NCT02458053

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

May 27, 2015

Last Update Submit

September 13, 2017

Conditions

OverweightWeight LossObese

Keywords

African Americanmalecouplesrandomized control trial

Outcome Measures

Primary Outcomes (1)

  • Weight

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

    Baseline, 6 weeks, 12 weeks

Secondary Outcomes (7)

  • Waist Circumference

    Baseline,12 weeks

  • BMI

    Baseline,12 weeks

  • Blood pressure

    Baseline, 12 weeks

  • Behavior

    Baseline, 12 weeks

  • Psychosocial variables

    Baseline, 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

TEAM Enhanced

EXPERIMENTAL

The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.

Behavioral: Attends with partnerBehavioral: Couples Skill TrainingBehavioral: Face to face group sessionsBehavioral: Self MonitorOther: NotebookBehavioral: Feedback

TEAM Traditional

ACTIVE COMPARATOR

The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.

Behavioral: Face to face group sessionsBehavioral: Self MonitorOther: NotebookBehavioral: Feedback

Interventions

Attends with partnerBEHAVIORAL

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

TEAM Enhanced
Couples Skill TrainingBEHAVIORAL

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

TEAM Enhanced
Face to face group sessionsBEHAVIORAL

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

TEAM EnhancedTEAM Traditional
Self MonitorBEHAVIORAL

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

TEAM EnhancedTEAM Traditional
NotebookOTHER

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

TEAM EnhancedTEAM Traditional
FeedbackBEHAVIORAL

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

TEAM EnhancedTEAM Traditional

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 29479466DERIVED

MeSH Terms

Conditions

OverweightWeight LossObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Deborah F Tate, PhD

    University of North Carolina, Chapel Hill

    STUDY CHAIR

  • Candice Alick, MS

    University of NC-Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2015

First Posted

May 29, 2015

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)