CancerNCT02121691
Faith-Based Initiative to Promote Health in Appalachia
A study testing Walk by Faith in people with Cancer and Obesity, run by Mark Dignan, PhD at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Walk by Faith
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 669 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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.
Who cannot join
- Does not meet Inclusion criteria
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Virginia Tech
Blacksburg, Virginia, 24061
Ohio State University
Columbus, Ohio, 43210
Markey Cancer Center
Lexington, Kentucky, 40536
West Virginia University
Morgantown, West Virginia, 26506
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: 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.
- Being tested
- Walk by Faith
- Keywords
- Cancer, Obesity, Body Mass Index
- Medical subject headings
- Neoplasms, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk by FaithBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Walk by Faith | Experimental | Intervention arm Receives: Behavioral: Walk by Faith |
| Comparison | No intervention | Non-intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index from baseline to one year follow-up
Measured: Baseline, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Dignan, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Dignan, PhD, University of Kentucky
- Investigators
- Mark Dignan, PhD, MPH, Principal investigator, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121691
- Sponsor's protocol ID
- 2012-085
- Other IDs
- NCI-2013-01400
- Status last verified
- Jun 2017
- First submitted
- 18 Apr 2014
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39924605
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appalachia Community Cancer Network II Centers for Reducing Cancer Disparities: Faith-Based Initiative to Promote Health in Appalachia
- ClinicalTrials.gov ID
- NCT02121691
- Acronym / sponsor ID
- 2012-085
- Keywords
- Cancer, Obesity, Body Mass Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Mark Dignan, PhDUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk by Faith | Experimental | Behavioral: Walk by FaithIntervention arm |
| Comparison | No intervention | –Non-intervention arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- Does not meet Inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk by FaithThe 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. | Behavioural | Walk by Faith |
Primary outcome
Change in body mass index from baseline to one year follow-up
Time frame: Baseline, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Derived from this study: PubMed 39924605Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Dignan, PhD, MPH principal investigator
Lucille P. Markey Cancer Center at University of Kentucky
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk by Faith in people with Cancer and Obesity, run by Mark Dignan, PhD at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index from baseline to one year follow-up (time frame: Baseline, month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.