Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

Obesity Clinical Trial

Official title:

Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037502
• Other study ID #: 160108
• Secondary ID: 1U54MD010722
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT04040335

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (5)

Lead Sponsor	Collaborator
Vanderbilt University	Meharry Medical College, National Institute on Minority Health and Health Disparities (NIMHD), University of Miami, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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