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 : April 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss Obesity||Behavioral: Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Derek M Griffith, PhDfirstname.lastname@example.org|
|Contact: Emily C Jaeger, MPHemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Neysari Arana|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Contact: Emily Jaeger, MPH|
|Study Director:||Emily C Jaeger, MPH||Vanderbilt University|
|Principal Investigator:||Derek M Griffith, PhD||Vanderbilt University|
|Principal Investigator:||Natasha Solle, PhD||University of Miami|
|Study Director:||Neysari Arana, MPH||University of Miami|