An interventional study of Change Club Intervention in Obesity and Cardiovascular Disease, sponsored by Tufts University. Completed at 1 site in United States. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by Tufts University · Not applicable, Interventional, and Prevention
African American women have among the highest rates of overweight and obesity and few meet dietary or physical activity guidelines. The investigators seek to develop a new intervention strategy that will help alleviate health disparities, thereby improving quality of life, health care costs, and disease burden. The African American Collaborative Obesity Research Network (AACORN) recommends an eco-social, community-engaged approach to behavior change that is in line with cultural values of interconnectedness and care for others. The purpose of this study is to operationalize the AACORN paradigm to promote improvements in weight status and health through a civic engagement approach. To achieve this, participants will meet in church-based Change Clubs and be led through a 6 month curriculum, which includes both lessons in cardiovascular risk reduction and a civic engagement project. Civic engagement may lead to change in individual health behaviors by increasing self-regulation and self-efficacy. The investigators will measure club members' adherence to the Change Club intervention, defined as average number of sessions attended, retention in the clubs, satisfaction with the Change Club experience and achievement of at least 50% of self-identified benchmarks for community change within 6 months. In addition the investigators will compare anthropometric factors, diet and physical activity behaviors, blood pressure, cardiorespiratory fitness, and psychosocial factors before and after participation in the Change Club intervention.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 26 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria:
Behavioral: Change Club Intervention
Change in Weight from Pre to Post-Intervention (6 Months)
Body weight will be measured in triplicate to the nearest 0.5 kg using a digital floor scale (Seca 876).
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Diet from Pre to Post-Intervention (6 Months)
Two 24-hour recalls (1 weekday and 1 weekend day) will be collected. Data will be entered into the Nutrition Data System for Research (NDSR). Nutrient and food group calculations will be performed using the NDSR software.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Physical Activity Level from Pre to Post-Intervention (6 Months)
Physical activity levels will be measured objectively using accelerometers (ActiGraph GT3X worn for 7 days) and by self-report (7-Day Physical Activity Recall).
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Blood Pressure from Pre to Post-Intervention (6 Months)
Blood pressure will be measured to the nearest 1mm Hg using a validated automated monitor (Omron HEM-705CP), using American Heart Association guidelines.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Cardiorespiratory Fitness Level from Pre to Post-Intervention (6 Months)
Cardiovascular fitness will be measured using the Rockport 1-mile walk test. Participants will walk a flat, 1-mile course as fast as possible without running. Heart rate will be measured immediately after. VO2max will be estimated from validated formulas using 1-mile walk time, gender, age, body weight, and ending heart rate.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Self-Efficacy from Pre to Post-Intervention (6 Months)
Self-efficacy will be assessed the Weight Efficacy Life-Style Questionnaire (Clark 1991). The exercise self-efficacy scale contains 5 items measuring confidence in ability to exercise under various challenges.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Collective Efficacy from Pre to Post-Intervention (6 Months)
Collective efficacy will be measured using an adapted 8-item Likert style scale (Sampson, Raudebush, \& Earls 1997) that examines the extent to which individuals in a neighborhood or community trust and help others.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Percent Body Fat from Pre to Post-Intervention (6 Months)
Percent body fat will be measured by bioelectric impedance using a Tanita TBF-410 Bioelectric Impedance Body Composition Analyzer.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Perceived Stress from Pre to Post-Intervention (6 Months)
Perceived stress will be measured using the validated 14-item Perceived Stress Scale (Cohen 1983).
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Level of Civic Engagement from Pre to Post-Intervention (6 Months)
We will use the Civic Engagement Scale (Doolittle and Faul 2013) to assess civic engagement.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Change in Level of Self-Regulation from Pre to Post-Intervention (6 Months)
Self-regulation will be measured using a scale developed by Saelens et al. (2000) to measure self-regulatory skill usage for exercise and for controlled eating.
Time frame: pre-post; participants will be followed for the 6-month intervention period
Adherence
Time frame: attendance will be monitored throughout the 6-month intervention period
Retention
Time frame: participant retention will be monitored throughout the 6-month intervention period
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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