted with the computer-delivered HIV/AIDS risk reduction intervention exhibited a significant increase in risk reduction behavior. Specifically, participants reported a greater frequency of keeping condoms available and displayed greater condom-related knowledge at a four-week follow-up session; among sexually active participants, there was a significant increase in self-reported condom use. Delivery of brief individually tailored HIV/AIDS risk reduction interventions via computer may be an effective HIV/AIDS prevention approach for adolescents. More research is needed to further support the effectiveness of this type of intervention and determine the generalizability of these findings to economically and educationally disadvantaged adolescents.

 


Using the Behavior Change Technique Taxonomy v1 to conceptualize the clinical content of Breaking Free Online: a computer-assisted therapy program for substance use disorders.

Stephanie Dugdale, Jonathan Ward, Jan Hernen, Sarah Elison, Glyn Davies, Daniel Donkor

Substance abuse treatment, prevention, and policy [11:26] (2016)

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In recent years, research within the field of health psychology has made significant progress in terms of advancing and standardizing the science of developing, evaluating and reporting complex behavioral change interventions. A major part of this work has involved the development of an evidence-based Behavior Change Technique Taxonomy v1 (BCTTv1), as a means of describing the active components contained within such complex interventions. To date, however, this standardized approach derived from health psychology research has not been applied to the development of complex interventions for the treatment of substance use disorders (SUD). Therefore, this paper uses Breaking Free Online (BFO), a computer-assisted therapy program for SUD, as an example of how the clinical techniques contained within such an intervention might be mapped onto the BCTTv1. The developers of BFO were able to produce a full list of the clinical techniques contained within BFO. Exploratory mapping of the BCTTv1 onto the clinical content of the BFO program was conducted separately by the authors of the paper. This included the developers of the BFO program and psychology professionals working within the SUD field. These coded techniques were reviewed by the authors and any discrepancies in the coding were discussed between all authors until an agreement was reached. The BCTTv1 was mapped onto the clinical content of the BFO program. At least one behavioral change technique was found in 12 out of 16 grouping categories within the BCTTv1. A total of 26 out of 93 behavior change techniques were identified across the clinical content of the program. This exploratory mapping exercise has identified the specific behavior change techniques contained within BFO, and has provided a means of describing these techniques in a standardized way using the BCTTv1 terminology. It has also provided an opportunity for the BCTTv1 mapping process to be reported to the wider SUD treatment community, as it may have real utility in the development and evaluation of other psychosocial and behavioral change interventions within this field.

 



Long-term efficacy of a Web-based computer-tailored nutrition education intervention for adults including cognitive and environmental feedback: a randomized controlled trial.

Linda Springvloet, Lilian Lechner, Hein De Vries, Anke Oenema

BMC public health [15:372] (2015)

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Unhealthy diets are prevalent in Western countries, especially among low-educated people. To have an effect on health, it is important that dietary changes are sustained over time. This study examines long-term effects of a cognitive and environmental-feedback version of a Web-based computer-tailored (CT) nutrition education intervention targeting fruit, vegetables, high-energy snacks and saturated fat. A randomized controlled trial was conducted with a basic (tailored intervention targeting individual cognitions and self-regulation processes; n = 456), plus (additionally targeting environmental-level factors; n = 459) and control group (generic nutrition information; n = 434). Participants were recruited from the general population and randomly assigned to a study group. Online self-reported questionnaires assessed fruit, vegetable, high-energy snack and saturated fat intake, self-regulation, self-control, and Body Mass Index (BMI) at baseline and nine-months post-intervention. Linear mixed model analyses examined group differences in change over time. Educational differences were examined by 'group X time X education' interaction terms. Effects were examined in the total sample and among participants who did not comply with dietary- or BMI guidelines. The effects on vegetable intake in the total sample differed according to educational level (p = 02). Among low/moderate-educated participants, the basic version was significantly more effective in increasing vegetable intake than the control program (effect size (ES) = 0.32) and plus version (ES = 0.22). No effects were found for high-educated participants. Self-regulation change was significantly larger in the control group than in the basic (ES = 0.18) and plus (ES = 0.16) group. In general, both intervention versions did not result in long-term intervention effects. The exception was an effect of the basic version on self-reported vegetable intake among low/moderate-educated adults in the total sample. More research is needed on how targeting self-regulation processes and environmental-level factors in Web-based CT nutrition education interventions can increase long-term efficacy. Netherlands Trial Registry NTR3396 .

 


Short-term effects of a randomized computer-based out-of-school smoking prevention trial aimed at elementary schoolchildren.

