NCT05448313已完成不适用
Collaborate2Lose: Collaborating With Romantic and Non-romantic Support Persons to Improve Long-term Weight Loss
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Body weight (lb)
研究概览
简要总结
This study involves an evaluation of whether social support from a cohabitating adult improves Veteran weight loss in a weight management program.
详细描述
Dyads comprising a Veteran with obesity and a cohabitating adult will be randomized to participate in a weight management program by the Veteran alone or with their support person. The program will be delivered by research staff using a secure video platform. Outcomes will be assessed remotely at baseline and weeks 24, 48, and 72, with 72 weeks as the primary endpoint.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient inclusion criteria
- •aged 18 years or older
- •BMI >= 30 kg/m2
- •at least one visit with a VA primary care provider within the past year
- •weight <=420 lb due to study scale limits
- •have been cohabitating and have daily contact over the past 6 months with an adult who can provide support (e.g., spouse/domestic partner, sibling, adult child, friend, family member) for the next 18 months
- •desire to lose weight
- •able to stand for weight measurements without assistance
- •< 2 errors on a validated 6-item cognitive screener
- •ability to speak English
- •agrees to attend visits per protocol
- •individual email-address
- •access to hardware and internet connection to enable participation with approved virtual platform Partner inclusion criteria
- •aged 18 years or older
- •willing to participate
- •< 2 errors on a validated 6-item cognitive screener
- •ability to speak English
- •individual email address
排除标准
- •Patient exclusion criteria
- •active dementia or substance abuse
- •history of bariatric surgery or planning to have bariatric surgery in the next 18 months
- •pregnancy or planning to become pregnant in the next 18 months, or breastfeeding
- •weight loss >= 10 lb in the month prior to screening
- •living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
- •unable to control what food is purchased and / or served
- •impaired hearing
- •current use of weight loss medications
- •chronic or unstable illness that would limit ability to participate (e.g., recent hospitalization)
- •participation in VA MOVE! weight management program in the past 6 months
- •current participation in a research or clinical program focusing on lifestyle change
- •vomits once or more per week Partner exclusion criteria
- •BMI < 18.5 kg/m2
- •active dementia or substance abuse
- •impaired hearing
- •chronic or unstable illness that would impair their ability to provide support
- •living in a facility such as a nursing home, skilled nursing facility, or assisted living facility
结局指标
主要结局
Body weight (lb)
时间窗: 72 weeks
Measured on a calibrated, digital scale to the nearest 0.1 lb, assessed every 24 weeks with 72 weeks as the primary endpoint
次要结局
- obesity-specific quality of life(72 weeks)
研究者
研究点 (2)
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