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Clinical Trials/NCT02173366
NCT02173366
Completed
Not Applicable

Preliminary Investigation of Civic Engagement as a Novel Approach to Behavior Change and Body Weight Improvement in African American Females

Tufts University1 site in 1 country26 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Tufts University
Enrollment
26
Locations
1
Primary Endpoint
Change in Weight from Pre to Post-Intervention (6 Months)
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
February 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Change in Weight from Pre to Post-Intervention (6 Months)

Time Frame: pre-post; participants will be followed for the 6-month intervention period

Body weight will be measured in triplicate to the nearest 0.5 kg using a digital floor scale (Seca 876).

Secondary Outcomes

  • Change in Self-Efficacy from Pre to Post-Intervention (6 Months)(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)(pre-post; participants will be followed for the 6-month intervention period)
  • Change in Percent Body Fat from Pre to Post-Intervention (6 Months)(pre-post; participants will be followed for the 6-month intervention period)
  • Change in Cardiorespiratory Fitness Level from Pre to Post-Intervention (6 Months)(pre-post; participants will be followed for the 6-month intervention period)
  • Change in Collective Efficacy from Pre to Post-Intervention (6 Months)(pre-post; participants will be followed for the 6-month intervention period)
  • Change in Diet from Pre to Post-Intervention (6 Months)(pre-post; participants will be followed for the 6-month intervention period)
  • Change in Blood Pressure from Pre to Post-Intervention (6 Months)(pre-post; participants will be followed for the 6-month intervention period)
  • Change in Physical Activity Level from Pre to Post-Intervention (6 Months)(pre-post; participants will be followed for the 6-month intervention period)
  • Change in Perceived Stress from Pre to Post-Intervention (6 Months)(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)(pre-post; participants will be followed for the 6-month intervention period)

Study Sites (1)

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