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ObesityNCT02173366

Change Clubs for African American Women

A study testing Change Club Intervention in people with Obesity and Cardiovascular Disease, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Cardiovascular Disease
What is being tested?
Change Club Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Dec 2013to 1 Feb 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Friedman School of Nutrition, Tufts University

    Boston, Massachusetts, 02111

Other trials in United States

About this study

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

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.

Being tested
Change Club Intervention
Medical subject headings
Obesity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Change Club InterventionBehavioural

Study groups in NCT02173366
Study groupRoleWhat they receive
Change Club InterventionExperimentalNot described
Receives: Behavioral: Change Club Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (10)

  1. Change in Diet from Pre to Post-Intervention (6 Months)

    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.

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

  2. Change in Physical Activity Level from Pre to Post-Intervention (6 Months)

    Physical activity levels will be measured objectively using accelerometers (ActiGraph GT3X worn for 7 days) and by self-report (7-Day Physical Activity Recall).

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

  3. Change in Blood Pressure from Pre to Post-Intervention (6 Months)

    Blood pressure will be measured to the nearest 1mm Hg using a validated automated monitor (Omron HEM-705CP), using American Heart Association guidelines.

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

  4. Change in Cardiorespiratory Fitness Level from Pre to Post-Intervention (6 Months)

    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.

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

  5. Change in Self-Efficacy from Pre to Post-Intervention (6 Months)

    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.

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

  6. Change in Collective Efficacy from Pre to Post-Intervention (6 Months)

    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.

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

  7. Change in Percent Body Fat from Pre to Post-Intervention (6 Months)

    Percent body fat will be measured by bioelectric impedance using a Tanita TBF-410 Bioelectric Impedance Body Composition Analyzer.

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

  8. Change in Perceived Stress from Pre to Post-Intervention (6 Months)

    Perceived stress will be measured using the validated 14-item Perceived Stress Scale (Cohen 1983).

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

  9. Change in Level of Civic Engagement from Pre to Post-Intervention (6 Months)

    We will use the Civic Engagement Scale (Doolittle and Faul 2013) to assess civic engagement.

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

  10. Change in Level of Self-Regulation from Pre to Post-Intervention (6 Months)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionNov 2015
  4. Study completion1 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02173366
Sponsor's protocol ID
11244
Status last verified
Sep 2017
First submitted
10 Jun 2014
Last updated
5 Sep 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 28118823

Questions about this trial

What is this clinical trial studying?

A study testing Change Club Intervention in people with Obesity and Cardiovascular Disease, run by Tufts University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02173366, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.

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