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

Overweight Clinical Trial

— TEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458053
• Other study ID #: 14-3193
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: September 13, 2017
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obese
• Overweight
• Weight Loss

Intervention

Behavioral:
• Attends with partner
The index partner will participate in intervention as a couple with their female counterpart.
• Couples Skill Training
Participants and their partners will attend a pre session covering topics to assist them in working together to facilitate lifestyle changes.
• Face to face group sessions
Group sessions will consists of components in traditional weight management programs.
• Self Monitor
Participants will be instructed to monitor their eating and physical activity behaviors online/mobile application.

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

Behavioral:
• Feedback
Each participant will receive a tailored email providing feedback on their weekly progress.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Body weight(kg) expressed as a continuous variable will be collected on a digital scale.	Baseline, 6 weeks, 12 weeks
Secondary	Waist Circumference		Baseline,12 weeks
Secondary	BMI		Baseline,12 weeks
Secondary	Blood pressure	Blood pressure will be assessed using DINAMAP monitor.	Baseline, 12 weeks
Secondary	Behavior	Changes in behavior will be assessed (e.g. diet (caloric Intake), and physical activity).	Baseline, 12 weeks
Secondary	Psychosocial variables	Changes in psychosocial variables will be assessed (Self-regulation of eating behaviors, self-efficacy of eating behaviors and physical activity).	Baseline, 12 weeks
Secondary	Social Support	Social support of eating behaviors and physical activity will be assessed.	Baseline, 6 weeks, 12 weeks
Secondary	Couple/Family Variables	Couple/ Family Variables will be assessed (e.g. marital satisfaction, transformation of motivation/communal coping, and family communication).	Baseline, 12 weeks