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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Weight Loss
Obese
Overweight

Treatments

Behavioral: Face to face group sessions
Behavioral: Feedback
Behavioral: Self Monitor
Other: Notebook
Behavioral: Couples Skill Training
Behavioral: Attends with partner

Study type

Interventional

Funder types

Other

Identifiers

NCT02458053
14-3193

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

TEAM Enhanced
Experimental group
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.
Treatment:
Behavioral: Feedback
Behavioral: Self Monitor
Behavioral: Face to face group sessions
Behavioral: Couples Skill Training
Behavioral: Attends with partner
Other: Notebook
TEAM Traditional
Active Comparator group
Description:
The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.
Treatment:
Behavioral: Feedback
Behavioral: Self Monitor
Behavioral: Face to face group sessions
Other: Notebook

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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