Marlein Ausems, Ilse Mesters, Gerard van Breukelen, Hein De Vries

Preventive medicine [34:581-9] (2002)

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Smoking prevention programs usually run during school hours. In our study, an out-of-school program was developed consisting of a computer-tailored intervention aimed at the age group before school transition (11- to 12-year-old elementary schoolchildren). The aim of this study is to evaluate the additional effect of out-of-school smoking prevention. One hundred fifty-six participating schools were randomly allocated to one of four research conditions: (a) the in-school condition, an existing seven-lesson program; (b) the out-of-school condition, three computer-tailored letters sent to the students' homes; (c) the in-school and out-of-school condition, a combined approach; (d) the control condition. Pretest and 6 months follow-up data on smoking initiation and continuation, and data on psychosocial variables were collected from 3,349 students. Control and out-of-school conditions differed regarding posttest smoking initiation (18.1 and 10.4%) and regarding posttest smoking continuation (23.5 and 13.1%). Multilevel logistic regression analyses showed positive effects regarding the out-of-school program. Significant effects were not found regarding the in-school program, nor did the combined approach show stronger effects than the single-method approaches. The findings of this study suggest that smoking prevention trials for elementary schoolchildren can be effective when using out-of-school computer-tailored interventions.

 


Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial.

Alex Bahar-Fuchs, Shannon Webb, Lauren Bartsch, Linda Clare, George Rebok, Nicolas Cherbuin, Kaarin Anstey

Journal of Alzheimer's disease : JAD [60:889-911] (2017)

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Computerized Cognitive Training (CCT) has been shown to improve cognitive function in older adults with mild cognitive impairment (MCI) or mood-related neuropsychiatric symptoms (MrNPS), but many questions remain unresolved. To evaluate the extent to which CCT benefits older adults with both MCI and MrNPS, and its effects on meta-cognitive and non-cognitive outcomes, as well as establish whether adapting difficulty levels and tailoring to individuals' profile is superior to generic training. Older adults with MCI (n = 9), MrNPS (n = 11), or both (MCI+, n = 25) were randomized into a home-based individually-tailored and adaptive CCT (n = 21) or an active control condition (AC; n = 23) in a double-blind design. Interventions lasted 8-12 weeks and outcomes were assessed after the intervention, and at a 3-month follow-up. Participants in both conditions reported greater satisfaction with their everyday memory following intervention and at follow-up. However, participants in the CCT condition showed greater improvement on composite measures of memory, learning, and global cognition at follow-up. Participants with MrNPS in the CCT condition were also found to have improved mood at 3-month follow-up and reported using fewer memory strategies at the post-intervention and follow-up assessments. There was no evidence that participants with MCI+ were disadvantaged relative to the other diagnostic conditions. Finally, informant-rated caregiver burden declined at follow-up assessment in the CCT condition relative to the AC condition. Home-based CCT with adaptive difficulty and personal tailoring appears superior to more generic CCT in relation to both cognitive and non-cognitive outcomes. Mechanisms of treatment effect and future directions are discussed.

 


Systematic Development of the YouRAction program, a computer-tailored physical activity promotion intervention for Dutch adolescents, targeting personal motivations and environmental opportunities.

Richard Prins, Pepijn van Empelen, Marielle Beenackers, Johannes Brug, Anke Oenema

BMC public health [10:474] (2010)

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Increasing physical activity (PA) among adolescents is an important health promotion goal. PA has numerous positive health effects, but the majority of Dutch adolescents do not meet PA requirements. The present paper describes the systematic development of a theory-based computer-tailored intervention, YouRAction, which targets individual and environmental factors determining PA among adolescents. The intervention development was guided by the Intervention Mapping protocol, in order to define clear program objectives, theoretical methods and practical strategies, ensure systematic program planning and pilot-testing, and anticipate on implementation and evaluation. Two versions of YouRAction were developed: one that targets individual determinants and an extended version that also provides feedback on opportunities to be active in the neighbourhood. Key determinants that were targeted included: knowledge and awareness, attitudes, self-efficacy and subjective norms. The extended version also addressed perceived availability of neighbourhood PA facilities. Both versions aimed to increase levels of moderate-to-vigorous PA among adolescents. The intervention structure was based on self-regulation theory, comprising of five steps in the process of successful goal pursuit. Monitoring of PA behaviour and behavioural and normative feedback were used to increase awareness of PA behaviour; motivation was enhanced by targeting self-efficacy and attitudes, by means of various interactive strategies, such as web movies; the perceived environment was targeted by visualizing opportunities to be active in an interactive geographical map of the home environment; in the goal setting phase, the adolescents were guided in setting a goal and developing an action plan to achieve this goal; in the phase of active goal pursuit adolescents try to achieve their goal and in the evaluation phase the achievements are evaluated. Based on the results of the evaluation adolescents could revise their goal or choose another behaviour to focus on. The intervention is delivered in a classroom setting in three lessons. YouRAction will be evaluated in a cluster-randomized trial, with classes as unit of randomization. Evaluation will focus on PA outcomes, cognitive mediators/moderators and process measures. The planned development of YouRAction resulted in two computer-tailored interventions aimed at the promotion of PA in a Dutch secondary school setting. NTR1923.

