Using Partners to Enhance Long-Term Weight Loss



Status:Recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 74
Updated:3/30/2019
Start Date:January 15, 2019
End Date:January 1, 2023
Contact:Kate Cronin, MPH
Email:cronin@surgery.wisc.edu
Phone:608-265-7835

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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.

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19-24, intervention will be withdrawn to examine sustainability of effects.

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

- Possess individual email address

- Possess individual smart phone with data and texting plan

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

- Blood pressure >= 160/100 mmHg

- Exertional chest pain or dyspnea

- 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)

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)
We found this trial at
1
site
Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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