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

Primary Purpose

Overweight, Weight Loss, Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attends with partner
Couples Skill Training
Face to face group sessions
Self Monitor
Notebook
Feedback
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring African American, male, couples, randomized control trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TEAM Enhanced

TEAM Traditional

Arm Description

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.

The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.

Outcomes

Primary Outcome Measures

Weight
Body weight(kg) expressed as a continuous variable will be collected on a digital scale.

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2015
Last Updated
September 13, 2017
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT02458053
Brief Title
Testing the Efficacy of a Spousal Support Enhanced Weight Loss Program on Weight Loss Among African American Men
Acronym
TEAM
Official Title
Testing the Efficacy of a Spousal Support Enhanced Weight Loss Program on Weight Loss Among African American Men
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Weight Loss, Obese
Keywords
African American, male, couples, randomized control trial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TEAM Enhanced
Arm Type
Experimental
Arm Description
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.
Arm Title
TEAM Traditional
Arm Type
Active Comparator
Arm Description
The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.
Intervention Type
Behavioral
Intervention Name(s)
Attends with partner
Intervention Description
The index partner will participate in intervention as a couple with their female counterpart.
Intervention Type
Behavioral
Intervention Name(s)
Couples Skill Training
Intervention Description
Participants and their partners will attend a pre session covering topics to assist them in working together to facilitate lifestyle changes.
Intervention Type
Behavioral
Intervention Name(s)
Face to face group sessions
Intervention Description
Group sessions will consists of components in traditional weight management programs.
Intervention Type
Behavioral
Intervention Name(s)
Self Monitor
Intervention Description
Participants will be instructed to monitor their eating and physical activity behaviors online/mobile application.
Intervention Type
Other
Intervention Name(s)
Notebook
Intervention Description
The notebook will consist of behavioral lessons, diet and physical activity plans, and additional resources to assist participants in achieving their behavioral goals.
Intervention Type
Behavioral
Intervention Name(s)
Feedback
Intervention Description
Each participant will receive a tailored email providing feedback on their weekly progress.
Primary Outcome Measure Information:
Title
Weight
Description
Body weight(kg) expressed as a continuous variable will be collected on a digital scale.
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Waist Circumference
Time Frame
Baseline,12 weeks
Title
BMI
Time Frame
Baseline,12 weeks
Title
Blood pressure
Description
Blood pressure will be assessed using DINAMAP monitor.
Time Frame
Baseline, 12 weeks
Title
Behavior
Description
Changes in behavior will be assessed (e.g. diet (caloric Intake), and physical activity).
Time Frame
Baseline, 12 weeks
Title
Psychosocial variables
Description
Changes in psychosocial variables will be assessed (Self-regulation of eating behaviors, self-efficacy of eating behaviors and physical activity).
Time Frame
Baseline, 12 weeks
Title
Social Support
Description
Social support of eating behaviors and physical activity will be assessed.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Couple/Family Variables
Description
Couple/ Family Variables will be assessed (e.g. marital satisfaction, transformation of motivation/communal coping, and family communication).
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah F Tate, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Candice Alick, MS
Organizational Affiliation
University of NC-Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29479466
Citation
Alick CL, Samuel-Hodge C, Ward D, Ammerman A, Rini C, Tate DF. Together Eating & Activity Matters (TEAM): results of a pilot randomized-clinical trial of a spousal support weight loss intervention for Black men. Obes Sci Pract. 2018 Jan 17;4(1):62-75. doi: 10.1002/osp4.142. eCollection 2018 Feb.
Results Reference
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Testing the Efficacy of a Spousal Support Enhanced Weight Loss Program on Weight Loss Among African American Men

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