Clinical Trials Directory

Trials / Completed

CompletedNCT02458053

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
104 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
Male
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAttends with partnerThe index partner will participate in intervention as a couple with their female counterpart.
BEHAVIORALCouples Skill TrainingParticipants and their partners will attend a pre session covering topics to assist them in working together to facilitate lifestyle changes.
BEHAVIORALFace to face group sessionsGroup sessions will consists of components in traditional weight management programs.
BEHAVIORALSelf MonitorParticipants will be instructed to monitor their eating and physical activity behaviors online/mobile application.
OTHERNotebookThe notebook will consist of behavioral lessons, diet and physical activity plans, and additional resources to assist participants in achieving their behavioral goals.
BEHAVIORALFeedbackEach participant will receive a tailored email providing feedback on their weekly progress.

Timeline

Start date
2016-02-01
Primary completion
2016-12-01
Completion
2017-08-01
First posted
2015-05-29
Last updated
2017-09-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02458053. Inclusion in this directory is not an endorsement.