- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00379925
Effectiveness of a Church-Based Program at Increasing Physical Activity and Healthy Dietary Habits in African Americans
A Partnership to Promote Physical Activity and Healthy Eating in AME Churches
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many obesity-related diseases, including diabetes, cancer, and heart disease, occur more frequently in ethnic minorities than in Caucasians. African Americans have an extremely high church attendance rate, making church-based interventions a viable method to reach a wide audience and positively influence health habits and behaviors. The most effective way to prevent or reverse the effects of obesity is through weight loss, which can be accomplished by increasing physical activity and following a low fat and low sodium diet that emphasizes fruits, vegetables, and whole grains. Few programs have been developed that have specifically examined the effects of a church-based physical activity and dietary intervention. This study will encourage church leaders to assist in the development of a health promotion program that will incorporate the church's social, cultural, and policy influences. The purpose of the study is to evaluate the effectiveness of the intervention on increasing physical activity, improving blood pressure levels, and promoting healthy dietary habits among church members. The importance of pastor support and participation will be evaluated, and the results from this study may be used to develop additional church-based interventions across a larger geographic area.
In Year 1 of this 5-year study, representatives from the Palmetto Conference of the African Methodist Episcopal (AME) Church and three state universities in South Carolina will participate in monthly planning sessions to develop the intervention. Local health committees and church pastors and cooks will be trained to implement the program. The 18-month intervention will occur in three waves; where at least 60 churches will be randomly assigned to participate in either the immediate intervention or delayed intervention. The program will emphasize increased physical activity and the adaptation of a healthy diet that includes low fat and low sodium foods, fruits, vegetables, and whole grains. At baseline and Month 18, blood pressure will be measured, and physical activity levels and fruit and vegetable intake will be assessed for some church members. Additionally, throughout the study, some participants will wear an accelerometer, which is a small device that measures physical activity levels.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
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Lane, South Carolina, United States, 29564
- African Methodist Episcopal Churches in South Carolina
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Member of a church in the Palmetto Conference of the 7th Episcopal District of the AME Church
- Attends church services or events at least once per month
Exclusion Criteria:
- Planning to move in the 18 months following study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral
Participants will take part in the Physical Activity and Dietary Health Promotion Program.
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Churches within the intervention group will receive a committee training and church cook training designed to teach them how to do a self-assessment of current practices and develop a plan for their program.
The intervention is based on the structural model of health behavior and targets opportunities, mass media (within the church), guidelines and policies, and church environment.
Intervention churches also receive monthly intervention mailings to support intervention implementation.
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No Intervention: Delayed intervention
Participants are assigned to a delayed intervention group and serve as a no-intervention control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 15 months
|
Systolic and diastolic blood pressure
|
15 months
|
Physical activity (measured with the Community Healthy Activities Model Program For Seniors [CHAMPS] questionnaire)
Time Frame: 15 months
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Self-report measure of physical activity
|
15 months
|
Fruit and vegetable consumption (measured with NCI screener & 2-item measure)
Time Frame: 15 months
|
self-report measure of physical activity
|
15 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity (measured with an accelerometer)
Time Frame: 15 months
|
Accelerometer measured physical activity
|
15 months
|
Fat consumption
Time Frame: 15 months
|
Self-reported measure of practices associated with fat consumption
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15 months
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Fiber consumption
Time Frame: 15 months
|
Self-reported measure of practices associated with fiberconsumption
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15 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara Wilcox, PhD, University of South Carolina
Publications and helpful links
General Publications
- Kyryliuk R, Baruth M, Wilcox S. Predictors of Weight Loss for African-American Women in the Faith, Activity, and Nutrition (FAN) Study. J Phys Act Health. 2015 May;12(5):659-65. doi: 10.1123/jpah.2013-0220. Epub 2014 Jun 4.
- Saunders RP, Wilcox S, Baruth M, Dowda M. Process evaluation methods, implementation fidelity results and relationship to physical activity and healthy eating in the Faith, Activity, and Nutrition (FAN) study. Eval Program Plann. 2014 Apr;43:93-102. doi: 10.1016/j.evalprogplan.2013.11.003. Epub 2013 Dec 10.
- Wilcox S, Parrott A, Baruth M, Laken M, Condrasky M, Saunders R, Dowda M, Evans R, Addy C, Warren TY, Kinnard D, Zimmerman L. The Faith, Activity, and Nutrition program: a randomized controlled trial in African-American churches. Am J Prev Med. 2013 Feb;44(2):122-31. doi: 10.1016/j.amepre.2012.09.062. Erratum In: Am J Prev Med. 2013 Jun;44(6):694-5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00005414
- R01HL083858 (U.S. NIH Grant/Contract)
- R01HL083858-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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