Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-02 @ 9:47 AM
Study NCT ID:
NCT03082157
Status:
WITHDRAWN
Last Update Posted:
2021-04-23
First Post:
2017-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
Mighty Men Nashville: A Faith-Based Weight Loss Program to Address Cancer Disparities
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Transfer of grant to new institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: