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Completed

NCT Number: NCT02458053

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

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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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Attends with partner

Behavioral

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

Couples Skill Training

Behavioral

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

Behavioral

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

Self Monitor

Behavioral

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

Notebook

Other

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

Feedback

Behavioral

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

Primary outcomes

  1. Weight

    Time frame: Baseline, 6 weeks, 12 weeks

    Body weight(kg) expressed as a continuous variable will be collected on a digital scale.

Secondary outcomes

  1. Waist Circumference

    Time frame: Baseline,12 weeks

  2. BMI

    Time frame: Baseline,12 weeks

  3. Blood pressure

    Time frame: Baseline, 12 weeks

    Blood pressure will be assessed using DINAMAP monitor.

  4. Behavior

    Time frame: Baseline, 12 weeks

    Changes in behavior will be assessed (e.g. diet (caloric Intake), and physical activity).

  5. Psychosocial variables

    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).

  6. Social Support

    Time frame: Baseline, 6 weeks, 12 weeks

    Social support of eating behaviors and physical activity will be assessed.

  7. Couple/Family Variables

    Time frame: Baseline, 12 weeks

    Couple/ Family Variables will be assessed (e.g. marital satisfaction, transformation of motivation/communal coping, and family communication).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Acronym: TEAM

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 29, 2015
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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