Partners in Health: A Couples-based Approach to Obesity Prevention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gestational weight gain
研究概览
简要总结
The purpose of this pilot study is to test the feasibility of an innovative, couples based approach to weight management during pregnancy. The primary hypothesis is that a couples-based behavioral weight management program will reduce the rate of gestational weight gain compared to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- 是
入选标准
- •Pregnant Women
- •>18 years old
- •15-22 weeks gestation
- •BMI >= 25
- •cohabitating with partner for at least 3 months or recently married
- •willing to consent
- •Non-pregnant Partner
- •BMI >= 25
- •cohabitating with partner for at least 3 months or recently married
- •willing to consent
排除标准
- •Untreated medical or psychological problem
- •Inability to be physically active
结局指标
主要结局
Gestational weight gain
时间窗: 16 weeks gestation, 35 weeks gestation
Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.
次要结局
- Partner's weight loss(study entry, when pregnant partner reaches 35 weeks gestation)
研究者
Suzanne Phelan
Associate Professor
California Polytechnic State University-San Luis Obispo