? All interventions

Evaluating a small change approach to preventing long term weight gain in overweight and obese adults--Study rationale, design, and methods.

Robert Ross, James Hill, Amy Latimer, Andrew Day

Contemporary clinical trials [47:275-81] (2016)

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Despite the rapid rise in obesity worldwide, few strategies have been effective in treating this epidemic. An emerging strategy is to focus on preventing excessive weight gain rather than weight reduction. The proposed intervention, small change approach (SCA), is an innovative weight gain prevention strategy in which individuals monitor their usual nutrition and physical activity patterns and then make modest but sustainable alterations through behavioral intervention techniques (self-regulation, goal setting) enough to reduce overall energy balance by 100 to 200 kcal per day (e.g., reduce caloric intake by 100 kcal per day and/or increase daily step count by ~2000 steps (~100 kcal) per day). The primary aim of the trial is to determine whether small changes in energy expenditure and/or energy intake prevent weight gain in overweight and obese men and women long-term. The pre-specified primary and secondary assessments are at 2 and 3 years post-randomization respectively. The primary outcome is change in body weight. Secondary outcomes include body composition variables (adipose tissue distribution and lean mass distribution) and cardiorespiratory fitness (VO2peak). We randomized 320 primarily White (n=305) overweight and obese men and women to one of 2 conditions: 1) usual care (UC), 2) small change approach (SCA). Participant involvement in the study is 3 years; 2 year intervention with a 1 year follow-up. Our study findings will indicate whether there is value in clinicians adopting a SCA to lifestyle counseling for their patients who are overweight and obese.


Moms in motion: a group-mediated cognitive-behavioral physical activity intervention.

Anita Cramp, Lawrence Brawley

The international journal of behavioral nutrition and physical activity [3:23] (2006)

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When examining the prevalence of physical inactivity by gender and age, women over the age of 25 are at an increased risk for sedentary behavior. Childbearing and motherhood have been explored as one possible explanation for this increased risk. Post natal exercise studies to date demonstrate promising physical and psychological outcomes, however few physical activity interventions have been theory-driven and tailored to post natal exercise initiates. The purpose of this study was to compare the effects of a group-mediated cognitive behavioral intervention based upon social-cognitive theory and group dynamics (GMCB) to a standard care postnatal exercise program (SE). A randomized, two-arm intervention design was used. Fifty-seven post natal women were randomized to one of two conditions: (1) a standard exercise treatment (SE) and (2) a standard exercise treatment plus group-mediated cognitive behavioral intervention (GMCB). Participants in both conditions participated in a four-week intensive phase where participants received standard exercise training. In addition, GMCB participants received self-regulatory behavioral skills training via six group-mediated counseling sessions. Following the intensive phase, participants engaged in a four-week home-based phase of self-structured exercise. Measures of physical activity, barrier efficacy, and proximal outcome expectations were administered and data were analyzed using ANCOVA procedures. ANCOVA of change scores for frequency, minutes, and volume of physical activity revealed significant treatment effects over the intensive and home-based phases (p's < 0.01). In addition, ANCOVA of change in mean barrier efficacy and proximal outcome expectations at the conclusion of the intensive phase demonstrated that GMCB participants increased their initial level of barrier efficacy and outcome expectations while SE participants decreased (p < 0.05). While both exercise programs resulted in improvements to exercise participation, the GMCB intervention produced greater improvement in overall physical activity, barrier efficacy and proximal outcome expectations.


Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients.

Zakkoyya Lewis, Kenneth Ottenbacher, Steve Fisher, Kristofer Jennings, Arleen Brown, Maria Swartz, Elizabeth Lyons

JMIR research protocols [5:e59] (2016)

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Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users. The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders. The study started recruitment in October 2015 and is scheduled to be completed by October 2016. This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level. ClinicalTrials.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT).


Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial.

