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

Not Applicable

Completed

• Conditions: Overweight; Obese; Weight Loss

• Registration Number: NCT02458053
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-29
• Study Start: 2016-02
• Primary Completion: 2016-12
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight	Baseline, 6 weeks, 12 weeks	Body weight(kg) expressed as a continuous variable will be collected on a digital scale.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States