Physical Activity, Healthy EatingNCT02868866
Dissemination and Implementation of Faith, Activity, and Nutrition
A study testing Immediate Intervention in people with Physical Activity, Healthy Eating, run by University of South Carolina at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Healthy Eating
- What is being tested?
- Immediate Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,807 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Members (phase 1): under the age of 18
- Members (phase 1): does not regularly attend church participating in the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clemson University
Clemson, South Carolina, 29634
University of South Carolina
Columbia, South Carolina, 29208
Fairfield Behavioral Health Services
Winnsboro, South Carolina, 29180
About this study
Official title: 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.
Read the 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).
- Conditions
- Physical Activity, Healthy Eating
- Being tested
- Immediate Intervention
- Keywords
- physical activity, nutrition, fruits and vegetables, faith-based, churches
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate InterventionBehavioural
Also called Faith, Activity, and Nutrition
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Training of church committee followed by 12 months of technical assistance phone calls. Receives: Behavioral: Immediate Intervention |
| Delayed intervention | No intervention | 20 churches are followed but receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption
(# of eligible churches that are trained / # of eligible churches)*100
Measured: 12 months
Reach
(# of church members in trained churches / # of members of all eligible churches)*100
Measured: 12 months
Implementation fidelity
Composite score consisting of implementation of core elements of the intervention
Measured: 12 months
Maintenance
organization maintenance of the intervention based on leader reports
Measured: 24 months
Secondary outcomes (4)
physical activity
Self-reported proportion of members meeting physical activity recommendations using (only for phase 1 of study)
Measured: 12 months
fruit and vegetable intake
Self-reported cups per day of fruits and vegetables (only for phase 1 of study)
Measured: 12 months
Self-efficacy for physical activity
Self-reported self-efficacy for physical activity (average of scale items) (only for phase 1 of study)
Measured: 12 months
Self-efficacy for fruit and vegetable intake
Self-reported self-efficacy for fruit and vegetable intake (average of scale items) (only for phase 1 of study)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical Activity, Healthy EatingStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,807 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Wilcox, University of South Carolina
- Investigators
- Sara J Wilcox, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868866
- Sponsor's protocol ID
- Pro00036222
- Status last verified
- Apr 2021
- First submitted
- 12 Jul 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 35236373Wilcox 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.
PubMed 32528919Wilcox 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.
PubMed 29656913
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faith, Activity, and Nutrition: Dissemination in Underserved Communities
- ClinicalTrials.gov ID
- NCT02868866
- Acronym / sponsor ID
- Pro00036222
- Conditions
- Physical Activity, Healthy Eating
- Keywords
- physical activity, nutrition, fruits and vegetables, faith-based, churches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,807 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Behavioral: Immediate InterventionTraining of church committee followed by 12 months of technical assistance phone calls. |
| Delayed intervention | No intervention | –20 churches are followed but receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Members (phase 1): under the age of 18
- Members (phase 1): does not regularly attend church participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate InterventionAlso: Faith, Activity, and NutritionCommittees 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. | Behavioural | Immediate intervention |
Primary outcome
Adoption
Time frame: 12 months
(# of eligible churches that are trained / # of eligible churches)*100
Reach
Time frame: 12 months
(# of church members in trained churches / # of members of all eligible churches)*100
Implementation fidelity
Time frame: 12 months
Composite score consisting of implementation of core elements of the intervention
Maintenance
Time frame: 24 months
organization maintenance of the intervention based on leader reports
4 secondary outcomes
physical activity
Time frame: 12 months
fruit and vegetable intake
Time frame: 12 months
Self-efficacy for physical activity
Time frame: 12 months
Self-efficacy for fruit and vegetable intake
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 35236373Wilcox 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.
- Derived from this study: PubMed 32528919Wilcox 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.
- Derived from this study: PubMed 29656913Wilcox 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara J Wilcox, PhD principal investigator
University of South Carolina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Intervention in people with Physical Activity, Healthy Eating, run by University of South Carolina at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868866, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.