Clinical trial NCT03037502: Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men
Official title: Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Keywords: Men's Health
weight loss
African American men
Latino men
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: Vanderbilt University Medical Center
name: Meharry Medical College
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2017-01-31
Enrollment: 72
Sex: MALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in weight at 3-months post-baseline
timeFrame: 3-months post-baseline of participation
Secondary outcomes:
measure: Percent change in weight at 3-months post-baseline
timeFrame: 3-months post-baseline of participation
measure: Change in weight classification
timeFrame: 3-months post baseline of participation
Other outcomes:
measure: Change in eating practices measured by the Food, Attitudes, and Behaviors Survey (FAB)
timeFrame: 3-months post baseline of participation
measure: Change in physical activity measured by the Global Physical Activity Questionnaire (GPAQ)
timeFrame: 3-months post baseline of participation
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Emily C Jaeger, MPH
role: STUDY_DIRECTOR
affiliation: Vanderbilt University
name: Derek M Griffith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Natasha Solle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Neysari Arana, MPH
role: STUDY_DIRECTOR
References:
citation: 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.