Change Clubs for African American Women

NCT02173366 | Completed

• 1 other identifier: 11244
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (10)

• Change in Diet 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 Blood Pressure 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 Self-Efficacy from Pre to Post-Intervention (6 Months)

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

Other Outcomes (2)

• Adherence

  attendance will be monitored throughout the 6-month intervention period

• Retention

  participant retention will be monitored throughout the 6-month intervention period

Study Arms (1)

Change Club Intervention

EXPERIMENTAL

Behavioral: Change Club Intervention

Interventions

Change Club Intervention BEHAVIORAL

Change Club Intervention

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tufts University: lead
• Boston Nutrition Obesity Research Center (administered by Boston Medical Center): collaborator

Study Sites (1)

Friedman School of Nutrition, Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 28118823 DERIVED

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 25, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2017
• Last Updated: September 5, 2017

Record last verified: 2017-09

Locations

US (1)