University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT02458053
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.
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Notify Me18 year–65 year
Male
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The index partner will participate in intervention as a couple with their female counterpart.
Participants and their partners will attend a pre session covering topics to assist them in working together to facilitate lifestyle changes.
Group sessions will consists of components in traditional weight management programs.
Participants will be instructed to monitor their eating and physical activity behaviors online/mobile application.
The notebook will consist of behavioral lessons, diet and physical activity plans, and additional resources to assist participants in achieving their behavioral goals.
Each participant will receive a tailored email providing feedback on their weekly progress.
Time frame: Baseline, 6 weeks, 12 weeks
Body weight(kg) expressed as a continuous variable will be collected on a digital scale.
Time frame: Baseline,12 weeks
Time frame: Baseline,12 weeks
Time frame: Baseline, 12 weeks
Blood pressure will be assessed using DINAMAP monitor.
Time frame: Baseline, 12 weeks
Changes in behavior will be assessed (e.g. diet (caloric Intake), and physical activity).
Time frame: Baseline, 12 weeks
Changes in psychosocial variables will be assessed (Self-regulation of eating behaviors, self-efficacy of eating behaviors and physical activity).
Time frame: Baseline, 6 weeks, 12 weeks
Social support of eating behaviors and physical activity will be assessed.
Time frame: Baseline, 12 weeks
Couple/ Family Variables will be assessed (e.g. marital satisfaction, transformation of motivation/communal coping, and family communication).
University of North Carolina, Chapel Hill
Other
Acronym: TEAM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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