Using Partners to Enhance Long-Term Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 1
- 主要终点
- Body Weight (kg)
研究概览
简要总结
This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program.
详细描述
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 In months 19-24, intervention will be withdrawn to examine sustainability of effects.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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
排除标准
- •(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)
研究组 & 干预措施
Partner-assisted intervention
Patients and partners will receive intervention
干预措施: Partner-assisted intervention (Behavioral)
Patient-only intervention
Patients will receive intervention
干预措施: Patient-only intervention (Behavioral)
结局指标
主要结局
Body Weight (kg)
时间窗: 24 months
Measured on a calibrated, digital scale to the nearest 0.1 kg, assessed every 6 months with 24 months as primary endpoint
次要结局
- Caloric Intake (kcal)(24 months)
- Physical Activity(24 months)