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
- •Female caregivers with a biological child (either sex) aged 6-12 years
- •Caregiver is 3-12 months post undergoing a non-device based bariatric surgical procedure
- •Caregiver is able to read, write, and speak in English
- •Child has a BMI > the 70th and < 120% of the 95th percentile
- •Child not currently engaged in weight management (behavioral, pharmacologic)
- •Child has no chronic medical conditions or developmental disabilities
- •Child resides in her home > 75% of the time
- •Child is willing to participate
排除标准
- •Female caregiver is not pregnant at time of enrollment
- •Must not live >75 miles from Cincinnati Children's Hospital Main Campus.
- •Child BMI is > 120% of the 95th percentile
研究组 & 干预措施
Treatment
HALO is a mixed-delivery intervention (online learning, digital technologies, telehealth visits) co-designed with mothers that (a) uniquely tailors intervention content to integrate post-bariatric surgery guidelines to recommendations to reduce child obesity risk, (b) teaches mothers evidence-based parenting behaviors to support intergenerational lifestyle and home food environment changes, and (c) addresses unique barriers to family-level change identified by mothers post-bariatric surgery.
干预措施: HALO (Behavioral)
Enhanced Standard of Care
The comparator group will receive monthly mailings of publicly available and age-appropriate handouts on healthy eating, physical activity, screen time, and healthy sleep habits
干预措施: Enhanced Standard of Care (Behavioral)
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 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 26 weeks (post-treatment)(baseline to 26 weeks (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))