Back to resultsFaith-Based Initiative to Promote Health in Appalachia
Primary Purpose
Cancer, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walk by Faith
Sponsored by
About this trial
This is an interventional prevention trial for Cancer focused on measuring Cancer, Obesity, Body Mass Index
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
Sites / Locations
- Markey Cancer Center
- Ohio State University
- Penn State University
- Virginia Tech
- West Virginia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Walk by Faith
Comparison
Arm Description
Intervention arm
Non-intervention arm
Outcomes
Primary Outcome Measures
Change in body mass index from baseline to one year follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02121691
Brief Title
Faith-Based Initiative to Promote Health in Appalachia
Official Title
Appalachia Community Cancer Network II Centers for Reducing Cancer Disparities: Faith-Based Initiative to Promote Health in Appalachia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark Dignan, PhD
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Obesity
Keywords
Cancer, Obesity, Body Mass Index
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
669 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walk by Faith
Arm Type
Experimental
Arm Description
Intervention arm
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Non-intervention arm
Intervention Type
Behavioral
Intervention Name(s)
Walk by Faith
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body mass index from baseline to one year follow-up
Time Frame
Baseline, month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Dignan, PhD, MPH
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Facility Name
Virginia Tech
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24061
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Faith-Based Initiative to Promote Health in Appalachia
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