 


Computerized versus motivational interviewing alcohol interventions: impact on discrepancy, motivation, and drinking.

James Murphy, Ashley Dennhardt, Jessica Skidmore, Matthew Martens, Meghan McDevitt-Murphy

Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors [24:628-39] (2010)

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The authors conducted two randomized clinical trials with ethnically diverse samples of college student drinkers in order to determine (a) the relative efficacy of two popular computerized interventions versus a more comprehensive motivational interview approach (BASICS) and (b) the mechanisms of change associated with these interventions. In Study 1, heavy drinking participants recruited from a student health center (N = 74, 59% women, 23% African American) were randomly assigned to receive BASICS or the Alcohol 101 CD-ROM program. BASICS was associated with greater post-session motivation to change and self-ideal and normative discrepancy relative to Alcohol 101, but there were no group differences in the primary drinking outcomes at 1-month follow-up. Pre to post session increases in motivation predicted lower follow-up drinking across both conditions. In Study 2, heavy drinking freshman recruited from a core university course (N = 133, 50% women, 30% African American) were randomly assigned to BASICS, a web-based feedback program (e-CHUG), or assessment-only. BASICS was associated with greater post-session self-ideal discrepancy than e-CHUG, but there were no differences in motivation or normative discrepancy. There was a significant treatment effect on typical weekly and heavy drinking, with participants in BASICS reporting significantly lower follow-up drinking relative to assessment only participants. In Study 2, change in the motivation or discrepancy did not predict drinking outcomes. Across both studies, African American students assigned to BASICS reported medium effect size reductions in drinking whereas African American students assigned to Alcohol 101, e-CHUG, or assessment did not reduce their drinking.

 



Computerized cognitive training for older diabetic adults at risk of dementia: Study protocol for a randomized controlled trial.

Rachel Bloom, Michal Schnaider-Beeri, Ramit Ravona-Springer, Anthony Heymann, Hai Dabush, Lior Bar, Shirel Slater, Yuri Rassovsky, Alex Bahar-Fuchs

Alzheimer's & dementia (New York, N. Y.) [3:636-650] (2017)

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Older adults with type 2 diabetes are at high risk of cognitive decline and dementia and form an important target group for dementia risk reduction studies. Despite evidence that computerized cognitive training (CCT) may benefit cognitive performance in cognitively healthy older adults and those with mild cognitive impairment, whether CCT may benefit cognitive performance or improve disease self-management in older diabetic adults has not been studied to date. In addition, whether adaptive difficulty levels and tailoring of interventions to individuals' cognitive profile are superior to generic training remains to be established. Ninety community-dwelling older (age ≥ 65) diabetic adults are recruited and randomized into a tailored and adaptive computerized cognitive training condition or to a generic, nontailored, or adaptive CCT condition. Both groups complete an 8-week training program using the commercially available CogniFit program. The intervention is augmented by a range of behavior-change techniques, and participants in each condition are further randomized into a global or cognition-specific phone-based self-efficacy (SE) condition, or a no-SE condition. The primary outcome is global cognitive performance immediately after the intervention. Secondary outcomes include diabetes self-management, meta-memory, mood, and SE. This pilot study is the first trial evaluating the potential benefits of home-based tailored and adaptive CCT in relation to cognitive and disease self-management in older diabetic adults. Methodological strengths of this trial include the double-blind design, the clear identification of the proposed active ingredients of the intervention, and the use of evidence-based behavior-change techniques. Results from this study will indicate whether CCT has the potential to lower the risk of diabetes-related cognitive decline. The outcomes of the trial will also advance our understanding of essential intervention parameters required to improve or maintain cognitive function and enhance disease self-management in this at-risk group.

 


A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol.

Henricus-Paul Cremers, Liesbeth Mercken, Anke Oenema, Hein De Vries

BMC public health [12:277] (2012)

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Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years) entitled 'Fun without Smokes'. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT) with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils' smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the 'Fun without Smokes' website. The main outcome measures will be ever smoking and the utilisation of the 'Fun without Smokes' website. Measurements will be carried out at baseline, 12 months and 24 months of follow-up. The present study protocol describes the purpose, intervention design and study protocol of 'Fun without Smokes'. Expectations are that pupils receiving tailored advice will be less likely to smoke after 24 months in contrast to pupils in the control condition. Furthermore, tailored feedback letters and prompting is expected to be more effective than providing tailored feedback letters only. Dutch Trial Register NTR3116.

