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Completed

NCT Number: NCT05646771

Feasibility Study for Collaborate2Lose

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partner support

Behavioral

Remotely delivered, partner-supported weight management counseling delivered in group visits every two weeks over 14 weeks (8 sessions)

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Weight

    Time frame: 16 weeks

    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.

  2. Intervention adherence

    Time frame: 14 weeks

    Intervention adherence is calculated as the average number of group sessions attended by index participants.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • William S. Middleton Memorial Veterans Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2022
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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