Nancy Allen, James Fain, Barry Braun, Stuart Chipkin

Diabetes research and clinical practice [80:371-9] (2008)

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Despite the known benefits, 60% of individuals with diabetes do not engage in regular physical activity (PA). This pilot study tested the effects of a counseling intervention using continuous glucose monitoring system (CGMS) feedback on PA self-efficacy, PA levels, and physiological variables. Adults (N=52) with type 2 diabetes (non-insulin requiring, inactive) were randomized to intervention (n=27) or control (n=25) groups. Both groups received 90min of diabetes education with a follow-up phone call 4 weeks later. The intervention group also received counseling derived from self-efficacy theory. This intervention included feedback on each participant's CGMS graph and used role model CGMS graphs to clearly depict glucose reductions in response to PA. Outcomes were assessed at baseline and 8 weeks. Participants receiving the intervention had higher self-efficacy scores than the control group for sticking to activity/resisting relapse at 8 weeks (p<0.05), indicating more confidence in maintaining a PA program. Intervention group participants light/sedentary activity minutes decreased significantly (p<0.05), moderate activity minutes increased significantly (p<0.05), and, HbA1c and BMI decreased significantly (p<0.05). These data suggest that PA counseling interventions using CGMS feedback for individuals with type 2 diabetes may improve PA levels and reduce risk factors for diabetes-related complications.


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.


The effects of smoking cessation counseling by midwives on Dutch pregnant women and their partners.

Hein De Vries, Martijntje Bakker, Patricia Dolan Mullen, Gerard van Breukelen

Patient education and counseling [63:177-87] (2006)

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Smoking during pregnancy is an important problem in the Netherlands. We tested the effectiveness of a health counseling method by midwives using a RCT. Four provinces with 42 practices including 118 midwives were randomly assigned to the experimental or control condition. Midwives in the experimental group provided brief health counseling, self-help materials on smoking cessation during pregnancy and early postpartum, and a partner booklet. Controls received routine care. The main outcome measures were 7-day abstinence, continuous abstinence, and partner smoking at 6 weeks post-intervention (T1) and 6 weeks postpartum (T2). Multi-level analysis revealed significant differences between both conditions at T1 and T2 using intention-to-treat analysis. Nineteen percent of the experimental group reported 7-day abstinence compared to 7% of the control group at T1, and 21 and 12%, respectively, at T2. For continuous abstinence these percentages were 12% in the experimental group and 3% in the control group. The partner intervention was not successful. The intervention resulted in significant effects on smoking behavior for pregnant women, but not for partner smoking. The program realized short-term effects. An important precondition is that midwives need a proper training.


Counseling for health behavior change in people with COPD: systematic review.

Marie Williams, Tanja Effing, Catherine Paquet, Carole Gibbs, Hayley Lewthwaite, Katrina Li Lok Sze, Anna Phillips, Kylie Johnston

International journal of chronic obstructive pulmonary disease [12:2165-2178] (2017)

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Counseling has been suggested as a promising approach for facilitating changes in health behavior. The aim of this systematic review of counseling interventions for people with COPD was to describe: 1) counseling definitions, 2) targeted health behaviors, 3) counseling techniques and 4) whether commonalities in counseling techniques were associated with improved health behaviors. Ten databases were searched for original randomized controlled trials which included adults with COPD, used the term "counseling" as a sole or component of a multifaceted intervention and were published in the previous 10 years. Data extraction, study appraisal and coding for behavior change techniques (BCTs) were completed by two independent reviewers. Data were synthesized descriptively, with meta-analysis conducted where possible. Of the 182 studies reviewed as full-text, 22 were included. A single study provided a definition for counseling. Two key behaviors were the main foci of counseling: physical activity (n=9) and smoking cessation (n=8). Six studies (27%) reported underlying models and/or theoretical frameworks. Counseling was the sole intervention in 10 studies and part of a multicomponent intervention in 12. Interventions targeting physical activity included a mean of 6.3 (±3.1) BCTs, smoking cessation 4.9 (±2.9) BCTs and other behaviors 6.5 (±3.9) BCTs. The most frequent BCTs were social support unspecified (n=22; 100%), goal setting behavior (n=11), problem-solving (n=11) and instructions on how to perform the behavior (n=10). No studies shared identical BCT profiles. Counseling had a significant positive effect for smoking cessation and positive but not significant effect for physical activity. Counseling for health behavior change was rarely defined and effectiveness varied by target behavior. Provision of specific details when reporting studies of counseling interventions (definition, BCTs, dosage) would allow clarification of the effectiveness of counseling as an approach to health behavior change in people with COPD.


Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial.

