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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02458053
Acronym
TEAM
Enrollment
104
Registered
2015-05-29
Start date
2016-02-29
Completion date
2017-08-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight, Weight Loss

Keywords

African American, male, couples, randomized control trial

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.

Interventions

BEHAVIORALAttends with partner

The index partner will participate in intervention as a couple with their female counterpart.

BEHAVIORALCouples Skill Training

Participants and their partners will attend a pre session covering topics to assist them in working together to facilitate lifestyle changes.

BEHAVIORALFace to face group sessions

Group sessions will consists of components in traditional weight management programs.

BEHAVIORALSelf Monitor

Participants will be instructed to monitor their eating and physical activity behaviors online/mobile application.

OTHERNotebook

The notebook will consist of behavioral lessons, diet and physical activity plans, and additional resources to assist participants in achieving their behavioral goals.

BEHAVIORALFeedback

Each participant will receive a tailored email providing feedback on their weekly progress.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
WeightBaseline, 6 weeks, 12 weeksBody weight(kg) expressed as a continuous variable will be collected on a digital scale.

Secondary

MeasureTime frameDescription
BMIBaseline,12 weeks
Blood pressureBaseline, 12 weeksBlood pressure will be assessed using DINAMAP monitor.
BehaviorBaseline, 12 weeksChanges in behavior will be assessed (e.g. diet (caloric Intake), and physical activity).
Waist CircumferenceBaseline,12 weeks
Social SupportBaseline, 6 weeks, 12 weeksSocial support of eating behaviors and physical activity will be assessed.
Couple/Family VariablesBaseline, 12 weeksCouple/ Family Variables will be assessed (e.g. marital satisfaction, transformation of motivation/communal coping, and family communication).
Psychosocial variablesBaseline, 12 weeksChanges in psychosocial variables will be assessed (Self-regulation of eating behaviors, self-efficacy of eating behaviors and physical activity).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026