Feasibility Study for Collaborate2Lose

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Partner support

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kara L Gavin, PhD; Phone Number: 6082620950; Email: gavin@surgery.wisc.edu
• Study Contact Backup: Name: Jennie Embree; Email: jlembree@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (Veteran):

1. Aged 18 years or older
2. BMI ≥ 30 kg/m2
3. Had at least one visit with their primary care provider at the Madison VA within the past year (in-person or telehealth)
4. Weight ≤ 420lbs due to limit of the study scales
5. 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
6. Desire to lose weight
7. Ability to speak English
8. Agrees to attend visits per protocol
9. Score of at least 4 out of 6 on a validated cognitive screener
10. Access to hardware and internet connection to enable participation with approved virtual platform
11. Individual email address
12. Able to stand on a scale without assistance

Exclusion Criteria (Veteran):

1. Medication other than metformin, incretin mimetics and incretin enhancers for type 2 diabetes due to increased risk for hypoglycemia
2. Active dementia, psychiatric illness, or substance abuse
3. History of bariatric surgery
4. 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.
5. Chronic kidney disease at stage 4 or higher
6. Participation in MOVE! in the past 3 months
7. Currently enrolled in a research or clinical program focusing on lifestyle change
8. Pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
9. Psychiatric illness not well-controlled by medication or therapy
10. Score ≥ 8 on alcohol abuse screener
11. Use of any drugs not prescribed, excluding cannabis
12. Weight loss ≥ 10lb in the month prior to screening
13. Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
14. Is unable to control what food is prepared and/or served in household
15. Problems with hearing that prevent attendance to a virtual class and talking on the telephone
16. Currently enrolled in a research or clinical program focusing on lifestyle change
17. History of bariatric surgery (reconfirm) or planning to have bariatric surgery in the next 18 months
18. Current use of weight loss medications
19. Worsening heart failure requiring medication dose change in the past 6 months
20. Hospitalization for heart problems in the past 6 months
21. Current treatment or treatment in the past 6 months for cancer (besides non-melanoma skin cancers)
22. Dizziness or lightheadedness at rest or associated with physical activity
23. Chest pain in the past 6 months

Inclusion Criteria (support person):

1. Aged 18 years or older
2. Willing to participate
3. Score of at least 4 out of 6 on a validated cognitive screener
4. Ability to speak English

Exclusion Criteria (support person):

1. Underweight (BMI < 18.5 kg/m2)
2. Active dementia, uncontrolled psychiatric illness, or substance abuse
3. Living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
4. Problems with hearing that prevent attendance to a virtual class and talking on the telephone
5. Any severe health issue that would impair the partner's ability to provide support

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: William S. Middleton Memorial Veterans Hospital
• Investigators: Principal Investigator: Corrine Voils, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-0629; SMPH/SURGERY/WISOR (Other Identifier: UW Madison); Protocol Version 1/24/23 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No