Maria Kennelly, Kate Ainscough, Karen Lindsay, Eileen Gibney, Mary McCarthy, Fionnuala McAuliffe

Contemporary clinical trials [46:92-9] (2016)

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Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chronic diseases. The aim of this study is to assess the impact of a 'healthy lifestyle package' with mHealth smart phone technology as support compared with usual care on the incidence of GDM in an overweight and obese pregnant population. We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI ≥25kg/m(2)-39.9kg/m(2). Patients are randomized to control or intervention group in a 1:1 ratio. The intervention arm healthy lifestyle package includes a motivational counseling session to encourage behavior change, involving targeted, low GI nutritional advice and daily physical activity prescription delivered before 18weeks gestation, as well as a smart phone app to provide ongoing healthy lifestyle advice and support throughout pregnancy. The primary outcome is the incidence of GDM at 29weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference. This will be the first clinical trial to evaluate the effectiveness of a smart phone technology-assisted targeted healthy lifestyle intervention, which is grounded in behavior change theories and techniques, to support antenatal management of an overweight and obese pregnant population in preventing GDM.


Jigsaw Puzzles As Cognitive Enrichment (PACE) - the effect of solving jigsaw puzzles on global visuospatial cognition in adults 50 years of age and older: study protocol for a randomized controlled trial.

Patrick Fissler, Olivia Küster, Laura Loy, Daria Laptinskaya, Martin Rosenfelder, Christine AF von Arnim, Iris-Tatjana Kolassa

Trials [18:415] (2017)

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Neurocognitive disorders are an important societal challenge and the need for early prevention is increasingly recognized. Meta-analyses show beneficial effects of cognitive activities on cognition. However, high financial costs, low intrinsic motivation, logistic challenges of group-based activities, or the need to operate digital devices prevent their widespread application in clinical practice. Solving jigsaw puzzles is a cognitive activity without these hindering characteristics, but cognitive effects have not been investigated yet. With this study, we aim to evaluate the effect of solving jigsaw puzzles on visuospatial cognition, daily functioning, and psychological outcomes. The pre-posttest, assessor-blinded study will include 100 cognitively healthy adults 50 years of age or older, who will be randomly assigned to a jigsaw puzzle group or a cognitive health counseling group. Within the 5-week intervention period, participants in the jigsaw puzzle group will engage in 30 days of solving jigsaw puzzles for at least 1 h per day and additionally receive cognitive health counseling. The cognitive health counseling group will receive the same counseling intervention but no jigsaw puzzles. The primary outcome, global visuospatial cognition, will depict the average of the z-standardized performance scores in visuospatial tests of perception, constructional praxis, mental rotation, processing speed, flexibility, working memory, reasoning, and episodic memory. As secondary outcomes, we will assess the eight cognitive abilities, objective and subjective visuospatial daily functioning, psychological well-being, general self-efficacy, and perceived stress. The primary data analysis will be based on mixed-effects models in an intention-to-treat approach. Solving jigsaw puzzles is a low-cost, intrinsically motivating, cognitive leisure activity, which can be executed alone or with others and without the need to operate a digital device. In the case of positive results, these characteristics allow an easy implementation of solving jigsaw puzzles in clinical practice as a way to improve visuospatial functioning. Whether cognitive impairment and loss of independence in everyday functioning might be prevented or delayed in the long run has to be examined in future studies. ClinicalTrials.gov, NCT02667314 . Registered on 27 January 2016.


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.


A brief intervention changing oral self-care, self-efficacy, and self-monitoring.

Ralf Schwarzer, Agata Antoniuk, Maryam Gholami

British journal of health psychology [20:56-67] (2015)

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The roles of self-efficacy and self-monitoring as proximal predictors of dental flossing frequency are studied in the context of an oral health intervention. A study among 287 university students, aged 19 to 26 years, compared an intervention group that received a brief self-regulatory treatment, with a passive and an active control group. Dental flossing, self-efficacy, and self-monitoring were assessed at baseline and 3 weeks later. The intervention led to an increase in dental flossing regardless of experimental condition. However, treatment-specific gains were documented for self-efficacy and self-monitoring. Moreover, changes in the latter two served as mediators in a path model, linking the intervention with subsequent dental flossing and yielding significant indirect effects. Self-efficacy and self-monitoring play a mediating role in facilitating dental flossing. Interventions that aim at an improvement in oral self-care should consider using these constructs. Statement of contribution What is already known on this subject? The adoption and maintenance of oral self-care can be facilitated by a number of social-cognitive variables. Interventions that include planning, action control, or self-efficacy components have been shown to improve dental flossing. In one recent study on flossing in adolescent girls, planning intervention effects were mediated by self-efficacy. What does this study add? Self-monitoring is associated with better oral self-care. A 10-min intervention improves self-efficacy and self-monitoring. Self-efficacy and self-monitoring operate as mediators between treatment and flossing.