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Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

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ClinicalTrials.gov Identifier: NCT03037502
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Derek Griffith, Vanderbilt University

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 increase their healthy eating and physical activity and decrease tobacco use.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 tobacco cessation and increase healthy eating and physical activity in African American 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 Behavioral: Intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 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 : June 12, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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: Intervention
Assess the effectiveness of a person-specific, randomized controlled pilot weight loss study of 120 African American and 120 Latino men; to compare changes in HbA1c, diabetes 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 6-months

No Intervention: Control
Control 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 35-64 at enrollment
  • Race/ ethnicity: African American/ Black or Latino/ Hispanic
  • BMI: 30-50
  • 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 in the last 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037502


Contacts
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Contact: Derek M Griffith, PhD 615-322-0648 derek.griffith@vanderbilt.edu
Contact: Emily C Jaeger, MPH 615-875-8478 emily.k.cornish@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37203
Contact: Emily Jaeger, MPH         
Sponsors and Collaborators
Vanderbilt University
Investigators
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Study Director: Emily C Jaeger, MPH Vanderbilt University
Principal Investigator: Derek M Griffith, PhD Vanderbilt University

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Responsible Party: Derek Griffith, Director of the Center for Research on Men's Health, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03037502     History of Changes
Other Study ID Numbers: 160108
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Derek Griffith, Vanderbilt University:
Men's Health
weight loss
African American men
Latino men

Additional relevant MeSH terms:
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Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes