Clincosm LogoSign in Get a demo

Collaborate2Lose: Involving Support Persons in Weight Management

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05448313
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
28
Anticipated Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dyadic intervention
  • Behavioral: Veteran-only intervention
 N/A

Detailed Description

Dyads comprising a Veteran with obesity and a cohabitating adult will be randomized to participate in a weight management program by the Veteran alone or with their support person. The program will be delivered by research staff using a secure video platform. Outcomes will be assessed remotely at baseline and weeks 24, 48, and 72, with 72 weeks as the primary endpoint.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Collaborate2Lose: Collaborating With Romantic and Non-romantic Support Persons to Improve Long-term Weight Loss
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dyadic intervention

Veterans and their support person will participate in MOVE!

Behavioral: Dyadic intervention
Dyads comprising a Veteran and cohabitating support person will participate in the 16-week VA MOVE! weight loss program delivered by video platform. They will then participate in 6 group sessions focused on weight maintenance skills. Communication skills will be taught throughout the intervention.
Active Comparator: Veteran-only intervention

Veterans will participate in MOVE! alone

Behavioral: Veteran-only intervention
Veterans will participate in a 72-week weight management program delivered by video platform. 16 sessions will address weight loss, with 6 additional ones addressing weight loss maintenance.

Outcome Measures

Primary Outcome Measures

  1. Body weight (lb) [72 weeks]

    Measured on a calibrated, digital scale to the nearest 0.1 lb, assessed every 24 weeks with 72 weeks as the primary endpoint

Secondary Outcome Measures

  1. obesity-specific quality of life [72 weeks]

    Measured on the 31-item, reliable, valid Impact of Weight on Quality of Life-Lite scale. Items are rated on a 5-point graded response scale ranging from never true to always true. Possible scores range from 31 to 155, with greater scores corresponding to greater impairment in quality of life. The measure will be administered every 24 weeks with 72 weeks as the primary endpoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patient inclusion criteria

  • aged 18 years or older

  • BMI 30 kg/m2

  • at least one visit with a VA primary care provider within the past year

  • have been cohabitating and have daily contact over the past 6 months with an adult who can provide support (e.g., spouse/domestic partner, sibling, adult child, friend, family member) for the next 18 months

  • desire to lose weight

  • able to stand for weight measurements without assistance

  • < 2 errors on a validated 6-item cognitive screener

  • ability to speak English

  • agrees to attend visits per protocol

  • individual email-address

  • access to hardware and internet connection to enable participation with approved virtual platform Partner inclusion criteria

  • willing to participate

  • < 2 errors on a validated 6-item cognitive screener

  • ability to speak English

Exclusion Criteria:

Patient exclusion criteria

  • active dementia or substance abuse

  • history of bariatric surgery

  • current participation in a research or clinical program focusing on lifestyle change

  • pregnancy, breastfeeding, or planning to become pregnant in the next 18 months

  • weight loss 10 lb in the month prior to screening

  • residing in a nursing home or receiving long-term home health care

  • unable to control what food is purchased and / or served

  • impaired hearing

  • current use of weight loss medications

  • chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization)

Partner exclusion criteria

  • active dementia or substance abuse

  • residing in a nursing home or receiving home health care

  • impaired hearing

  • chronic or unstable illness that would impair their ability to provide support

Contacts and Locations

Locations

Site City State Country Postal Code
1 William S. Middleton Memorial Veterans Hospital, Madison, WI Madison Wisconsin United States 53705

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Corrine I. Voils, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT05448313
Other Study ID Numbers:
  • IIR 21-101
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
weight loss
body weight changes
body weight

Study Results

No Results Posted as of Jul 14, 2022