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Not Yet Recruiting NCT05646771

Feasibility Study for Collaborate2Lose

Conditions: Obesity

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 20
Sponsor: University of Wisconsin, Madison

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. The curriculum is based on the VA national MOVE! weight management curriculum and involves additional content focusing on couples' communication skills.

Eligibility Criteria

Inclusion Criteria (Veteran):Aged 18 years or olderBMI ≥ 30 kg/m2Had 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 scalesCohabitating 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 periodDesire to lose weightAbility to speak EnglishAgrees to attend visits per protocolScore of at least 4 out of 6 on a validated cognitive screenerAccess to hardware and internet connection to enable participation with approved virtual platformIndividual email addressAble to stand on a scale without assistanceExclusion Criteria (Veteran):Medication other than metformin, incretin mimetics and incretin enhancers for type 2 diabetes due to increased risk for hypoglycemiaActive dementia, psychiatric illness, or substance abuseHistory of bariatric surgeryDiuretic 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 higherParticipation in MOVE! in the past 3 monthsCurrently enrolled in a research or clinical program focusing on lifestyle changePregnancy or planning to become pregnant in the next 18 months, or breastfeedingPsychiatric illness not well-controlled by medication or therapyScore ≥ 8 on alcohol abuse screenerUse of any drugs not prescribed, excluding cannabisWeight loss ≥ 10lb in the month prior to screeningLiving in a facility such as a nursing home, skilled nursing facility, or assisted living facilityIs unable to control what food is prepared and/or served in householdProblems with hearing that prevent attendance to a virtual class and talking on the telephoneCurrently enrolled in a research or clinical program focusing on lifestyle changeHistory of bariatric surgery (reconfirm) or planning to have bariatric surgery in the next 18 monthsCurrent use of weight loss medicationsWorsening heart failure requiring medication dose change in the past 6 monthsHospitalization for heart problems in the past 6 monthsCurrent treatment or treatment in the past 6 months for cancer (besides non-melanoma skin cancers)Dizziness or lightheadedness at rest or associated with physical activityChest pain in the past 6 monthsInclusion Criteria (support person):Aged 18 years or olderWilling to participateScore of at least 4 out of 6 on a validated cognitive screenerAbility to speak EnglishExclusion Criteria (support person):Underweight (BMI < 18.5 kg/m2)Active dementia, uncontrolled psychiatric illness, or substance abuseLiving in a facility such as a nursing home, skilled nursing facility, or assisted living facilityProblems with hearing that prevent attendance to a virtual class and talking on the telephoneAny severe health issue that would impair the partner's ability to provide support

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05646771). StuddyBuddy aggregates publicly available trial information.