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How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the 'Active Herts' physical activity programme.

Neil Howlett, Andy Jones, Lucy Bain, Angel Chater

BMJ open [7:e017783] (2017)

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There is a high prevalence of inactive adults in the UK, and many suffer from conditions such as cardiovascular disease (CVD) or poor mental health. These coexist more frequently in areas of higher socioeconomic deprivation. There is a need to test the effectiveness, acceptability and sustainability of physical activity programmes. Active Herts uses novel evidence-based behaviour change techniques to target physical inactivity. Active Herts is a community physical activity programme for inactive adults aged 16+ with one or more risk factors for CVD and/or a mild to moderate mental health condition. This evaluation will follow a mixed-methods longitudinal (baseline, and 3-month, 6-month and 12-month follow-ups) design. Pragmatic considerations mean delivery of the programme differs by locality. In two areas programme users will receive a behaviour change technique booklet, regular consultations, a booster phone call, motivational text messages and signposting to 12 weeks of exercise classes. In another two areas programme users will also receive 12 weeks of free tailored exercise classes, with optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, well-being, psychological capability and reflective motivation as secondary outcomes. A process evaluation will explore the views of stakeholders, delivery staff and programme leads. Economic evaluation will examine the programme costs against the benefits gained in terms of reduced risk of morbidity. This study was been approved by the Faculty of Medicine and Health Sciences Research Ethics Committee at the University of East Anglia. Informed written consent will be obtained from programme users in the evaluation. Results will be published in peer-reviewed journals, presented at conferences, and shared through the study website and local community outlets. ClinicalTrials.gov ID number: NCT03153098.


Multicentre RCT and economic evaluation of a psychological intervention together with a leaflet to reduce risk behaviour amongst men who have sex with men (MSM) prescribed post-exposure prophylaxis for HIV following sexual exposure (PEPSE): a protocol.

Carrie Llewellyn, Charles Abraham, Alec Miners, Helen Smith, Alex Pollard, Paul Benn, Martin Fisher

BMC infectious diseases [12:70] (2012)

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Post-exposure prophylaxis (PEP) following sexual exposure to HIV has been recommended as a method of preventing HIV infection in the UK. Men who have sex with men (MSM) are the group most affected by HIV in the UK and their sexual risk taking behaviour is reported to be increasing. One-to-one behavioural interventions, such as motivational interviewing (MI) have been recommended to reduce HIV in high risk groups. The Information, Motivation and Behavioral skills (IMB) model has been shown to provide a good basis for understanding and predicting HIV-relevant health behaviour and health behaviour change, however the IMB has yet to be applied to PEP after risky sexual exposure. The primary aim of this trial is to examine the impact of MI augmented with information provision and behavioural skills building (informed by the IMB Model), over and above usual care, on risky sexual behaviour in MSM prescribed PEP after potential sexual exposure. A secondary aim of this research is to examine the impact of the intervention on adherence to PEP. This study will also provide estimates of the cost-effectiveness of the intervention. A manualised parallel group randomised controlled trial with economic evaluation will be conducted. The primary outcome is the proportion of risky sexual practices. Secondary outcomes include: i) Levels of adherence to PEP treatment; ii) Number of subsequent courses of PEP; iii) Levels of motivation to avoid risky sexual behaviours; iv) Levels of HIV risk-reduction information/knowledge; v) Levels of risk reduction behavioural skills; vi) Diagnosis of anal gonorrhoea, Chlamydia and/or HIV. 250 participants will be asked to self-complete a questionnaire at four time points during the study (at 0,3,6,12 months). The intervention will consist of a two-session, fixed duration, telephone administered augmented MI intervention based on the IMB model. A newly developed treatment manual will guide the selection of persuasive communication strategies as appropriate for each participant and will be based on underlying change mechanisms specified by the IMB theoretical framework. Information provision and skills building will also be included in the intervention package through the use of information leaflets and tailored action plans. Fidelity of intervention delivery will be assessed. The results from this NIHR funded study will identify whether it is appropriate and cost-effective to intervene using one-to-one telephone calls with MSM seeking PEP. If the intervention is effective, further work will be needed on training staff to deliver the intervention competently. UKCRN ID:11436; ISRCTN00746242.


Optimizing personalized normative feedback: the use of gender-specific referents.

