Faith-Based Initiative to Promote Health in Appalachia | NCT02121691

Studies
Faith-Based Initiative to Promote Health in Appalachia

NCT02121691

Sponsor

Mark Dignan, PhD

Status

Completed

Last Update Posted

Jun 16, 2017Actual

Enrollment

669Actual

Phase

Not Applicable

Conditions

Cancer
Obesity

Interventions

Walk by Faith

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2013-01400	Other Identifier	NCI CTRP

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Not provided

First Submitted Date

Apr 18, 2014

First Submission Date that Met QC Criteria

Apr 22, 2014

First Posted Date

Apr 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2017

Last Update Posted Date

Jun 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The project will target two behavioral causes of obesity: a sedentary lifestyle and an unhealthy diet. The goal is to test a faith-based intervention among men and women who are members of participating Appalachian churches.

The primary hypothesis being tested in this project is: The change in body mass index from baseline to one year follow-up in intervention churches will be greater than among comparison churches, such that the differential change will be negative on average.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

669Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Walk by Faith	Experimental	Intervention arm	Behavioral: Walk by Faith
Comparison	No Intervention	Non-intervention arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Walk by Faith	Behavioral	The Walk by Faith program is aimed at increasing physical activity and improving healthy eating to reduce or maintain healthy BMI among members of the churches.

Measure	Description	Time Frame
Change in body mass index from baseline to one year follow-up		Baseline, month 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older
Member of the participating church who has attended services at least 4 times in the past 2 months
resident of an Appalachia county
Able bodied (no contraindications to physical activity and no dietary restrictions that are part of a medically prescribed diet for weight loss or formal weight loss program)
Able to read and write in English
Have a BMI indicating that they are overweight (BMI > or = 25.0, assessed during biometric measurement)
Under 400 pounds (per self-report and confirmed during biometric measurement)
Not planning to move out of the area within the next year
Does not reside in nursing facility or residential home
If female, is not pregnant, breastfeeding or less than 9 months post-partum and does not intend to become pregnant during the study
Able to provide informed consent.

Exclusion Criteria:

Does not meet Inclusion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Dignan, PhD, MPH	Lucille P. Markey Cancer Center at University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Markey Cancer Center		Lexington	Kentucky	40536	United States
Ohio State University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39924605	Derived	Zhang X, Shoben A, Felix AS, Focht BC, Baltic RD, Paskett ED. The mediating role of social support in behavioral changes and weight loss outcomes among overweight Appalachian adults. J Behav Med. 2025 Apr;48(2):360-372. doi: 10.1007/s10865-025-00555-0. Epub 2025 Feb 9.

ID	Term
D009369	Neoplasms
D009765	Obesity

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases