Health4Life: A Digital Intervention to Promote Healthy Lifestyle Behaviours From the Start of Life: Protocol for a Hybrid Effectiveness-implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Intake of key dietary indicators
研究概览
简要总结
The overall aim of this project is to evaluate the effectiveness and implementation of a digital intervention to support parents to create healthy lifestyle behaviours from the start of their infant's life, in order to prevent overweight and obesity. Using a randomized controlled trial with a hybrid type I implementation-effectiveness design we will:
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evaluate the effectiveness of the 16-month Health4Life intervention on:
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Children's' dietary intake, screen time, physical activity, and sleep
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Children's body mass index (BMI) z-scores
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Parental self-efficacy
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Evaluate the cost-effectiveness of the Health4Life app.
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Evaluate and explore the implementation of the Health4Life app within primary child healthcare with regards to its:
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acceptability, appropriateness, and feasibility according to child healthcare nurses.
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satisfaction and usage by parents.
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
- None
入排标准
- 年龄范围
- 0 Months 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •0-2 month old infants at routine visits at selected child healthcare centers in Sweden.
排除标准
- •Infants diagnosed with a neurological or endocrine disorder.
- •Infants who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
- •Infants from families who will not be able understand the content of the app.
研究组 & 干预措施
Health4Life app
Receives the Health4Life app for 16 months
干预措施: Health4Life app (Behavioral)
Usual care
Receives standard care through child healthcare
结局指标
主要结局
Intake of key dietary indicators
时间窗: Post-intervention (i.e., 16 months after baseline)
Intake of dietary indicators such as fruit, vegetables, sweet snacks, savoury snacks, and sugar sweetened beverages (portions or grams per day)
Screen time
时间窗: Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline)
Time spent watching screens (min/day)
Total physical activity
时间窗: Post-intervention (i.e., 16 months after baseline)
Total number of minutes spent in physical activity (min/day) assessed with accelerometers.
Sleep
时间窗: Post-intervention (i.e., 16 months after baseline)
Total amount of time spent sleeping (min/day) measured with accelerometers.
次要结局
- BMI(Post-intervention (i.e., 16 months after baseline))
- Parental self-efficacy to promote healthy diet and physical activity behaviours in their child(Baseline, mid-intervention (i.e., 8 months after baseline), and post-intervention (i.e., 16 months after baseline))
- Satisfaction of the app (Questionnaire)(Post-intervention (i.e., 16 months after baseline))
- Satisfaction of the app (Interviews)(Post-intervention (i.e., 16 months after baseline))
- Usage of the app (Questionnaire)(Post-intervention (i.e., 16 months after baseline))
- Usage of the app (Interviews)(Post-intervention (i.e., 16 months after baseline))
- Accetability of the app(Post-intervention (i.e., 16 months after baseline))
- Approritateness of the app(Post-intervention (i.e., 16 months after baseline))
- Feasibility of the app(Post-intervention (i.e., 16 months after baseline))
- Usage of app by parents (measured objectively through the app)(Post-intervention (i.e., 16 months after baseline))
研究者
Christine Delisle Nyström
Assistant Professor, Docent
Karolinska Institutet