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Change Clubs for African American Women

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ClinicalTrials.gov Identifier: NCT02173366
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Boston Nutrition Obesity Research Center (administered by Boston Medical Center)
Information provided by (Responsible Party):
Tufts University

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 25, 2014
Last Update Posted Date September 5, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02173366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2014)
  • Change in Diet from Pre to Post-Intervention (6 Months) [ Time Frame: pre-post; participants will be followed for the 6-month intervention period ]
    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.
  • 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 ]
    Physical activity levels will be measured objectively using accelerometers (ActiGraph GT3X worn for 7 days) and by self-report (7-Day Physical Activity Recall).
  • 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 ]
    Blood pressure will be measured to the nearest 1mm Hg using a validated automated monitor (Omron HEM-705CP), using American Heart Association guidelines.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    Percent body fat will be measured by bioelectric impedance using a Tanita TBF-410 Bioelectric Impedance Body Composition Analyzer.
  • 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 ]
    Perceived stress will be measured using the validated 14-item Perceived Stress Scale (Cohen 1983).
  • 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 ]
    We will use the Civic Engagement Scale (Doolittle and Faul 2013) to assess civic engagement.
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 24, 2014)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Change Clubs for African American Women
Official Title  ICMJE Preliminary Investigation of Civic Engagement as a Novel Approach to Behavior Change and Body Weight Improvement in African American Females
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Cardiovascular Disease
Intervention  ICMJE Behavioral: Change Club Intervention
Study Arms  ICMJE Experimental: Change Club Intervention
Intervention: Behavioral: Change Club Intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2015)
26
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 1, 2017
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02173366
Other Study ID Numbers  ICMJE 11244
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tufts University
Study Sponsor  ICMJE Tufts University
Collaborators  ICMJE Boston Nutrition Obesity Research Center (administered by Boston Medical Center)
Investigators  ICMJE Not Provided
PRS Account Tufts University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP