Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities

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.

Study Overview

• Status: Withdrawn
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Mighty Men Intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 77 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mighty Men Intervention; Mighty Men weight-loss intervention including health education and exercise during small group sessions	Behavioral: Mighty Men Intervention; 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.
NO_INTERVENTION: Comparison; Exercise-only small group sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Loss	The Primary outcome is change in weight loss at 6-months post-baseline.	6 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months post-baseline

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: American Cancer Society, Inc.
• Investigators: Principal Investigator: Derek Griffith, PhD, Vanderbilt University

Publications and helpful links

Helpful Links

• Mighty Men: A faith-based weight loss intervention to reduce cancer risk in African American men

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2017
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 191252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No