Faith-Based Initiative to Promote Health in Appalachia

• Sponsor: Mark Dignan, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT02121691
• Collaborator: (none)
• Enrollment: 669
• Locations: 5
• Arms: 2
• Patients Per Site: 133.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Obesity	Behavioral: Walk by Faith	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 669 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Appalachia Community Cancer Network II Centers for Reducing Cancer Disparities: Faith-Based Initiative to Promote Health in Appalachia
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Walk by Faith Intervention arm	Behavioral: Walk by Faith; 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.
No Intervention: Comparison Non-intervention arm

Outcome Measures

Primary Outcome Measures

1. Change in body mass index from baseline to one year follow-up [Baseline, month 12]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Markey Cancer Center	Lexington	Kentucky	United States	40536
2	Ohio State University	Columbus	Ohio	United States	43210
3	Penn State University	University Park	Pennsylvania	United States	16802
4	Virginia Tech	Blacksburg	Virginia	United States	24061
5	West Virginia University	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• Mark Dignan, PhD

Investigators

• Principal Investigator: Mark Dignan, PhD, MPH, Lucille P. Markey Cancer Center at University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Dignan, PhD, Principal Investigator, University of Kentucky
• ClinicalTrials.gov Identifier: NCT02121691
• Other Study ID Numbers: 2012-085; NCI-2013-01400
• First Posted: Apr 23, 2014
• Last Update Posted: Jun 16, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Mark Dignan, PhD, Principal Investigator, University of Kentucky: Cancer; Obesity; Body Mass Index
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Jun 16, 2017