Overview

This trial is active, not recruiting.

Conditions obesity, cardiovascular disease
Treatment change club intervention
Sponsor Tufts University
Collaborator Boston Nutrition Obesity Research Center (administered by Boston Medical Center)
Start date December 2013
End date November 2015
Trial size 26 participants
Trial identifier NCT02173366, 11244

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose prevention
Arm
(Experimental)
change club intervention

Primary Outcomes

Measure
Change in Weight from Pre to Post-Intervention (6 Months)
time frame: pre-post; participants will be followed for the 6-month intervention period

Secondary Outcomes

Measure
Change in Diet from Pre to Post-Intervention (6 Months)
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)
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)
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)
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)
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)
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)
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)
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)
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)
time frame: pre-post; participants will be followed for the 6-month intervention period

Eligibility Criteria

Female participants from 30 years up to 70 years old.

Inclusion Criteria: - female; - age 30-70 years; - self-identified as African American; - English-speaking; - BMI ≥25.0; - currently sedentary (not meeting Physical Activity Guidelines for Americans); - safe to initiate moderate physical activity per the PAR-Q. Exclusion Criteria: - failure to provide informed consent; - participation in any other lifestyle modification program; - current use of either prescription or over-the-counter weight loss medications; - inability to communicate due to severe, - uncorrectable hearing loss or speech disorder; - severe visual impairment (if it precludes completion of assessments and/or intervention); - planning to move outside of area within 6 months; - pregnancy (since weight loss, the primary outcome, is inadvisable in this population).

Additional Information

Official title Preliminary Investigation of Civic Engagement as a Novel Approach to Behavior Change and Body Weight Improvement in African American Females
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Tufts University.