Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

NCT03037502 | Completed

• 2 other identifiers: 1601081U54MD010722
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Weight Loss; Obesity

Keywords

Men's Health; weight loss; African American men; Latino men

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent change in weight at 3-months post-baseline

  3-months post-baseline of participation

• Change in weight classification

  3-months post baseline of participation

Other Outcomes (2)

• Change in eating practices measured by the Food, Attitudes, and Behaviors Survey (FAB)

  3-months post baseline of participation

• Change in physical activity measured by the Global Physical Activity Questionnaire (GPAQ)

  3-months post baseline of participation

Study Arms (2)

Intervention: Tailor Made

EXPERIMENTAL

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)

Comparison

NO INTERVENTION

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.

Interventions

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

Intervention: Tailor Made

Eligibility Criteria

• Age: 35 Years - 64 Years
• Gender Eligibility Details: This study is interested in piloting a tailored health promoting intervention for African American and Latino men. Thus, recruitment will be open to individuals who self-identify as African American or Latino men, ages 35-64 at enrollment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• University of Miami: collaborator
• Vanderbilt University Medical Center: collaborator
• Meharry Medical College: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• 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.

  PMID: 32269462 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Emily C Jaeger, MPH

  Vanderbilt University

  STUDY DIRECTOR

• Derek M Griffith, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Natasha Solle, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Neysari Arana, MPH

  University of Miami

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Research on Men's Health

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 31, 2017
• Study Start: June 12, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)