Dissemination and Implementation of Faith, Activity, and Nutrition

Sponsor
University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT02868866
Collaborator
(none)
1,807
3
2
56
602.3
10.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Immediate Intervention
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1807 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Faith, Activity, and Nutrition: Dissemination in Underserved Communities
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate intervention

Training of church committee followed by 12 months of technical assistance phone calls.

Behavioral: Immediate Intervention
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.

    Outcome Measures

    Primary Outcome Measures

    1. Adoption [12 months]

      (# of eligible churches that are trained / # of eligible churches)*100

    2. Reach [12 months]

      (# of church members in trained churches / # of members of all eligible churches)*100

    3. Implementation fidelity [12 months]

      Composite score consisting of implementation of core elements of the intervention

    4. Maintenance [24 months]

      organization maintenance of the intervention based on leader reports

    Secondary Outcome Measures

    1. physical activity [12 months]

      Self-reported proportion of members meeting physical activity recommendations using (only for phase 1 of study)

    2. fruit and vegetable intake [12 months]

      Self-reported cups per day of fruits and vegetables (only for phase 1 of study)

    3. Self-efficacy for physical activity [12 months]

      Self-reported self-efficacy for physical activity (average of scale items) (only for phase 1 of study)

    4. Self-efficacy for fruit and vegetable intake [12 months]

      Self-reported self-efficacy for fruit and vegetable intake (average of scale items) (only for phase 1 of study)

    Other Outcome Measures

    1. Church environment [12 months]

      Church environmental factors that impede or promote physical activity and healthy eating, assessed through staff observations (only for phase 1 of study)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clemson University Clemson South Carolina United States 29634
    2 University of South Carolina Columbia South Carolina United States 29208
    3 Fairfield Behavioral Health Services Winnsboro South Carolina United States 29180

    Sponsors and Collaborators

    • University of South Carolina

    Investigators

    • Principal Investigator: Sara J Wilcox, PhD, University of South Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Wilcox, Professor, University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT02868866
    Other Study ID Numbers:
    • Pro00036222
    First Posted:
    Aug 16, 2016
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Sara Wilcox, Professor, University of South Carolina

    Study Results

    No Results Posted as of Apr 28, 2021