NCT03082157

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 27, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

March 10, 2017

Last Update Submit

April 21, 2021

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    The Primary outcome is change in weight loss at 6-months post-baseline.

    6 months post-baseline

Secondary Outcomes (1)

  • Dietary patterns

    6 months post-baseline

Study Arms (2)

Mighty Men Intervention

EXPERIMENTAL

Mighty Men weight-loss intervention including health education and exercise during small group sessions

Behavioral: Mighty Men Intervention

Comparison

NO INTERVENTION

Exercise-only small group sessions

Interventions

Mighty Men InterventionBEHAVIORAL

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.

Mighty Men Intervention

Eligibility Criteria

Age35 Years - 77 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMost 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.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at enrollment
  • Black/African American
  • Male; Less than 400 pounds
  • BMI: 27-50
  • Fluent in english
  • provides informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Griffith DM, Pennings JS, Jaeger EC. Mighty Men: A Pilot Test of the Feasibility and Acceptability of a Faith-Based, Individually Tailored, Cluster-Randomized Weight Loss Trial for Middle-Aged and Older African American Men. Am J Mens Health. 2023 Jul-Aug;17(4):15579883231193235. doi: 10.1177/15579883231193235.

    PMID: 37608590DERIVED

Related Links

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Derek Griffith, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • Emily C Jaeger, MPH

    Vanderbilt University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 17, 2017

Study Start

October 27, 2017

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)