Melissa Lewis, Clayton Neighbors

Journal of studies on alcohol and drugs [68:228-37] (2007)

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Many brief interventions include personalized normative feedback (PNF) using gender-specific or gender-neutral referents. Several theories suggest that information pertaining to more socially proximal referents should have greater influence on one's behavior compared with more socially distal referents. The current research evaluated whether gender specificity of the normative referent employed in PNF related to intervention efficacy. Following baseline assessment, 185 college students (45.2% women) were randomly assigned to one of three intervention conditions: gender-specific feedback, gender-neutral feedback, or assessment-only control. Immediately after completing measures of perceived norms, alcohol consumption, and gender identity, participants in the gender-neutral and gender-specific intervention conditions were provided with computerized information detailing their own drinking behavior, their perceptions of student drinking, and actual student drinking. After a 1-month follow-up, the results indicated that normative feedback was effective in changing perceived norms and reducing alcohol consumption for both intervention groups for women and men. The results provide support, however, for changes in perceived gender-specific norms as a mediator of the effects of normative feedback on reduced drinking behavior for women only. Additionally, gender-specific feedback was found to be more effective for women higher in gender identity, relative to the gender-neutral feedback. A post-assessment follow-up telephone survey administered to assess potential demand characteristics corroborated the intervention effects. Results extend previous research documenting efficacy of computer delivered PNF. Gender specificity and gender identity appear to be important elements to consider for PNF intervention efficacy for women.


Testing the Implementation of a Pain Self-management Support Intervention for Oncology Patients in Clinical Practice: A Randomized Controlled Pilot Study (ANtiPain).

Antje Koller, Jan Gaertner, Sabina De Geest, Monika Hasemann, Gerhild Becker

Cancer nursing (2017)

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In oncology, pain control is a persistent problem. Significant barriers to cancer pain management are patient related. Pain self-management support interventions have shown to reduce pain intensity and patient-related barriers. Comparative effectiveness research is a suitable approach to test whether effects are sustained in clinical practice. In this pilot randomized controlled trial, the implementation of the ANtiPain intervention into clinical practice was tested to assess the effects on pain intensity, function-related outcomes, self-efficacy, and patient-related barriers to pain management to prepare a larger effectiveness trial. Within 14 months, 39 adult oncology patients with pain scores of 3 or higher on a 10-point numeric rating scale were recruited in an academic comprehensive cancer center in Southern Germany. Patients in the control group (n=19) received standard care. Patients in the intervention group (n=20) received ANtiPain, a cancer pain self-management support intervention based on 3 key strategies: provision of information, skill building, and nurse coaching. An intervention session was performed in-hospital. After discharge, follow-up was provided via telephone calls. Data were collected at baseline and 1 and 6 weeks after discharge. Effect sizes were calculated for all outcomes. Large effects were found for activity hindrance (Cohen d=0.90), barriers (d=0.91), and self-efficacy (d=0.90). Small to moderate effects were found for average and worst pain (Cohen d=0.17-0.45). Key findings of this study involved function-related outcomes and self-efficacy. Because these outcomes are particularly meaningful for patients, the integration of ANtiPain to routine clinical practice may be substantial. A larger study will be based on these findings.


Cancer prevention for working class, multi-ethnic populations through health centers: the healthy directions study.

Karen Emmons, Anne Stoddard, Caitlin Gutheil, Elizabeth Suarez, Rebecca Lobb, Robert Fletcher

Cancer causes & control : CCC [14:727-37] (2003)

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This paper presents the study design and baseline data from Healthy Directions-Health Centers (HCs), a study designed to address social contextual factors in cancer prevention interventions for working class, multi-ethnic populations. This study is part of the Harvard Cancer Prevention Program Project. Ten community HCs were paired and randomly assigned to intervention or control. Patients who resided in low income, multi-ethnic neighborhoods were identified and approached for participation. This study targeted fruit and vegetable consumption, red meat consumption, multi-vitamin intake, and physical activity. The intervention components consisted of: (1) a brief in-person study endorsement from the participant's clinician at a scheduled routine care visit; (2) an initial in-person counseling session with a health advisor; (3) four follow-up telephone counseling sessions; (4) multiple mailings of tailored materials; and (5) linkages to relevant activities in the local community. Fifteen percent of the sample smoked, 86% reported eating fewer than five servings of fruits and vegetables per day, 50% reported eating more than the recommended amounts of red meat, 40% did not meet recommended physical activity levels, and 63% did not take a multi-vitamin on a daily basis. Although overall social support was high, participants reported low levels of social norms for the target prevention behaviors. Other social contextual mediators and modifying factors are reported. By examining the relationships between social contextual factors and health behaviors, it may be possible to enhance the effectiveness of interventions aimed at reducing social inequalities in risk behaviors.


A randomised controlled trial and mediation analysis of the 'Healthy Habits', telephone-based dietary intervention for preschool children.

Amanda Fletcher, Luke Wolfenden, Rebecca Wyse, Jenny Bowman, Patrick McElduff, Sarah Duncan

The international journal of behavioral nutrition and physical activity [10:43] (2013)

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Consumption of non-core foods in childhood is associated with excessive weight gain in childhood. Parents play a vital role in establishing healthy diet behaviours in young children. The aim of this study was to assess the effectiveness of a telephone-based intervention in reducing child consumption of non-core foods, and to examine parent and home food environment mediators of change in child consumption. The 'Healthy Habits' trial utilised a clustered randomised controlled design. Parents were recruited from 30 preschools (N=394 participants, mean age 35.2±5.6 years). Parents randomized to the intervention group received four telephone contacts and print materials. Parents allocated to the control condition receive generic print materials only. Non-core food consumption was assessed using a validated child dietary questionnaire at baseline, 2 and 6 months post recruitment in 2010. The intervention was effective in reducing child consumption of non-core foods at 2 months (intention to treat analysis: z=-2.83, p<.01), however this effect was not maintained at 6 months. Structural equation modelling using 2 month data indicated that child access to non-core foods in the home and child feeding strategies mediated the effect of the intervention. The telephone-based intervention shows promise in improving short term dietary behaviour in preschool age children, however further development is needed to sustain the effect in the long-term. Australian Clinical Trials Registry: ACTRN12609000820202.


Evaluating a community-based walking intervention for hypertensive older people in Taiwan: a randomized controlled trial.

LL Lee, A Arthur, M Avis

Preventive medicine [44:160-6] (2007)

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To study the effect of a community-based walking intervention on blood pressure among older people. The study design was a randomized controlled trial conducted in a rural area of Taiwan between October 2002 and June 2003. A total of 202 participants aged 60 years and over with mild to moderate hypertension was recruited. Participants randomized to the intervention group (n=102) received a six-month community-based walking intervention based on self-efficacy theory. A public health nurse provided both face-to-face and telephone support designed to assist participants to increase their walking. Control group participants (n=100) received usual primary health care. Primary outcome was change in systolic blood pressure and secondary outcomes were exercise self-efficacy, self-reported walking and diastolic blood pressure. At six-month follow-up the mean change in systolic blood pressure was a decrease of 15.4 mmHg and 8.4 mmHg in the intervention and control group, respectively. The difference in mean change between the two groups was -7.0 mmHg (95% CI, -11.5 to -2.5 mmHg, p=0.002). Improvement in exercise self-efficacy scores was greater among intervention group participants (mean difference 1.23, 95% CI, 0.5 to 2.0, p=0.001). Intervention group participants were more likely to report walking more (p<0.0005) but no differences were observed in diastolic blood pressure (p=0.19). Among hypertensive older people, a six-month community-based walking intervention was effective in increasing their exercise self-efficacy and reducing systolic blood pressure.


Vitalum study design: RCT evaluating the efficacy of tailored print communication and telephone motivational interviewing on multiple health behaviors.

Hilde M van Keulen, Ilse Mesters, Johannes Brug, Marlein Ausems, Marci Campbell, Ken Resnicow, Paul Zwietering, Gerard van Breukelen, Willem van Mechelen, Johan Severens, Hein De Vries

BMC public health [8:216] (2008)

