Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Feasibility - Interviews
研究概览
简要总结
The main purpose of vHAPPY is to pilot test a new type of virtual family-based healthy lifestyle program for children aged 8-14 with obesity and their caregivers. vHAPPY aims to (1) Transition a previously developed acceptance-based behavioral treatment to web-based platform, utilizing qualitative and quantitative program evaluation data from past participants. (2) Determine the feasibility, acceptability, and preliminary outcomes of the adapted web-based treatment. (3) Evaluate whether the adapted web-based treatment (self-guided treatment + brief coaching) is similar to the traditional treatment (interventionist-guided treatment) in terms of feasibility, acceptability, and preliminary outcomes utilizing a non-randomized sequential arm design.
详细描述
Caregiver and child pairs will complete a 14 week virtual, self-guided healthy lifestyle program including education on health and wellness topics such as food groups, physical activity and stress management. Special skill builders for managing the thoughts, feelings and emotions associated with changing health behaviors will also be included. Pairs will have biweekly 15 minute coaching sessions to check in on progress in the past week, set goals and problem solve. Optional group sessions will be offered for peer support. In order to assess progress, pairs will also complete assessment visits before and after the program. These visits include one virtual assessment via Zoom and one in-person assessment at the University of Alabama at Birmingham. Caregivers and children will complete questionnaires and measures such has height, weight, blood pressure and a finger prick.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who:
- •have a BMI ≥ 85th percentile;
- •are 8 and 14 years old at the beginning of treatment;
- •can read, write, and speak English, along with their caregiver;
- •plan to stay living in the local area during the study period;
- •have a consenting caregiver who can commit to all study procedures.
排除标准
- •Children who:
- •have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function;
- •are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.
结局指标
主要结局
Feasibility - Interviews
时间窗: 3.5 months
Semi-structured group interviews will assess caregiver and child experiences with the program.
Feasibility - Surveys
时间窗: 3.5 months
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Acceptability - Interviews
时间窗: 3.5 months
Semi-structured group interviews will assess caregiver and child experiences with the program.
Acceptability - Surveys
时间窗: 3.5 months
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
次要结局
- Child Subjective Executive Function(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Parent Behavioral Functioning - Depression(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Child Behavioral Functioning - Overall(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Parent Body Mass Index(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Parent Behavioral Functioning - Anxiety(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Child Body Mass Index Z-Score(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
- Parent Subjective Executive Function(Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks))
研究者
Marissa Gowey
Assistant Professor
University of Alabama at Birmingham