Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
Primary Purpose
Weight Loss
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mighty Men Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- 35-77 at enrollment
- Black/African American
- Male; Less than 400 pounds
- BMI: 27-50
- Fluent in english
- provides informed consent
Exclusion Criteria:
- Pre-existing condition that prohibits at least moderate physical activity
- Serious medical condition that is likely to hinder accurate measurement of weight
- a condition for which weight loss is contraindicated
- a condition that would cause weight loss
- Prior (2 years) or planned (6 months) bariatric surgery
- Chronic use of medications that are likely to cause weight gain or cause weight loss
- No cell phone or land-line phone
- Participant in another obesity, eating or physical activity program or study
- Psychiatric hospitalization or in-patient substance abuse treatment in the past 12 months
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mighty Men Intervention
Comparison
Arm Description
Mighty Men weight-loss intervention including health education and exercise during small group sessions
Exercise-only small group sessions
Outcomes
Primary Outcome Measures
Weight Loss
The Primary outcome is change in weight loss at 6-months post-baseline.
Secondary Outcome Measures
Dietary patterns
Dietary patterns will be assessed using tools to measure fruit and vegetable intake and fat intake. Fruit and vegetable intake will be assessed using servings of fruits and vegetables consumed per day assessed with two brief frequency measures.
Full Information
NCT ID
NCT03082157
First Posted
March 10, 2017
Last Updated
April 21, 2021
Sponsor
Vanderbilt University
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03082157
Brief Title
Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
Official Title
Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Transfer of grant to new institution
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mighty Men is a 6-month faith-based weight-loss intervention for obese African American men 35-74 years old being conducted in Nashville, TN.
Detailed Description
Mighty Men is a 6-month faith-based weight-loss intervention for obese African American men 35-74 years old. The investigators will conduct this intervention in African American faith-based organizations because these organizations have the opportunity to consistently reach more African American men than any other institution in the African American community. African American faith-based organizations have historically served as a trusted institution for filling gaps in health and social services, including cancer prevention and control programs, within their natural role and function in the African American community. Additionally, African American faith-based organizations are important resources and sources of information for large numbers of middle-aged and older African American men, including those who are not members of a faith-based organization. Though African American men attend faith-based organization's at lower rates than African American women, men constitute 40% of the congregation membership among the largest denominations serving African Americans.
Mighty Men includes: (a) tailored goals/ messages, (b) self-monitoring, (c) small group training and education and (d) educational and community-based information and resources. There are three specific aims for the proposed study:
Specific Aim 1 is to compare the efficacy of Mighty Men to an attention control group in a cluster-randomized clinical trial of 448 African American men. The investigators hypothesize that men in faith-based organizations assigned to the intervention group will have lost more weight than men in faith-based organizations assigned to the comparison group at 6-months, and they will maintain greater weight loss than men in the control group 3-months post intervention.
Specific Aim 2 is to compare changes in cancer risk behaviors (e.g., healthy eating and physical activity), adiposity measures (e.g., body fat), and psychosocial mediators (e.g., perceived social support, autonomous motivation) at 6-months and 3-months post intervention between Mighty Men and comparison participants. The investigators hypothesize that men assigned to Mighty Men will demonstrate and maintain greater improvements in eating and physical activity and psychosocial mediators than those randomized to the attention control group.
Specific Aim 3 is to examine the impact of Mighty Men on the faith-based organizations that participate in the intervention. The investigators will conduct a rigorous process and impact evaluation to determine the extent of program reach, efficacy, adoption, implementation and maintenance (RE-AIM) in African American faith-based organizations in the intervention condition. Also, investigators hypothesize that faith-based organizations assigned to the intervention will demonstrate greater perceived efficacy to conduct and sustain health ministries for African American men and improvements in all areas of the RE-AIM framework than faith-based organizations randomized to the comparison group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a community based, cluster randomized, parallel group longitudinal trial. Each faith-based organization that meets inclusion criteria, agrees to participate and sign the memorandum of agreement will be matched on congregation size and randomized to either: 1) the exercise-only comparison group or 2) the Mighty Men weight-loss intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mighty Men Intervention
Arm Type
Experimental
Arm Description
Mighty Men weight-loss intervention including health education and exercise during small group sessions
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
Exercise-only small group sessions
Intervention Type
Behavioral
Intervention Name(s)
Mighty Men Intervention
Intervention Description
African American men assigned to this condition will receive: tailored goals/ messages, self-monitoring, small group meetings and educational and community-based information and resources.
Primary Outcome Measure Information:
Title
Weight Loss
Description
The Primary outcome is change in weight loss at 6-months post-baseline.
Time Frame
6 months post-baseline
Secondary Outcome Measure Information:
Title
Dietary patterns
Description
Dietary patterns will be assessed using tools to measure fruit and vegetable intake and fat intake. Fruit and vegetable intake will be assessed using servings of fruits and vegetables consumed per day assessed with two brief frequency measures.
Time Frame
6 months post-baseline
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Most weight loss, healthy eating and physical activity interventions for African Americans have included considerably more African American women than African American men. One of the most crucial challenges in behavioral interventions has been reaching African American men and identifying settings where interventions are sustainable over time. In the past 25 years, no community-based intervention has produced clinically significant changes in weight loss, eating practices or physical activity in African American men. The investigators propose to develop and test the first individually-tailored, weight loss intervention for African American men.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
35-77 at enrollment
Black/African American
Male; Less than 400 pounds
BMI: 27-50
Fluent in english
provides informed consent
Exclusion Criteria:
Pre-existing condition that prohibits at least moderate physical activity
Serious medical condition that is likely to hinder accurate measurement of weight
a condition for which weight loss is contraindicated
a condition that would cause weight loss
Prior (2 years) or planned (6 months) bariatric surgery
Chronic use of medications that are likely to cause weight gain or cause weight loss
No cell phone or land-line phone
Participant in another obesity, eating or physical activity program or study
Psychiatric hospitalization or in-patient substance abuse treatment in the past 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Griffith, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emily C Jaeger, MPH
Organizational Affiliation
Vanderbilt University
Official's Role
Study Director
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://books.google.com/books?hl=en&lr=&id=zHzZDwAAQBAJ&oi=fnd&pg=PA189&dq=Mighty+Men:+A+Faith-based+Weight+Loss+Intervention+to+Reduce+Cancer+Risk+in+African+American+Men&ots=8TD3aUOpxz&sig=9_hjRbAfu_PEMUgw_tGvKJCYN50#v=onepage&q=Mighty%20Men%3A%20A%20Faith-based%20Weight%20Loss%20Intervention%20to%20Reduce%20Cancer%20Risk%20in%20African%20American%20Men&f=false
Description
Mighty Men: A faith-based weight loss intervention to reduce cancer risk in African American men
Learn more about this trial
Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
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