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A large proportion of adults fail to meet public health guidelines for physical activity as well as fruit, vegetable and fat intake. Interventions are needed to improve these health behaviors. Both computer tailoring and motivational interviewing have shown themselves to be promising techniques for health behavior change. The Vitalum project aims to compare the efficacy of these techniques in improving the health behaviors of adults aged 45-70. This paper describes the design of the Vitalum study. Dutch general medical practices (N = 23) were recruited via a registration network or by personal invitation. The participants were then enrolled through these general practices using an invitational letter. They (n = 2,881) received a written baseline questionnaire to assess health behaviors, and potential psychosocial and socio-demographic behavioral determinants. A power analysis indicated that 1,600 participants who were failing to meet the guidelines for physical activity and either fruit or vegetable consumption were needed. Eligible participants were stratified based on hypertension status and randomized into one of four intervention groups: tailored print communication, telephone motivational interviewing, combined, and control. The first two groups either received four letters or took part in four interviews, whereas the combined group received two letters and took part in two interviews in turns at 5, 13, 30 and 43 weeks after returning the baseline questionnaire. Each letter and interview focused on physical activity or nutrition behavior. The participants also took part in a telephone survey 25 weeks after baseline to gather new information for tailoring. There were two follow-up questionnaires, at 47 and 73 weeks after baseline, to measure short- and long-term effects. The control group received a tailored letter after the last posttest. The process, efficacy and cost-effectiveness of the interventions will be examined by means of multilevel mixed regression, cost-effectiveness analyses and process evaluation. The Vitalum study simultaneously evaluates the efficacy of tailored print communication and telephone motivational interviewing, and their combined use for multiple behaviors and people with different motivational stages and education levels. The results can be used by policymakers to contribute to evidence-based prevention of chronic diseases. Dutch Trial Register NTR1068.


Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors.

Wendy Demark-Wahnefried, Miriam Morey, Elizabeth Clipp, Carl Pieper, Denise Snyder, Richard Sloane, Harvey Cohen

Controlled clinical trials [24:206-23] (2003)

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The U.S. population is aging, bringing with it an increased prevalence of chronic disease and concomitant declines in physical function. The risk of developing cancer increases significantly with age, and functional decline is much more likely once a cancer diagnosis is rendered. Thus, functional status in later life is a key concern, one that is heightened among elders who have been diagnosed with cancer. To date, however, there have been few trials that have exclusively addressed issues related to cancer survivorship among older cancer patients, and to our knowledge, none has focused on preserving or enhancing physical functioning. This paper describes the study design and methodological considerations of a randomized controlled trial to determine if a personally tailored workbook and telephone counseling program can positively affect physical activity and dietary behaviors and ultimately the physical functioning of up to 420 older men and women newly diagnosed with breast or prostate cancer. This trial is unique because the cancer diagnosis is used not only as a marker of risk for functional decline, but also as a "teachable moment" - an opportune time when elders may be more receptive to making beneficial lifestyle changes. Undoubtedly, as cure rates for cancer increase and intersect with ever-growing numbers of elderly, there will be numerous opportunities to provide and test interventions within this vulnerable population and to target functional status as a primary outcome. In reporting our methods, we hope to give others "a leg up," so that they can hurdle with greater ease the barriers we experienced, and thus advance the field more rapidly.


Effectiveness of physician-based assessment and counseling for exercise in a staff model HMO.

S Norris, L Grothaus, D Buchner, M Pratt

Preventive medicine [30:513-23] (2000)

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Few primary care physicians routinely counsel for exercise, despite the benefits of physical activity and the high prevalence of inactivity. The objective of this study is to assess the effectiveness of Physician-Based Assessment and Counseling for Exercise (PACE), a brief, behavior-based tool for primary care providers counseling healthy adults. This study is a randomized controlled trial of 812 patients age 30 years or older registered for well visits at 32 primary care physician offices at a staff model health maintenance organization. Intervention physicians were trained to deliver PACE exercise counseling protocols at the index visit, and one reminder telephone call occurred at 1 month. An enhanced intervention group received additional activity reminders. At the 6-month follow-up, the control group did not differ significantly from the intervention group for energy expended (2,048 kcal/week versus 2,108 kcal/ week, P = 0.77), time spent in walking or other moderate to vigorous activities (202 min/week versus 187 min/ week, P = 0.99), mental health, physical function, or behaviors previously shown to predict activity change. Among the intervention patients, the stages-of-change score for Contemplators increased significantly compared with controls (P = 0.03), but without a significant change in energy expended. Baseline levels of physical activity counseling were high (50%), as were baseline patient physical activity levels (61% exercised at least three times a week). These results suggest that a one-time PACE counseling session with minimal reinforcement, in a setting with high baseline levels of activity, does not further increase activity. The finding that Contemplators advanced in stage of behavior change suggests that further studies are needed to examine long-term, repeated counseling interventions.


Referral for Expert Physical Activity Counseling: A Pragmatic RCT.

Erica James, Ben Ewald, Natalie Johnson, Fiona Stacey, Wendy Brown, Elizabeth Holliday, Mark Jones, Fan Yang, Charlotte Hespe, Ronald Plotnikoff

American journal of preventive medicine (2017)

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Primary care physicians are well placed to offer physical activity counseling, but insufficient time is a barrier. Referral to an exercise specialist is an alternative. In Australia, exercise specialists are publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. This trial aimed to (1) determine the efficacy of primary care physicians' referral of insufficiently active patients for counseling to increase physical activity, compared with usual care, and (2) compare the efficacy of face-to-face counseling with counseling predominantly via telephone. Three-arm pragmatic RCT. Two hundred three insufficiently active (<7,000 steps/day) primary care practice patients (mean age 57 years; 70% female) recruited in New South Wales, Australia, in 2011-2014. (1) Five face-to-face counseling sessions by an exercise specialist, (2) one face-to-face counseling session followed by four telephone calls by an exercise specialist, or (3) a generic mailed physical activity brochure (usual care). The counseling sessions operationalized social cognitive theory via a behavior change counseling framework. Change in average daily step counts between baseline and 12 months. Data were analyzed in 2016. Forty (20%) participants formally withdrew; completion rates at 3 and 6 months were 64% and 58%, respectively. Intervention attendance was high (75% received five sessions). The estimated mean difference between usual care and the combined intervention groups at 12 months was 1,002 steps/day (95% CI=244, 1,759, p=0.01). When comparing face-to-face with predominantly telephone counseling, the telephone group had a non-significant higher mean daily step count (by 619 steps) at 12 months. Provision of expert physical activity counseling to insufficiently active primary care patients resulted in a significant increase in physical activity (approximately 70 minutes of walking per week) at 12 months. Face-to-face only and counseling conducted predominantly via telephone were both effective. This trial provides evidence to expand public funding for expert physical activity counseling and for delivery via telephone in addition to face-to-face consultations. This trial is registered at www.anzctr.org.au/ ACTRN12611000884909.


A randomized controlled trial of an office-based physical activity and physical fitness intervention for older adults.

Janet Purath, Colleen Keller, Sterling McPherson, Barbara Ainsworth

Geriatric nursing (New York, N.Y.) [34:204-11] ()

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This primary care-based study aimed to evaluate the efficacy and feasibility of a 24-week intervention on physical activity and physical fitness in a group of community-dwelling older adults. Secondary aims were to determine the effect of the intervention on self-efficacy and barriers to physical activity. Intervention participants (n = 36) received an exercise prescription based on physical fitness test results and personal choice. Comparison participants (n = 36) received a nutrition intervention. Both groups received 10 follow-up telephone calls. Repeated measures ANOVA analyses showed no direct effects of the intervention on the primary outcomes of physical activity or physical fitness in the intervention group (p > 0.05). Secondary analyses with ANCOVA that included potential moderating variables of age, gender, income, BMI, and support for physical activity showed that the intervention group significantly increased frequency of all physical activity (F = 3.50, p < 0.05) as well as the fitness outcomes of lower body strength (F = 3.63, p < 0.05) and aerobic endurance (F = 4.03, p < 0.05). This is one of the first studies to evaluate the use of fitness measures to increase physical activity and fitness in the primary care setting. The intervention improved some aspects of physical activity and fitness for selected participants.


The Logan Healthy Living Program: a cluster randomized trial of a telephone-delivered physical activity and dietary behavior intervention for primary care patients with type 2 diabetes or hypertension from a socially disadvantaged community--rationale, design and recruitment.

