Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT03037502

Collaborator

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

Enrollment

Locations

Arms

21.6

Actual Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Obesity	Behavioral: Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

Actual Study Start Date :

Jun 12, 2019

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in weight at 3-months post-baseline [3-months post-baseline of participation]
Investigators will report weight change in absolute terms from baseline.

Secondary Outcome Measures

Percent change in weight at 3-months post-baseline [3-months post-baseline of participation]
Investigators will report weight change as percent change from baseline.
Change in weight classification [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 Outcome Measures

Change in eating practices measured by the Food, Attitudes, and Behaviors Survey (FAB) [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.
Change in physical activity measured by the Global Physical Activity Questionnaire (GPAQ) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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