Status:
COMPLETED
Using Partners to Enhance Long-Term Weight Loss
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Duke University
RTI International
Conditions:
Obesity
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
Detailed Description
Couples will be randomized to a comprehensive weight program directed at patients alone or involving their partners. In months 1-6, all patients will receive group-based weight loss program. In months...
Eligibility Criteria
Inclusion
- Inclusion Criteria (patients):
- Aged 18-74 years
- BMI 27-29.9 kg/m2 plus at least one obesity-related comorbidity or BMI \>=30 kg/m2
- Cohabitating and at least daily contact with a spouse/domestic partner
- Access to reliable transportation
- Desire to lose weight
- Speak and read English
- Agree to attend visits per protocol
- Score of at least 4 out of 6 on Callahan cognitive screener
- Able to stand without assistance for weight measurements without assistance
- Possess individual email address
- Possess individual smart phone with data and texting plan
- Able to complete online screener without assistance
- Able to use a smartphone, tablet or computer with a video camera or webcam and microphone to download apps and to connect to a video conference call without assistance
- Exclusion Criteria (patients):
- Currently or planning to become pregnant or breastfeeding in the study timeframe
- Weight loss ≥ 5 lb in the month prior to screening
- Currently enrolled, or enrolled in previous 3 months, in a clinical or research program focusing on lifestyle change that could affect weight
- Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse
- Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening, chronic kidney disease stage 4 or higher)
- Living a nursing home or receiving visits from a home health care agency
- Planning to relocate in the next 2.5 years
- Current use of prescription or over-the-counter weight loss medications
- History of bariatric surgery or planning to have bariatric surgery in the study timeframe
- Impaired hearing
- Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer
- Use of insulin, sulfonylureas, or meglinitides for diabetes
- High diuretic dose
- Exertional chest pain, dizziness, or lightheadedness
- Pain or other condition than prohibits mild-moderate exercise
- History of ascites requiring paracentesis
- Inclusion criteria (partner):
- Aged 18 or older
- Willing to participate
- Access to reliable transportation
- Speak and read English
- Score of at least 4 out of 6 on Callahan cognitive screener
- Possess smart phone with data and texting plan (not shared with index patient)
- Possess email address (not shared with index patient)
- Able to complete online screener without assistance
- Exclusion criteria (partner):
- BMI \<18.5 kg/m2
- Significant dementia, schizophrenia, psychosis, or drug or alcohol abuse
- Residing in a nursing home or receiving home health care
- Impaired hearing
- Currently receiving, or received in the past 6 months, treatment for cancer other than skin cancer
- Chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization; unstable heart disease in the 6 months prior to screening)
Exclusion
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT03801174
Start Date
January 15 2019
End Date
March 20 2023
Last Update
June 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705