Clinical trial NCT02458053: Testing the Efficacy of a Spousal Support Enhanced Weight Loss Program on Weight Loss Among African American Men
Official title: Testing the Efficacy of a Spousal Support Enhanced Weight Loss Program on Weight Loss Among African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Weight Loss
Obese
Keywords: African American
male
couples
randomized control trial
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Weight
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Waist Circumference
timeFrame: Baseline,12 weeks
measure: BMI
timeFrame: Baseline,12 weeks
measure: Blood pressure
timeFrame: Baseline, 12 weeks
measure: Behavior
timeFrame: Baseline, 12 weeks
measure: Psychosocial variables
timeFrame: Baseline, 12 weeks
measure: Social Support
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Couple/Family Variables
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Deborah F Tate, PhD
role: STUDY_CHAIR
affiliation: University of NC-Chapel Hill
name: Candice Alick, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.