Changing Habits Together at Home Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Feasibility Data
研究概览
简要总结
This study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). A factorial design (2 X 2 X 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.
详细描述
All participants in this study will receive 10 core coaching sessions. These sessions will be conducted between study staff and parents of children ages 8 - 12 who are in the 85th percentile or higher on the BMI scale. The sessions will focus on healthy habits and positive reinforcement for behavior changes within the house that could lead to a reduction in the the child's BMI. In addition to the 10 core sessions, some participants will have difference components of the intervention added to their treatment: conducting the first session in-person, having a second caregiver participate in some of the coaching calls, and/or having the child use a wifi-enabled scale for weekly weigh-ins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Parent/primary caregiver of child in the 8-12 year old age range based on child birth date
- •The child's BMI is greater than or equal to the 85th percentile according to CDC age and sex reference standards
- •Child lives with parent/primary caregiver 50% of the time
- •Willing to have a second caregiver participate in this study
- •Wifi at home
- •The parent and child can speak, read, and understand English
排除标准
- •Kidney disease, Type 1 diabetes, Lupus, current Cancer diagnosis,
- •Chromosomal abnormality such as Down's syndrome or Turner's syndrome
- •Child taken any steroid medications such as Prednisone, Prenisilone and Decadron on a daily basis for more than 1 month in the past 6 months (this does not include inhalers with steroids)
- •Child enrolled in a different weight management program
- •Family participating in any other child research study related to dietary intake, physical activity, weight
- •Plans to move more than 50 miles from your present location within the next 6 months
结局指标
主要结局
Feasibility Data
时间窗: 4 months
Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.
次要结局
- Child BMI(4 months)