N/A
N=231
Using Partners to Enhance Long-Term Weight Loss
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03801174 ↗Enrolled (actual)
231
Serious AEs
2.6%
Results posted
Jun 2024
Primary outcome: Primary: Body Weight (kg) — 104.46; 104.23 kilograms — p=.804
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Partner-assisted intervention (Behavioral); Patient-only intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight (kg) |
104.46; 104.23 | .804 |
| SECONDARY Caloric Intake (kcal) |
1835; 1885 | .590 |
| SECONDARY Physical Activity |
7400; 8206 | .069 |
Summary
This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03801174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.