Weight LossNCT03082157
Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
A study testing Mighty Men Intervention in people with Weight Loss, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 77 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Mighty Men Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2017to 30 Jun 2021
- 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 35 to 77 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 35-77 at enrollment
- Black/African American
- Male; Less than 400 pounds
- BMI: 27-50
- Fluent in english
- provides informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Weight Loss
- Being tested
- Mighty Men Intervention
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mighty Men InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mighty Men Intervention | Experimental | Mighty Men weight-loss intervention including health education and exercise during small group sessions Receives: Behavioral: Mighty Men Intervention |
| Comparison | No intervention | Exercise-only small group sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
The Primary outcome is change in weight loss at 6-months post-baseline.
Measured: 6 months post-baseline
Secondary outcomes (1)
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.
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start27 Oct 2017
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Why it stopped: Transfer of grant to new institution
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 Weight LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Derek Griffith, Vanderbilt University
- Investigators
- Derek Griffith, PhD, Principal investigator, Vanderbilt UniversityEmily C Jaeger, MPH, Study director, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082157
- Sponsor's protocol ID
- 191252
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2017
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37608590
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
- ClinicalTrials.gov ID
- NCT03082157
- Acronym / sponsor ID
- 191252
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Transfer of grant to new institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 17 Mar 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Mighty Men Intervention | Experimental | Behavioral: Mighty Men InterventionMighty Men weight-loss intervention including health education and exercise during small group sessions |
| Comparison | No intervention | –Exercise-only small group sessions |
Who may qualify
- Ages
- 35 to 77 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 35-77 at enrollment
- Black/African American
- Male; Less than 400 pounds
- BMI: 27-50
- Fluent in english
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Mighty Men InterventionAfrican American men assigned to this condition will receive: tailored goals/ messages, self-monitoring, small group meetings and educational and community-based information and resources. | Behavioural | Mighty Men Intervention |
Primary outcome
Weight Loss
Time frame: 6 months post-baseline
The Primary outcome is change in weight loss at 6-months post-baseline.
1 secondary outcome
Dietary patterns
Time frame: 6 months post-baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Derived from this study: PubMed 37608590Griffith 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.
- Mighty Men: A faith-based weight loss intervention to reduce cancer risk in African American menLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Derek Griffith, PhD principal investigator
Vanderbilt University
Emily C Jaeger, MPH study director
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mighty Men Intervention in people with Weight Loss, run by Vanderbilt University at 1 site 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Weight Loss (time frame: 6 months post-baseline). 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 NCT03082157, 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 23 Apr 2021.