 


Short-term efficacy of a web-based computer-tailored nutrition intervention: main effects and mediators.

A Oenema, F Tan, J Brug

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine [29:54-63] (2005)

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This study evaluates the short-term efficacy and respondents' evaluations of a Web-based computer-tailored nutrition intervention, aiming to decrease saturated fat intake and increase fruit and vegetable intake. Perceived personal relevance, individualization, and interestingness of the information were tested as mediators of the effects of the tailored intervention. The objective was to study the short-term effects of a Web-based computer-tailored nutrition intervention. Respondents (N = 782) were randomly assigned to a tailored intervention group, a generic nutrition information control group, or a no-information control group. Fat, fruit, and vegetable intakes and behavioral determinants were measured at baseline and at 3 weeks postintervention. Posttest group differences were determined by multiple linear regression analyses. The computer-tailored intervention produced significant effects for the determinants of fat, fruit, and vegetable intake and for vegetable and fruit intake. The tailored information was rated as more personally relevant, individualized, interesting, and new than the generic nutrition information. Perceived personal relevance, individualization, and interestingness were identified as mediators of some of the tailoring effects. The findings of this study indicate that Web-based, computer-tailored nutrition information can have a short-term effect on the determinants of fat, fruit, and vegetable intake. The effect of the tailored information may be partly explained by the perceived personal relevance and individualization of the information.

 


The impact of a computer-tailored nutrition intervention.

J Brug, I Steenhuis, Assema van, Hein De Vries

Preventive medicine [25:236-42] ()

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Nutrition education tailored to individual characteristics of people might be more effective than general nutrition education. Nowadays, the use of computers makes individualized feedback available for larger groups. The impact of tailored nutrition information on changes in fat, vegetable, and fruit consumption was tested in a randomized trial among 347 employees of a major oil company. Respondents in the experimental group received computer-generated feedback letters tailored to their personal dietary behavior, attitudes, perceived social influences, self-efficacy expectations, and awareness levels. Respondents in the control group received general nutrition information. Respondents in the experimental group decreased their fat consumption significantly more than the control group between baseline and posttest. A significant effect of tailoring was also found for changes in attitudes and intentions toward reducing fat intake and increasing fruit and vegetable consumption. Furthermore, respondents in the experimental group were more satisfied with the nutrition information they received and more often reported changing their diet or intention as a result of the information. It is concluded that computer-tailored nutrition information is a promising means of stimulating people to change their diet toward dietary recommendations.

 


Using computer, mobile and wearable technology enhanced interventions to reduce sedentary behaviour: a systematic review and meta-analysis.

Aoife Stephenson, Suzanne McDonough, Marie Murphy, Chris Nugent, Jacqueline Mair

The international journal of behavioral nutrition and physical activity [14:105] (2017)

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High levels of sedentary behaviour (SB) are associated with negative health consequences. Technology enhanced solutions such as mobile applications, activity monitors, prompting software, texts, emails and websites are being harnessed to reduce SB. The aim of this paper is to evaluate the effectiveness of such technology enhanced interventions aimed at reducing SB in healthy adults and to examine the behaviour change techniques (BCTs) used. Five electronic databases were searched to identify randomised-controlled trials (RCTs), published up to June 2016. Interventions using computer, mobile or wearable technologies to facilitate a reduction in SB, using a measure of sedentary time as an outcome, were eligible for inclusion. Risk of bias was assessed using the Cochrane Collaboration's tool and interventions were coded using the BCT Taxonomy (v1). Meta-analysis of 15/17 RCTs suggested that computer, mobile and wearable technology tools resulted in a mean reduction of -41.28 min per day (min/day) of sitting time (95% CI -60.99, -21.58, I2 = 77%, n = 1402), in favour of the intervention group at end point follow-up. The pooled effects showed mean reductions at short (≤ 3 months), medium (>3 to 6 months), and long-term follow-up (>6 months) of -42.42 min/day, -37.23 min/day and -1.65 min/day, respectively. Overall, 16/17 studies were deemed as having a high or unclear risk of bias, and 1/17 was judged to be at a low risk of bias. A total of 46 BCTs (14 unique) were coded for the computer, mobile and wearable components of the interventions. The most frequently coded were "prompts and cues", "self-monitoring of behaviour", "social support (unspecified)" and "goal setting (behaviour)". Interventions using computer, mobile and wearable technologies can be effective in reducing SB. Effectiveness appeared most prominent in the short-term and lessened over time. A range of BCTs have been implemented in these interventions. Future studies need to improve reporting of BCTs within interventions and address the methodological flaws identified within the review through the use of more rigorously controlled study designs with longer-term follow-ups, objective measures of SB and the incorporation of strategies to reduce attrition. The review protocol was registered with PROSPERO: CRD42016038187.