Feasibility Study for Collaborate2Lose

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05646771
• Other study ID #: 2021-0629
• Secondary ID: SMPH/SURGERY/WIS
• Status: Completed
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: August 8, 2023

Study information

• Verified date: September 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	William S. Middleton Memorial Veterans Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Intervention adherence	Intervention adherence is calculated as the average number of group sessions attended by index participants.	14 weeks