ObesityNCT05646771
Feasibility Study for Collaborate2Lose
A study testing Partner support in people with Obesity, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
In this feasibility study, dyads comprising a Veteran with obesity and a cohabiting adult support person will participate in group-based weight management counseling. Counseling will be delivered using an approved virtual technology platform. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Partner support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 8 Aug 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- BMI ≥ 30 kg/m2
- Had at least one visit with their primary care provider at the Madison VA within the past year (in-person or telehealth)
- Weight ≤ 420lbs due to limit of the study scales
- Cohabitating and daily contact for at least the past 6 months with an adult who can provide support (e.g. spouse/domestic partner, sibling, friend, family member) during the study period
- Desire to lose weight
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- Ability to speak English
- Agrees to attend visits per protocol
- Score of at least 4 out of 6 on a validated cognitive screener
- Access to hardware and internet connection to enable participation with approved virtual platform
- Individual email address
- Able to stand on a scale without assistance
- Aged 18 years or older
- Willing to participate
- Score of at least 4 out of 6 on a validated cognitive screener
- Ability to speak English
Who cannot join
- Medication other than metformin, incretin mimetics and incretin enhancers for type 2 diabetes due to increased risk for hypoglycemia
- Active dementia, psychiatric illness, or substance abuse
- History of bariatric surgery
- Diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, Torsemide 20 mg daily, Bumetanide 1 mg daily or any use of Metolazone). Use of potassium-sparing diuretics is acceptable.
- Chronic kidney disease at stage 4 or higher
- Participation in MOVE! in the past 3 months
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- Currently enrolled in a research or clinical program focusing on lifestyle change
- Pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
- Psychiatric illness not well-controlled by medication or therapy
- Score ≥ 8 on alcohol abuse screener
- Use of any drugs not prescribed, excluding cannabis
- Weight loss ≥ 10lb in the month prior to screening
- Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
- Is unable to control what food is prepared and/or served in household
- Problems with hearing that prevent attendance to a virtual class and talking on the telephone
- Currently enrolled in a research or clinical program focusing on lifestyle change
- History of bariatric surgery (reconfirm) or planning to have bariatric surgery in the next 18 months
- Current use of weight loss medications
- Worsening heart failure requiring medication dose change in the past 6 months
- Hospitalization for heart problems in the past 6 months
- Current treatment or treatment in the past 6 months for cancer (besides non-melanoma skin cancers)
- Dizziness or lightheadedness at rest or associated with physical activity
- Chest pain in the past 6 months
- Underweight (BMI < 18.5 kg/m2)
- Active dementia, uncontrolled psychiatric illness, or substance abuse
- Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
- Problems with hearing that prevent attendance to a virtual class and talking on the telephone
- Any severe health issue that would impair the partner's ability to provide support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study for Collaborate2Lose: Collaborating With Support Persons to Improve Long-term Weight Loss
In this feasibility study, dyads comprising a Veteran with obesity and a cohabiting adult support person will participate in group-based weight management counseling. Counseling will be delivered using an approved virtual technology platform. The curriculum is based on the VA national MOVE! weight management curriculum and involves additional content focusing on couples' communication skills.
- Conditions
- Obesity
- Being tested
- Partner support
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner supportBehavioural
Remotely delivered, partner-supported weight management counseling delivered in group visits every two weeks over 14 weeks (8 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Partner-Supported | Experimental | Dyads comprised of one Veteran and a cohabitating support person will participate in a behavioral weight management intervention. Receives: Behavioral: Partner support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening to enrollment ratio
We will calculate the screening to enrollment ratio. Our feasibility metric is 2:1 (i.e., 2 people start the phone screening in order to have one provide consent).
Measured: baseline
Retention Rate for primary outcome
The outcome assessment retention rate at 16 weeks will be calculated as [#of index participants who provide a weight at 16 weeks/number who provided a baseline weight]. Our metric is at least 80% retention at 16 weeks.
Measured: 16 weeks
Secondary outcomes (2)
Weight
Weight at 16 weeks is the primary endpoint. Veterans will be asked to weigh themselves during a virtual study visit, on a study-provided scale, while wearing light clothing (i.e., no outerwear such as jackets), with shoes removed.
Measured: 16 weeks
Intervention adherence
Intervention adherence is calculated as the average number of group sessions attended by index participants.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start13 Mar 2023
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
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 University of Wisconsin, MadisonThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- William S. Middleton Memorial Veterans Hospital
- Responsible party
- Sponsor
- Investigators
- Corrine Voils, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646771
- Sponsor's protocol ID
- 2021-0629
- Other IDs
- SMPH/SURGERY/WISOR, Protocol Version 1/24/23
- Status last verified
- Sep 2023
- First submitted
- 2 Dec 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Collaborate2Lose: Collaborating With Support Persons to Improve Long-term Weight Loss
- ClinicalTrials.gov ID
- NCT05646771
- Acronym / sponsor ID
- 2021-0629
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- William S. Middleton Memorial Veterans Hospital
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 12 Dec 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.
In this feasibility study, dyads comprising a Veteran with obesity and a cohabiting adult support person will participate in group-based weight management counseling. Counseling will be delivered using an approved virtual technology platform. The curriculum is based on the VA national MOVE! weight management curriculum and involves additional content focusing on couples' communication skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Partner-Supported | Experimental | Behavioral: Partner supportDyads comprised of one Veteran and a cohabitating support person will participate in a behavioral weight management intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged 18 years or older
- BMI ≥ 30 kg/m2
- Had at least one visit with their primary care provider at the Madison VA within the past year (in-person or telehealth)
- Weight ≤ 420lbs due to limit of the study scales
- Cohabitating and daily contact for at least the past 6 months with an adult who can provide support (e.g. spouse/domestic partner, sibling, friend, family member) during the study period
Key exclusion criteria (28 listed)
- Medication other than metformin, incretin mimetics and incretin enhancers for type 2 diabetes due to increased risk for hypoglycemia
- Active dementia, psychiatric illness, or substance abuse
- History of bariatric surgery
- Diuretic medication doses higher than hydrochlorothiazide 25 mg daily, furosemide 40 mg daily, Torsemide 20 mg daily, Bumetanide 1 mg daily or any use of Metolazone). Use of potassium-sparing diuretics is acceptable.
- Chronic kidney disease at stage 4 or higher
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 |
|---|---|---|
| Partner supportRemotely delivered, partner-supported weight management counseling delivered in group visits every two weeks over 14 weeks (8 sessions) | Behavioural | Partner-Supported |
Primary outcome
Screening to enrollment ratio
Time frame: baseline
We will calculate the screening to enrollment ratio. Our feasibility metric is 2:1 (i.e., 2 people start the phone screening in order to have one provide consent).
Retention Rate for primary outcome
Time frame: 16 weeks
The outcome assessment retention rate at 16 weeks will be calculated as [#of index participants who provide a weight at 16 weeks/number who provided a baseline weight]. Our metric is at least 80% retention at 16 weeks.
2 secondary outcomes
Weight
Time frame: 16 weeks
Intervention adherence
Time frame: 14 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 18 Sep 2023.
- Individual participant dataSharing planned: No
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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 Voils, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner support in people with Obesity, run by University of Wisconsin, Madison 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 16 inclusion and 28 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 18 Sep 2023. 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?
Screening to enrollment ratio (time frame: baseline). The study lists 2 primary outcomes in all. 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 18 Sep 2023.