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OverweightTEAMNCT02458053

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

A study testing Attends with partner, Couples Skill Training and Face to face group sessions in people with Overweight and Weight Loss, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Overweight, Weight Loss, Obese
What is being tested?
Attends with partner, Couples Skill Training and Face to face group sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteUnited States
Study dates
Feb 2016to Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the 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.

Being tested
Attends with partner, Couples Skill Training, Face to face group sessions, Self Monitor, Notebook
Keywords
African American, male, couples, randomized control trial
Medical subject headings
Overweight, Weight Loss, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attends with partnerBehavioural

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

  • Couples Skill TrainingBehavioural

    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 sessionsBehavioural

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

  • Self MonitorBehavioural

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

  • NotebookOther

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

  • FeedbackBehavioural

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

Study groups in NCT02458053
Study groupRoleWhat they receive
TEAM EnhancedExperimentalThe enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.
Receives: Behavioral: Attends with partner; Behavioral: Couples Skill Training; Behavioral: Face to face group sessions; Behavioral: Self Monitor; Other: Notebook; Behavioral: Feedback
TEAM TraditionalActive comparatorThe intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.
Receives: Behavioral: Face to face group sessions; Behavioral: Self Monitor; Other: Notebook; Behavioral: Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

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

    Measured: Baseline, 6 weeks, 12 weeks

Secondary outcomes (7)

  1. Waist Circumference

    Measured: Baseline,12 weeks

  2. BMI

    Measured: Baseline,12 weeks

  3. Blood pressure

    Blood pressure will be assessed using DINAMAP monitor.

    Measured: Baseline, 12 weeks

  4. Behavior

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

    Measured: Baseline, 12 weeks

  5. Psychosocial variables

    Changes in psychosocial variables will be assessed (Self-regulation of eating behaviors, self-efficacy of eating behaviors and physical activity).

    Measured: Baseline, 12 weeks

  6. Social Support

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

    Measured: Baseline, 6 weeks, 12 weeks

  7. Couple/Family Variables

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

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2016
  4. Study completionAug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02458053
Sponsor's protocol ID
14-3193
Acronym
TEAM
Status last verified
Sep 2017
First submitted
27 May 2015
Last updated
14 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Alick CL, Samuel-Hodge C, Ward D, Ammerman A, Rini C, Tate DF. Together Eating & Activity Matters (TEAM): results of a pilot randomized-clinical trial of a spousal support weight loss intervention for Black men. Obes Sci Pract. 2018 Jan 17;4(1):62-75. doi: 10.1002/osp4.142. eCollection 2018 Feb.

    PubMed 29479466

Questions about this trial

What is this clinical trial studying?

A study testing Attends with partner, Couples Skill Training and Face to face group sessions in people with Overweight and Weight Loss, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02458053, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.

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