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Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

Primary Purpose

Weight Loss, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Men's Health, weight loss, African American men, Latino men

Eligibility Criteria

35 Years - 64 Years (Adult)MaleDoes not accept 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

Sites / Locations

  • University of Miami
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention: Tailor Made

Comparison

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percent change in weight at 3-months post-baseline
Investigators will report weight change as percent change from baseline.
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.

Full Information

First Posted
January 26, 2017
Last Updated
April 21, 2021
Sponsor
Vanderbilt University
Collaborators
University of Miami, Vanderbilt University Medical Center, Meharry Medical College, National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03037502
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
University of Miami, Vanderbilt University Medical Center, Meharry Medical College, National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Obesity
Keywords
Men's Health, weight loss, African American men, Latino men

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Tailor Made
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)
Intervention Description
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 Outcome Measure Information:
Title
Change in weight at 3-months post-baseline
Description
Investigators will report weight change in absolute terms from baseline.
Time Frame
3-months post-baseline of participation
Secondary Outcome Measure Information:
Title
Percent change in weight at 3-months post-baseline
Description
Investigators will report weight change as percent change from baseline.
Time Frame
3-months post-baseline of participation
Title
Change in weight classification
Description
Investigators will assess change in percentage of participants that regress from obese to overweight classification using BMI in kg/m^2.
Time Frame
3-months post baseline of participation
Other Pre-specified Outcome Measures:
Title
Change in eating practices measured by the Food, Attitudes, and Behaviors Survey (FAB)
Description
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.
Time Frame
3-months post baseline of participation
Title
Change in physical activity measured by the Global Physical Activity Questionnaire (GPAQ)
Description
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.
Time Frame
3-months post baseline of participation

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily C Jaeger, MPH
Organizational Affiliation
Vanderbilt University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Derek M Griffith, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natasha Solle, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neysari Arana, MPH
Organizational Affiliation
University of Miami
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32269462
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.
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Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

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