Using Partners to Enhance Long-Term Weight Loss

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2023-03-20

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.

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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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Partner-assisted intervention

Patients and partners will receive intervention

Group Type EXPERIMENTAL

Partner-assisted intervention

Intervention Type BEHAVIORAL

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.

Patient-only intervention

Patients will receive intervention

Group Type ACTIVE_COMPARATOR

Patient-only intervention

Intervention Type BEHAVIORAL

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.

Interventions

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Partner-assisted intervention

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.

Intervention Type BEHAVIORAL

Patient-only intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes