Faith-Based Initiative to Promote Health in Appalachia

Obesity Clinical Trial

Official title:

Appalachia Community Cancer Network II Centers for Reducing Cancer Disparities: Faith-Based Initiative to Promote Health in Appalachia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121691
• Other study ID #: 2012-085
• Secondary ID: NCI-2013-01400
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: June 15, 2017
• Start date: April 2013

Study information

• Verified date: June 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 669
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia
United States	Ohio State University	Columbus	Ohio
United States	Markey Cancer Center	Lexington	Kentucky
United States	West Virginia University	Morgantown	West Virginia
United States	Penn State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Mark Dignan, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index from baseline to one year follow-up		Baseline, month 12