NCT02121691

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
669

participants targeted

Target at P75+ for not_applicable cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

April 18, 2014

Last Update Submit

June 15, 2017

Conditions

CancerObesity

Keywords

CancerObesityBody Mass Index

Outcome Measures

Primary Outcomes (1)

  • Change in body mass index from baseline to one year follow-up

    Baseline, month 12

Study Arms (2)

Walk by Faith

EXPERIMENTAL

Intervention arm

Behavioral: Walk by Faith

Comparison

NO INTERVENTION

Non-intervention arm

Interventions

Walk by FaithBEHAVIORAL

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.

Walk by Faith

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

  • 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.

    PMID: 39924605DERIVED

MeSH Terms

Conditions

NeoplasmsObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Dignan, PhD, MPH

    Lucille P. Markey Cancer Center at University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2014

First Posted

April 23, 2014

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

US(5)