Clinical trial NCT02868866: Dissemination and Implementation of Faith, Activity, and Nutrition
Official title: Faith, Activity, and Nutrition: Dissemination in Underserved Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity, Healthy Eating
Keywords: physical activity
nutrition
fruits and vegetables
faith-based
churches
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 1807
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Adoption
timeFrame: 12 months
measure: Reach
timeFrame: 12 months
measure: Implementation fidelity
timeFrame: 12 months
measure: Maintenance
timeFrame: 24 months
Secondary outcomes:
measure: physical activity
timeFrame: 12 months
measure: fruit and vegetable intake
timeFrame: 12 months
measure: Self-efficacy for physical activity
timeFrame: 12 months
measure: Self-efficacy for fruit and vegetable intake
timeFrame: 12 months
Other outcomes:
measure: Church environment
timeFrame: 12 months
Locations:
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
city: Winnsboro
country: United States
facility: Fairfield Behavioral Health Services
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Sara J Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.