NCT02868866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,807

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

4.7 years

First QC Date

July 12, 2016

Last Update Submit

April 26, 2021

Conditions

Keywords

physical activitynutritionfruits and vegetablesfaith-basedchurches

Outcome Measures

Primary Outcomes (4)

  • Adoption

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

    12 months

  • Reach

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

    12 months

  • Implementation fidelity

    Composite score consisting of implementation of core elements of the intervention

    12 months

  • Maintenance

    organization maintenance of the intervention based on leader reports

    24 months

Secondary Outcomes (4)

  • physical activity

    12 months

  • fruit and vegetable intake

    12 months

  • Self-efficacy for physical activity

    12 months

  • Self-efficacy for fruit and vegetable intake

    12 months

Other Outcomes (1)

  • Church environment

    12 months

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Behavioral: Immediate Intervention

Delayed intervention

NO INTERVENTION

20 churches are followed but receive no intervention.

Interventions

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.

Also known as: Faith, Activity, and Nutrition
Immediate intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Members (phase 1): under the age of 18
  • Members (phase 1): does not regularly attend church participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clemson University

Clemson, South Carolina, 29634, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Fairfield Behavioral Health Services

Winnsboro, South Carolina, 29180, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseNutritional Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Sara J Wilcox, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

August 16, 2016

Study Start

January 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations