Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

NCT ID: NCT03037502

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2021-03-31

Brief Summary

If the investigators are to adequately address the health needs of African American and Latino men, both culture and gender must be considered when developing and implementing strategies to encourage weight loss and increase their healthy eating and physical activity.The aim of this project is to develop and test gendered, culturally and contextually relevant messages that will be used in a future, web- based tailored intervention to encourage healthy eating and physical activity in African American and Latino men. This study is part of a larger research agenda that for a decade has focused on understanding and reducing chronic disease risk among African American and Latino men. Because men are more likely than women to engage in over 30 behaviors known to increase their risk of injury, morbidity, and mortality, improving men's health requires understanding the social and cultural factors that help explain sex differences in health. Operationalizing gender in individually-tailored health communications has great potential to unlock the potential of health communications and interventions to engage and improve the health of men and particularly African American and Latino men. To date, no community-based intervention has produced clinically significant improvements in weight loss, healthy eating or physical activity in Latino and African American men. It also is unclear how technology can be used to promote these behaviors in this population. Thus, there is a need to develop healthy eating, physical activity and weight loss interventions specifically targeted and tailored to African American and Latino men that explores the utility of technology. This intervention content and focus represents a novel strategy to promote health equity by using technology-based health care innovations to improve healthy eating and active living by addressing a root cause of unhealthy behavior in men: notions of manhood. The investigators focus on gender and manhood because they are under-explored factors that shape men's health behaviors.

Detailed Description

The overall aim of this study is to develop and pilot an individualized weight-loss intervention for obese middle-aged African American and Latino men and to explore how the genetically predicted BMI relates to outcomes. Using strategies previously employed by the PI to develop individually-tailored materials for African American men, the proposed study is designed to develop person-specific materials for Latino men (Specific Aim 1). Investigators also will pilot a behavioral weight loss intervention for 35-64 year old African American men in Nashville and Latino men in Miami (Specific Aims 2-3), and explore how the phenotypic expression of obesity shapes and is affected by behavioral and physiological changes (Specific Aim 4). The proposed intervention includes (a) person-specific goals/ messages (via web and text), (b) self-monitoring (via wearable device and text), (c) small group training and education (including social support) and (d) educational and community-based information and resources (via web and text).

Conditions

Weight Loss; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: Tailor Made

Intervention Arm: In the pilot intervention, participants will receive: tailored goals/ messages, self-monitoring, weekly small groups to receive health education and community-based information and resources. Participants will also complete two assessment with blood work and anthropometric measurements. These intervention components were selected based on investigator's formative research and experience using them in prior studies. These components will be implemented simultaneously as they complement one another. While all of these components have not been tested together in an intervention for this population, they are variations and enhancements of previous interventions by the investigators.

Group Type: EXPERIMENTAL

Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)

Intervention Type: BEHAVIORAL

Assess the effectiveness of a person-specific, randomized controlled pilot weight loss study of 80 African American and 40 Latino men; to compare changes in chronic disease risk behaviors (e.g., diet and physical activity), adiposity measures (e.g., body fat), and psychosocial mediators (e.g., social support, autonomous motivation) between data collected at baseline and at 3-months.

Comparison

Comparison Condition: Participants in the attention control group will receive self-help materials on how to improve healthy eating, physical activity and weight loss, self-monitoring, and complete two assessments with blood work and anthropometric measurements. Participants in this condition will receive a copy of their assessment data and the nurses will provide this personalized information as well as answer any questions participants may have about their assessment results.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)

Assess the effectiveness of a person-specific, randomized controlled pilot weight loss study of 80 African American and 40 Latino men; to compare changes in chronic disease risk behaviors (e.g., diet and physical activity), adiposity measures (e.g., body fat), and psychosocial mediators (e.g., social support, autonomous motivation) between data collected at baseline and at 3-months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: 35-64 at enrollment
• Race/ ethnicity: African American/ Black or Latino/ Hispanic
• BMI: 27-50
• Fluent in English (Nashville and Miami) or Spanish (Miami)
• Provide informed consent
• Weight less than 400 pounds

Exclusion Criteria

• Preexisting condition that prohibits at least moderate physical activity
• Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is contraindicated or that would cause weight loss
• Prior or planned 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 last 12 months

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

Meharry Medical College

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Derek Griffith

Director of the Center for Research on Men's Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily C Jaeger, MPH

Role: STUDY_DIRECTOR

Vanderbilt University

Derek M Griffith, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Natasha Solle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Neysari Arana, MPH

Role: STUDY_DIRECTOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

References

Griffith DM, Jaeger EC, Valdez LA, Schaefer Solle N, Garcia DO, Alexander LR. Developing a "Tailor-Made" Precision Lifestyle Medicine Intervention for Weight Control among Middle-aged Latino Men. Ethn Dis. 2020 Apr 2;30(Suppl 1):203-210. doi: 10.18865/ed.30.S1.203. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32269462 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1U54MD010722

Identifier Type: NIH

Identifier Source: secondary_id

View Link

160108

Identifier Type: -

Identifier Source: org_study_id

NCT04040335

Identifier Type: -

Identifier Source: nct_alias