ClinicalTrials.gg
CompletedNCT05448313Updated Nov 21, 2025

Collaborate2Lose: Involving Support Persons in Weight Management

An interventional study of Dyadic intervention and Veteran-only intervention in Obesity, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Obesity

Keywords

  • weight loss
  • body weight changes
  • body weight
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 300 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient inclusion criteria

  • aged 18 years or older
  • >= 30 kg/m2
  • at least one visit with a VA primary care provider within the past year
  • weight \<=420 lb due to study scale limits
  • 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
  • aged 18 years or older
  • willing to participate
  • \< 2 errors on a validated 6-item cognitive screener
  • ability to speak English
  • individual email address

Exclusion criteria

Exclusion Criteria:

Patient exclusion criteria

  • active dementia or substance abuse
  • history of bariatric surgery or planning to have bariatric surgery in the next 18 months
  • pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
  • weight loss >= 10 lb in the month prior to screening
  • living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
  • 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)
  • participation in VA MOVE! weight management program in the past 6 months
  • current participation in a research or clinical program focusing on lifestyle change
  • vomits once or more per week Partner exclusion criteria
  • \< 18.5 kg/m2
  • active dementia or substance abuse
  • impaired hearing
  • chronic or unstable illness that would impair their ability to provide support
  • living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Dyadic intervention

    Veterans and their support person will participate in MOVE!

    Behavioral: Dyadic intervention

  • Active comparator
    Veteran-only intervention

    Veterans will participate in MOVE! alone

    Behavioral: Veteran-only intervention

Interventions

  • BehavioralDyadic 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.

  • BehavioralVeteran-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.

06

What researchers measure

Primary outcomes

  1. Body weight (lb)

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

    Time frame: 72 weeks

Secondary outcomes

  1. obesity-specific quality of life

    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

    Time frame: 72 weeks

07

Study locations

1 site
  • William S. Middleton Memorial Veterans Hospital, Madison, WI
    Madison, Wisconsin 53705-2254, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Nov 2025, 27 months.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 27 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2022
First posted
Jul 7, 2022
StartActual
Aug 1, 2023
Primary completionActual
Nov 11, 2025
CompletionActual
Nov 11, 2025
Last update
Nov 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05448313
Responsible party
Sponsor
First posted
Jul 7, 2022
Start date
Aug 1, 2023
Primary completion
Nov 11, 2025
Completion
Nov 11, 2025
Last update
Nov 21, 2025

Study contacts

Corrine I. Voils, PhD
principal investigator · William S. Middleton Memorial Veterans Hospital, Madison, WI

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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