Obesity
Conditions
Brief 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.
Interventions
BEHAVIORALPartner support
Remotely delivered, partner-supported weight management counseling delivered in group visits every two weeks over 14 weeks (8 sessions)
Sponsors
William S. Middleton Memorial Veterans Hospital
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will receive the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening to enrollment ratio | 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). |
| Retention Rate for primary outcome | 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
| Measure | Time frame | Description |
|---|---|---|
| Weight | 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. |
| Intervention adherence | 14 weeks | Intervention adherence is calculated as the average number of group sessions attended by index participants. |
Countries
United States
Outcome results
None listed