- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868866
Dissemination and Implementation of Faith, Activity, and Nutrition
April 26, 2021 updated by: Sara Wilcox, University of South Carolina
Faith, Activity, and Nutrition: Dissemination in Underserved Communities
This dissemination and implementation study will examine the impact of the Faith, Activity, and Nutrition (FAN) program on both church practices and member behaviors in both a countywide (randomized trial) and statewide (quasi-experimental) study.
Guided by two theoretical frameworks, the specific aims of the applied research project are to: 1) examine the adoption and reach of FAN in churches and organizational factors associated with adoption; 2) characterize implementation fidelity and multilevel factors associated with implementation; 3) describe organizational maintenance of FAN and factors associated with maintenance; and 4) study the effectiveness of FAN.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The USC PRC's applied research project will study the dissemination and implementation of an evidence-based program shown previously to significantly increase physical activity and fruit and vegetable intake in churches in South Carolina (Faith, Activity, and Nutrition; FAN).
Guided by two theoretical frameworks, the specific aims of the applied research project are to: 1) examine the adoption and reach of FAN in churches and organizational factors associated with adoption; 2) characterize implementation fidelity and multilevel factors associated with implementation; 3) describe organizational maintenance of FAN and factors associated with maintenance; and 4) study the effectiveness of FAN.
In Phase 1, churches in a rural county with a high proportion of African American residents will be randomized to receive training in FAN from a community health advisor (n=40) or to be part of a delayed intervention control group (n=20).
In Phase 2, a quasi-experimental study will be done with a large religious denomination in SC (churches are not randomized).
Study Type
Interventional
Enrollment (Actual)
1807
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Carolina
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Clemson, South Carolina, United States, 29634
- Clemson University
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Columbia, South Carolina, United States, 29208
- University of South Carolina
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Winnsboro, South Carolina, United States, 29180
- Fairfield Behavioral Health Services
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Phase 1 churches: church in Fairfield County, SC with at least 20 members who regularly attend worship service
- Phase 2 churches: church in the SC Conference of the United Methodist Church
- Members (phase 1): adult who regularly attends church participating in the study
Exclusion Criteria:
- Members (phase 1): under the age of 18
- Members (phase 1): does not regularly attend church participating in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Immediate intervention
Training of church committee followed by 12 months of technical assistance phone calls.
|
Committees from 40 churches will be trained in the Faith, Activity, and Nutrition program by Community Health Advisors.
The training focuses on helping churches create healthier church environments for physical activity and healthy eating using Cohen's structural model of health behavior as a guide.
Each church committee participates in a full-day training and submits a program plan and budget.
Churches receive materials to support implementation of the program.
After the full-day training, trained churches receive 12 monthly technical assistance calls to help them implement their program plan.
The church coordinator receives 8 calls and the pastor receives 4 calls over the 12 months.
In Phase 2, the intervention is open to any church in the SC Conference of the United Methodist Church.
Other Names:
|
No Intervention: Delayed intervention
20 churches are followed but receive no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adoption
Time Frame: 12 months
|
(# of eligible churches that are trained / # of eligible churches)*100
|
12 months
|
Reach
Time Frame: 12 months
|
(# of church members in trained churches / # of members of all eligible churches)*100
|
12 months
|
Implementation fidelity
Time Frame: 12 months
|
Composite score consisting of implementation of core elements of the intervention
|
12 months
|
Maintenance
Time Frame: 24 months
|
organization maintenance of the intervention based on leader reports
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
physical activity
Time Frame: 12 months
|
Self-reported proportion of members meeting physical activity recommendations using (only for phase 1 of study)
|
12 months
|
fruit and vegetable intake
Time Frame: 12 months
|
Self-reported cups per day of fruits and vegetables (only for phase 1 of study)
|
12 months
|
Self-efficacy for physical activity
Time Frame: 12 months
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Self-reported self-efficacy for physical activity (average of scale items) (only for phase 1 of study)
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12 months
|
Self-efficacy for fruit and vegetable intake
Time Frame: 12 months
|
Self-reported self-efficacy for fruit and vegetable intake (average of scale items) (only for phase 1 of study)
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Church environment
Time Frame: 12 months
|
Church environmental factors that impede or promote physical activity and healthy eating, assessed through staff observations (only for phase 1 of study)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara J Wilcox, PhD, University of South Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wilcox S, Day KR, Saunders RP, Jake-Schoffman DE, Kaczynski AT, Stucker J, Dunn CG, Bernhart JA. The Faith, Activity, and Nutrition (FAN) dissemination and implementation study: changes in and maintenance of organizational practices over 24 months in a statewide initiative. Int J Behav Nutr Phys Act. 2022 Mar 2;19(1):23. doi: 10.1186/s12966-022-01253-9.
- Wilcox S, Saunders RP, Jake-Schoffman D, Hutto B. The Faith, Activity, and Nutrition (FAN) Dissemination and Implementation Study: 24-Month Organizational Maintenance in a Countywide Initiative. Front Public Health. 2020 May 14;8:171. doi: 10.3389/fpubh.2020.00171. eCollection 2020.
- Wilcox S, Saunders RP, Kaczynski AT, Forthofer M, Sharpe PA, Goodwin C, Condrasky M, Kennedy VL Sr, Jake-Schoffman DE, Kinnard D, Hutto B. Faith, Activity, and Nutrition Randomized Dissemination and Implementation Study: Countywide Adoption, Reach, and Effectiveness. Am J Prev Med. 2018 Jun;54(6):776-785. doi: 10.1016/j.amepre.2018.02.018. Epub 2018 Apr 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
September 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
August 11, 2016
First Posted (Estimate)
August 16, 2016
Study Record Updates
Last Update Posted (Actual)
April 28, 2021
Last Update Submitted That Met QC Criteria
April 26, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Pro00036222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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