Clinical trial NCT02173366: Change Clubs for African American Women
Official title: Preliminary Investigation of Civic Engagement as a Novel Approach to Behavior Change and Body Weight Improvement in African American Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Disease
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Boston Nutrition Obesity Research Center (administered by Boston Medical Center)
First posted: 2014-06-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Weight from Pre to Post-Intervention (6 Months)
timeFrame: 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)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Physical Activity Level from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Blood Pressure from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Cardiorespiratory Fitness Level from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Self-Efficacy from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Collective Efficacy from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Percent Body Fat from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Perceived Stress from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Level of Civic Engagement from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
measure: Change in Level of Self-Regulation from Pre to Post-Intervention (6 Months)
timeFrame: pre-post; participants will be followed for the 6-month intervention period
Other outcomes:
measure: Adherence
timeFrame: attendance will be monitored throughout the 6-month intervention period
measure: Retention
timeFrame: participant retention will be monitored throughout the 6-month intervention period
Locations:
city: Boston
country: United States
facility: Friedman School of Nutrition, Tufts University
state: Massachusetts
Study officials:
References:
citation: Brown AG, Hudson LB, Chui K, Metayer N, Lebron-Torres N, Seguin RA, Folta SC. Improving heart health among Black/African American women using civic engagement: a pilot study. BMC Public Health. 2017 Jan 24;17(1):112. doi: 10.1186/s12889-016-3964-2.