Feasibility Study for Collaborate2Lose

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study for Collaborate2Lose: Collaborating With Support Persons to Improve Long-term Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Partner support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Veteran): 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 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 Exclusion Criteria (Veteran): 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 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 Inclusion Criteria (support person): 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 Exclusion Criteria (support person): 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partner-Supported<br>Dyads comprised of one Veteran and a cohabitating support person will participate in a behavioral weight management intervention. | Behavioral: Partner support<br>* Remotely delivered, partner-supported weight management counseling delivered in group visits every two weeks over 14 weeks (8 sessions)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 16 weeks | 
| Intervention adherence | Intervention adherence is calculated as the average number of group sessions attended by index participants. | 14 weeks |