ObesityNCT05448313
Collaborate2Lose: Involving Support Persons in Weight Management
A study testing Dyadic intervention and Veteran-only intervention in people with Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Dyadic intervention and Veteran-only intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 11 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- BMI < 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
Trial locations and contacts
1 site in 1 country.
United States1 site
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
About this study
Official title: Collaborate2Lose: Collaborating With Romantic and Non-romantic Support Persons to Improve Long-term Weight Loss
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.
- Conditions
- Obesity
- Being tested
- Dyadic intervention, Veteran-only intervention
- Keywords
- weight loss, body weight changes, body weight
- Medical subject headings
- Obesity, Weight Loss, Body Weight Changes, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic interventionBehavioural
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.
Veteran-only interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic intervention | Experimental | Veterans and their support person will participate in MOVE! Receives: Behavioral: Dyadic intervention |
| Veteran-only intervention | Active comparator | Veterans will participate in MOVE! alone Receives: Behavioral: Veteran-only intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Aug 2023
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Corrine I. Voils, PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448313
- Sponsor's protocol ID
- IIR 21-101
- Status last verified
- Nov 2025
- First submitted
- 1 Jul 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborate2Lose: Collaborating With Romantic and Non-romantic Support Persons to Improve Long-term Weight Loss
- ClinicalTrials.gov ID
- NCT05448313
- Acronym / sponsor ID
- IIR 21-101
- Conditions
- Obesity
- Keywords
- weight loss, body weight changes, body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic intervention | Experimental | Behavioral: Dyadic interventionVeterans and their support person will participate in MOVE! |
| Veteran-only intervention | Active comparator | Behavioral: Veteran-only interventionVeterans will participate in MOVE! alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
- weight <=420 lb due to study scale limits
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic interventionDyads 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. | Behavioural | Dyadic intervention |
| Veteran-only interventionVeterans 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. | Behavioural | Veteran-only intervention |
Primary outcome
Body weight (lb)
Time frame: 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
1 secondary outcome
obesity-specific quality of life
Time frame: 72 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrine I. Voils, PhD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic intervention and Veteran-only intervention in people with Obesity, run by VA Office of Research and Development 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 18 inclusion and 18 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 21 Nov 2025. 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?
Body weight (lb) (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2025.