Changing Health and Lifestyle Behaviors of Offspring Following Maternal Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment)
研究概览
简要总结
This is the Phase 2 pilot/feasibility randomized controlled trial of HALO (Health And Lifestyle Behaviors In Offspring), a parent-led behavioral intervention targeting a high-risk pediatric population (i.e., residing offspring ages 6-12; body mass index > the 70th and < 120% of the 95th percentiles of mothers with severe obesity) that is uniquely well-timed, when mothers are highly engaged in behavior change and losing weight during the first year following bariatric surgery.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 26 weeks (post-treatment)
时间窗: baseline to 26 weeks (post-treatment)
Trained assessors will measure child height/weight using a standardized protocol. These measurements will be converted to body mass index (kg/m\^2) and then standardized by child age and sex
Preliminary Efficacy - Change in child body mass index standardized for age/sex from baseline to 52 weeks (6-month follow-up)
时间窗: baseline to 52 weeks (6-month follow-up post-treatment)
Trained assessors will measure child height/weight using a standardized protocol. These measurements will be converted to body mass index (kg/m\^2) and then standardized by child age and sex
次要结局
- Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 26 weeks (post-treatment)(baseline to 26 weeks (post-treatment))
- Secondary - Change in child daily intake of total kcals, and kcals from red foods, sugar-sweetened beverages, and fruits and vegetables from baseline to 26 weeks (post-treatment) using a 3-day dietary recall(baseline to 26 weeks (post-treatment))
- Secondary - Change in child daily intake of total kcals, and kcals from red foods, sugar-sweetened beverages, and fruits and vegetables from baseline to 52 weeks (6-month follow-up) using a 3-day dietary recall(baseline to 52 weeks (6-month follow-up post-treatment))
- Secondary - Change in child minutes of moderate to vigorous physical activity (MVPA) from baseline to 52 weeks (6-month follow-up)(baseline to 52 weeks (6-month follow-up post-treatment))
- Secondary - Change in mother-reported child feeding practices of restriction, pressure to eat, perceived responsibility, and monitoring from baseline to 26 weeks (post-treatment)(baseline to 26 weeks (post-treatment))
- Secondary - Change in mother use of encouragement/modeling from baseline to 26 weeks (post-treatment)(baseline to 26 weeks (post-treatment))
- Secondary - Change in mother-reported child feeding practices of restriction, pressure to eat, perceived responsibility, and monitoring from baseline to 52 weeks (6-month follow-up)(baseline to 52 weeks (6-month follow-up post-treatment))
- Secondary - Change in child hours of screen time from baseline to 52 weeks (6-month follow-up)(baseline to 52 weeks (6-month follow-up post-treatment))
- Secondary - Change in physical home food environment total kcals, and kcals from sugar-sweetened beverages, snack foods, fruits, and vegetables from baseline to 26 weeks (post-treatment)(baseline to 26 weeks (post-treatment))
- Secondary - Change in child hours of screen time from baseline to 26 weeks (post-treatment)(baseline to 26 weeks (post-treatment))
- Secondary - Change in mother use of encouragement/modeling from baseline to 52 weeks (6-month follow-up)(baseline to 52 weeks (6-month follow-up post-treatment))
- Secondary - Change in physical home food environment total kcals, and kcals from sugar-sweetened beverages, snack foods, fruits, and vegetables from baseline to 52 weeks (6-month follow-up)(baseline to 52 weeks (6-month follow-up post-treatment))