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

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
      • Clemson, South Carolina, United States, 29634
        • Clemson University
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina
      • Winnsboro, South Carolina, United States, 29180
        • Fairfield Behavioral Health Services

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:
  • Faith, Activity, and Nutrition
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
Self-reported self-efficacy for physical activity (average of scale items) (only for phase 1 of study)
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.

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.

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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