Elizabeth Eakin, Marina Reeves, Sheleigh Lawler, Brian Oldenburg, Chris Del Mar, Ken Wilkie, Adele Spencer, Diana Battistutta, Nicholas Graves

Contemporary clinical trials [29:439-54] (2008)

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Physical activity and dietary behavior changes are important to both the primary prevention and secondary management of the majority of our most prevalent chronic conditions (i.e., cardiovascular disease, hypertension, type 2 diabetes, breast and colon cancer). With over 85% of Australian adults visiting a general practitioner each year, the general practice setting has enormous potential to facilitate wide scale delivery of health behaviour interventions. However, there are also many barriers to delivery in such settings, including lack of time, training, resources and remuneration. Thus there is an important need to evaluate other feasible and effective means of delivering evidence-based physical activity and dietary behaviour programs to patients in primary care, including telephone counseling interventions. Using a cluster randomized design with practice as the unit of randomization, this study evaluated a telephone-delivered intervention for physical activity and dietary change targeting patients with chronic conditions (type 2 diabetes or hypertension) recruited from primary care practices in a socially disadvantaged community in Queensland, Australia. Ten practices were randomly assigned to the telephone intervention or to usual care, and 434 patients were recruited. Patients in intervention practices received a workbook and 18 calls over 12 months. Assessment at baseline, 4-, 12- and 18-months allows for assessment of initial change and maintenance of primary outcomes (physical activity and dietary behavior change) and secondary outcomes (quality of life, cost-effectiveness, support for health behavior change). This effectiveness trial adds to the currently limited number of telephone-delivered intervention studies targeting both physical activity and dietary change. It also addresses some of the shortcomings of previous trials by targeting patients from a disadvantaged community, and by including detailed reporting on participant representativeness, intervention implementation and cost-effectiveness, as well as an evaluation of maintenance of health behavior change.


PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial.

Tom Yates, Simon Griffin, Danielle Bodicoat, Gwen Brierly, Helen Dallosso, Melanie Davies, Helen Eborall, Charlotte Edwardson, Mike Gillett, Laura Gray, Wendy Hardeman, Sian Hill, Katie Morton, Stephen Sutton, Jacqui Troughton, Kamlesh Khunti

Trials [16:289] (2015)

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The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes. A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40-74 years for White European, or 25-74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4% (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants. Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change. This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention. ISRCTN83465245 Trial registration date: 14/06/2012.


Structured goal planning and supportive telephone followup in rheumatology care: results from a pragmatic stepped-wedge cluster-randomized trial.

Gunnhild Berdal, Ingvild Bø, Turid Dager, Anne Dingsør, Siv Eppeland, Jon Hagfors, Bente Hamnes, Petter Mowinckel, Merete Nielsen, Anne-Lene Sand-Svartrud, Bente Slungaard, Sigrid Wigers, Kåre Hagen, Hanne Dagfinrud, Ingvild Kjeken

Arthritis care & research (2018)

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To evaluate patient-reported health effects of an add-on structured goal planning and supportive telephone followup rehabilitation program compared with traditional rehabilitation programs in patients with rheumatic diseases. In this pragmatic stepped-wedge cluster-randomized controlled trial 389 patients with rheumatic diseases recruited from six rehabilitation centres received either traditional rehabilitation or traditional rehabilitation extended with an add-on program tailored to individual needs. The add-on program comprised a self-management booklet and usage of motivational interviewing in structured individualized goal planning and four supportive followup phone-calls after discharge. Data were collected by questionnaires on admission and discharge from rehabilitation stay, and 6 months and 12 months after discharge. Primary outcome was health-related quality of life (HR-QoL) measured by the Patient Generated Index (PGI, 0-100, 0=low). Secondary outcomes included patient-reported health status, self-efficacy, pain, fatigue, global disease activity and motivation for change. The main statistical analysis was a linear repeated measures mixed model performed on the intention to treat population using all available data. A significant treatment effect of the add-on intervention on HR-QoL was found on discharge (mean difference = 3.32 [95% CI: 0.27, 6.37], p=0.03). No significant between-group differences were found after 6 or 12 months. Both groups showed positive changes in HR-QoL following rehabilitation which gradually declined, although the values remained at higher levels after 6 and 12 months compared with baseline values. The add-on program enhanced the short-term effect of rehabilitation with respect to patient-specific HR-QoL, but it did not prolong the effect as intended. This article is protected by copyright. All rights reserved.


Cost-effectiveness comparison of five interventions to increase mammography screening.

