Faith-Based Initiative to Promote Health in Appalachia

June 15, 2017 updated by: Mark Dignan, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

669

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Markey Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State University
    • Virginia
      • Blacksburg, Virginia, United States, 24061
        • Virginia Tech
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark Dignan, PhD

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-085
  • NCI-2013-01400 (Other Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe