Exploring the Familial Reach of Adolescent Obesity Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Family-level changes to the shared home environment.
研究概览
简要总结
An observational study ancillary to the randomized clinical trial (RCT) TEENS+ (R01HD095910), a family-based lifestyle intervention, for adolescents with obesity, to determine: 1) if family-wide changes to the shared home environment are implemented, 2) if ripple effects to untreated family members are observed, and 3) whether these changes are predictive of adolescents' weight management success.
Funding support from NIH via R21HD105906.
详细描述
Investigators will recruit non-targeted children (8-17yrs) and caregivers living in the same household as the target TEENS+ parent/adolescent dyad. At 0, 2, 4 and 8m, the target adolescent/parent dyad (n=60), and non-targeted children and caregivers will complete anthropometric assessments, and measures of the shared home feeding and weight-related environment will be conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated children: must be between 8-17 years of age and primarily living in the same household as the TEENS+ participants.
- •Untreated caregiver: must be 18 years of age or older and primarily living in the same household as the TEENS+ participants.
- •Treated caregivers: must have another individual in the household that meets the eligbility for an untreated child or untreated caregiver.
排除标准
- •temporarily (<1yr) living in the home
- •children with a BMI<5th%ile or caregivers with a BMI<18.5 kg/m2
- •non-English speaking
- •medical condition(s) that may be associated with unintentional weight change or significant disruption to eating behaviors (e.g., hypothalamic injury, Prader-Willi, G-tube placement, or malignancy
- •clinically significant eating disorder (e.g., anorexia nervosa or bulimia nervosa)
- •following a medically-supervised/prescribed diet
- •psychiatric, cognitive, physical or developmental conditions that would impair the individual's ability to complete assessments.
结局指标
主要结局
Family-level changes to the shared home environment.
时间窗: 4 months (baseline to 4 months)
Changes in the home food available and the home exercise and electronic media environment.
Weight changes.
时间窗: 4 months (baseline to 4 months)
Weight changes observed among untreated individuals (child zBMI and caregiver % weight loss)
Household changes and target adolescent weight.
时间窗: 8 months [weight loss (baseline to 4 months) and maintenance (4-8)]
Associations between household changes and target adolescent weight loss and maintenance.
次要结局
未报告次要终点