Using Partners to Enhance Long-Term Weight Loss

Study Overview
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Brief Summary
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This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.

Detailed Description
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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 7-18, all patients will receive a telephone-based weight loss maintenance intervention. In the partner-assisted arm only, partners will participate in the intervention, learning and practicing communication skills and support strategies. In months 19-24, intervention will be withdrawn to examine sustainability of effects. Due to COVID-19, option of doing screening and outcome assessment visits and attending the group classes (including exercise) remotely via a video conference may be available. COVID-19 survey will be administered every 3 month starting at screening/enrollment visit.

Official Title
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Using Partners to Enhance Long-Term Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Partner-assisted intervention
* Behavioral: Patient-only intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partner-assisted intervention<br>Patients and partners will receive intervention | Behavioral: Partner-assisted intervention<br>* All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.<br>|
| Active Comparator: Patient-only intervention<br>Patients will receive intervention | Behavioral: Patient-only intervention<br>* All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kg) | Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caloric intake (kcal) | average estimated daily intake from ASA24 Dietary Assessment Tool, assessed every 6 months with 24 months as primary endpoint | 24 months | 
| Physical activity | average daily minutes of moderate activity over past 7 days from Fitbit, assessed every 6 months with 24 months as primary endpoint | 24 months |