Clinical trial NCT03082157: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-03-17
Enrollment: 0
Sex: MALE
Minimum age (years): 35
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight Loss
timeFrame: 6 months post-baseline
Secondary outcomes:
measure: Dietary patterns
timeFrame: 6 months post-baseline
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Derek Griffith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Emily C Jaeger, MPH
role: STUDY_DIRECTOR
References: