Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Behavioral: Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)

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).

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight at 3-months post-baseline	Investigators will report weight change in absolute terms from baseline.	3-months post-baseline of participation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in weight at 3-months post-baseline	Investigators will report weight change as percent change from baseline.	3-months post-baseline of participation
Change in weight classification	Investigators will assess change in percentage of participants that regress from obese to overweight classification using BMI in kg/m^2.	3-months post baseline of participation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eating practices measured by the Food, Attitudes, and Behaviors Survey (FAB)	As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, to measure the change in fruit and vegetable intake (FVI) during the past month. Responses will be converted into servings, as defined by the MyPyramid 1992 dietary guidelines. Total FVI was calculated as the sum of all items on the screener, excluding fried potatoes.	3-months post baseline of participation
Change in physical activity measured by the Global Physical Activity Questionnaire (GPAQ)	The GPAQ measures time spent in vigorous and moderate intensity physical activity. A higher score equates to more physical activity. The range is from 0 - 150 minutes per week.	3-months post baseline of participation

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: University of Miami; National Institute on Minority Health and Health Disparities (NIMHD); Vanderbilt University Medical Center; Meharry Medical College
• Investigators: Principal Investigator: Derek M Griffith, PhD, Vanderbilt University; Principal Investigator: Natasha Solle, PhD, University of Miami; Study Director: Neysari Arana, MPH, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: weight loss; Men's Health; African American men; Latino men
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 160108; 1U54MD010722 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No