Using Partners to Enhance Long-Term Weight Loss (Partner2Lose)

University of Wisconsin (UW)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Partner-assisted intervention; Behavioral: Patient-only intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03801174

1R01DK111491-01A1 (U.S. NIH Grant/Contract)

A539722 (Other Identifier)

2018-1400-CP028 (Other Identifier)

SMPH/SURGERY (Other Identifier)

2018-1400

Details and patient eligibility

About

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

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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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

Enrollment: 346 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

346 participants in 2 patient groups

Partner-assisted intervention

Experimental group

Description:

Patients and partners will receive intervention

Treatment:

Behavioral: Partner-assisted intervention

Patient-only intervention

Active Comparator group

Description:

Patients will receive intervention

Treatment:

Behavioral: Patient-only intervention