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Completed

NCT Number: NCT03037502

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.

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Key information

Age range

35 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami, Miami, Florida, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in weight at 3-months post-baseline

    Time frame: 3-months post-baseline of participation

    Investigators will report weight change in absolute terms from baseline.

Secondary outcomes

  1. Percent change in weight at 3-months post-baseline

    Time frame: 3-months post-baseline of participation

    Investigators will report weight change as percent change from baseline.

  2. Change in weight classification

    Time frame: 3-months post baseline of participation

    Investigators will assess change in percentage of participants that regress from obese to overweight classification using BMI in kg/m^2.

Other outcomes

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

    Time frame: 3-months post baseline of participation

    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.

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

    Time frame: 3-months post baseline of participation

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2017
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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