R Saywell, V Champion, C Skinner, D McQuillen, D Martin, M Maraj

Preventive medicine [29:374-82] (1999)

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Mammography is the primary method used for breast cancer screening. However, compliance with recommended screening practices is still below acceptable levels. This study examined the cost-effectiveness of five combinations of physician recommendation and telephone or in-person individualized counseling strategies for increasing compliance with mammography. There were 808 participants who were randomly assigned to one of six groups. A logistic regression model with compliance as the dependent variable and group as the independent variable was used to test for significant differences and a ratio of cost to improvement in mammogram compliance evaluated the cost-effectiveness. Three of the interventions (in-person, telephone plus letter, and in-person plus letter) had significantly better compliance rates compared with the control, physician letter, or telephone alone. However, when considering costs, only one emerged as the superior strategy. The cost-effectiveness ratios for the five interventions show that telephone-plus-letter is the most cost-effective strategy, achieving a 35.6% mammography compliance at a marginal cost of $0.78 per 1% increase in women screened. A tailored phone prompt and physician reminder is an effective and economical intervention to increase mammography. Future research should confirm this finding and address its applicability to practice.


Comparisons of tailored mammography interventions at two months postintervention.

Victoria Champion, Celette Skinner, Usha Menon, Roopa Seshadri, Deborah Anzalone, Susan Rawl

Annals of behavioral medicine : a publication of the Society of Behavioral Medicine [24:211-8] (2002)

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The recent decrease in breast cancer mortality has been linked in part to increased breast cancer screening. Although the percentage of women screened once is rising, rate of continued adherence is poor. The purpose of this article is to assess the effects of tailored mammography interventions implemented prospectively in a factorial design contrasting groups receiving either (a) usual care (no intervention), (b) tailored telephone counseling for mammography, (c) tailored mailed materials promoting mammography, or (d) a combination of tailored mail and telephone counseling. This prospective, randomized study with a 2 x 2 factorial design included women 51 years and older (N = 1,367) who were not adherent with mammography at baseline. The intervention is based on integration of the Transtheoretical and Health Belief Models. Participants were enrolled in one of two health maintenance organizations or seen in a university-related primary care clinic. Baseline data were collected on mammography history and beliefs and knowledge related to mammography. Data were collected via telephone interviews using previously developed scales. The follow-up interviewers were conducted with 976 women. The sample was 41% White, 56% African American, and 3% other. Mean age at baseline was 66.5. Logistic regression indicates that postintervention mammography status in all three intervention groups was significantly better than usual care, with odds ratios ranging from 1.66 (telephone only) to 2.16 (telephone plus mail).


Project PREVENT: a randomized trial to reduce multiple behavioral risk factors for colon cancer.

Karen Emmons, Colleen McBride, Elaine Puleo, Kathryn Pollak, Elizabeth Clipp, Karen Kuntz, Bess Marcus, Melissa Napolitano, Jane Onken, Frank Farraye, Robert Fletcher

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology [14:1453-9] (2005)

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This report examines the outcome data for Project PREVENT, a two-site randomized control trial designed to reduce behavioral risk factors for colorectal cancer among individuals who have been diagnosed with adenomatous colon polyps. The study sample included 1,247 patients with recent diagnosis of adenomatous colorectal polyps. Within 4 weeks following the polypectomy, participants completed a baseline survey by telephone, and were randomized to either Usual Care (UC) or the PREVENT intervention, which was designed to target multiple risk factors. The intervention consisted of a telephone-delivered intervention plus tailored materials, and focused on the six primary behavioral risk factors for colorectal cancer, including red meat consumption, fruit and vegetable intake, multivitamin intake, alcohol, smoking, and physical inactivity. Participation in the PREVENT intervention was associated with a significantly greater reduction in prevalence of multiple risk factors for colorectal cancer compared with UC. Only about one third of UC participants dropped any risk factors during the study period, compared with almost half of the PREVENT participants. PREVENT participants were also significantly more likely to change more than one behavior than UC participants. The PREVENT intervention was effective in helping patients change multiple risk factors. These results provide further support that more comprehensive interventions that move beyond emphasis on a single risk factor are acceptable to patient populations, can result in improvements, and are cost effective.


Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA).

Kate Jolly, Jenny Ingram, Joanne Clarke, Debbie Johnson, Heather Trickey, Gill Thomson, Stephan Dombrowski, Alice Sitch, Fiona Dykes, Max Feltham, Kirsty Darwent, Christine MacArthur, Tracy Roberts, Pat Hoddinott

BMJ open [8:e019142] (2018)

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Breast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman's feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care. A two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper-women interactions to assess intervention fidelity. Study results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol. ISRCTN14760978; Pre-results.