Testing the Efficacy of a Spousal Support Enhanced Weight Loss Program on Weight Loss Among African American Men (TEAM)

September 13, 2017 updated by: University of North Carolina, Chapel Hill
The purpose of this study is to determine the effect of a spousal support enhanced weight loss program on weight loss among African American men.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In 2012, African Americans (AA) were 1.4 times more likely to be overweight and obese than non-Hispanic Whites. The Office of Minority Health reports the prevalence of overweight and obesity (BMI>25) among AA men age 20 and older is 70%. AA men suffer disproportionately from obesity-related consequences. Modest weight loss (WL) of 10% or less improves cardiovascular disease risk factors and reduces the risk of type 2 diabetes. However, the majority of participants in lifestyle weight loss (LWL) interventions are most commonly Caucasian women. While men are unrepresented in weight loss programs; even fewer studies examine WL in AA men. Only 4.5% of AA men participate in research studies, according to the National Institute of Health (NIH). When AA men have participated in LWL interventions, they have loss less weight compared to Caucasian men. Consequently, the evidence on the appropriateness of the current WL strategies and recommendations for AA men is limited.

There is limited literature on the appropriate strategies for WL in AA men because of their lack of participation. Social support is a predictor of weight loss and support from family is important in AA culture. Spousal support results, defined as spouse or significant other, are inconsistent and are largely conducted in Caucasian populations. The use of individual based theoretical frameworks may explain these inconsistencies. Using a dyad based framework like the Interdependence Theory may produce different results. The use of a dyad based theoretical framework and testing the effects of spousal support adds to the literature of WL among AA men.

This study seeks to determine the best strategies to attract overweight and obese AA men to participate and examine the efficacy of a 3 month spousal support enhanced behavioral weight loss intervention focused on behavior modification, nutrition and physical activity compared to a traditional intervention in achieving clinical significant weight loss in AA men. Using 2 arms randomized controlled trial (RCT) 26 AA men and their partners will be recruited to participate in each arm in Orange, Durham and Wake County, North Carolina. The investigator hypothesizes the proposed TEAM (Together Eating & Activity Matters) program, a spousal support enhanced WL intervention, will result in clinical weight loss among AA men.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The participant self-identifies as African American male.
  • The participant is between the ages of 18 and 65.
  • The participant has a BMI between 25 and 45 kg/m2.
  • The participant enrolls with an African American overweight female spouse or cohabiting intimate partner
  • The participant has weekly access to the internet and/or a mobile phone with internet capabilities.

Exclusion Criteria:

  • Both the participant and the partner are not willing and interested in losing weight.
  • The participant is taking any medications that affect weight.
  • The participant is participating in any other weight loss program.
  • The participant has recently lost 10 lbs or more.
  • The participant is expecting to relocate within the next 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEAM Enhanced
The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.
Behavioral: Attends with partner
The index partner will participate in intervention as a couple with their female counterpart.
Behavioral: Couples Skill Training
Participants and their partners will attend a pre session covering topics to assist them in working together to facilitate lifestyle changes.
Behavioral: Face to face group sessions
Group sessions will consists of components in traditional weight management programs.
Behavioral: Self Monitor
Participants will be instructed to monitor their eating and physical activity behaviors online/mobile application.
Other: Notebook
The notebook will consist of behavioral lessons, diet and physical activity plans, and additional resources to assist participants in achieving their behavioral goals.
Behavioral: Feedback
Each participant will receive a tailored email providing feedback on their weekly progress.
Active Comparator: TEAM Traditional
The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.
Behavioral: Face to face group sessions
Group sessions will consists of components in traditional weight management programs.
Behavioral: Self Monitor
Participants will be instructed to monitor their eating and physical activity behaviors online/mobile application.
Other: Notebook
The notebook will consist of behavioral lessons, diet and physical activity plans, and additional resources to assist participants in achieving their behavioral goals.
Behavioral: Feedback
Each participant will receive a tailored email providing feedback on their weekly progress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline, 6 weeks, 12 weeks
Body weight(kg) expressed as a continuous variable will be collected on a digital scale.
Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist Circumference
Time Frame: Baseline,12 weeks
Baseline,12 weeks
BMI
Time Frame: Baseline,12 weeks
Baseline,12 weeks
Blood pressure
Time Frame: Baseline, 12 weeks
Blood pressure will be assessed using DINAMAP monitor.
Baseline, 12 weeks
Behavior
Time Frame: Baseline, 12 weeks
Changes in behavior will be assessed (e.g. diet (caloric Intake), and physical activity).
Baseline, 12 weeks
Psychosocial variables
Time Frame: Baseline, 12 weeks
Changes in psychosocial variables will be assessed (Self-regulation of eating behaviors, self-efficacy of eating behaviors and physical activity).
Baseline, 12 weeks
Social Support
Time Frame: Baseline, 6 weeks, 12 weeks
Social support of eating behaviors and physical activity will be assessed.
Baseline, 6 weeks, 12 weeks
Couple/Family Variables
Time Frame: Baseline, 12 weeks
Couple/ Family Variables will be assessed (e.g. marital satisfaction, transformation of motivation/communal coping, and family communication).
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Study Chair: Deborah F Tate, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Candice Alick, MS, University of NC-Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-3193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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