Testing the Effectiveness of the mHealth Intervention #LIFEGOALS Targeting Health Behaviors in Early Adolescents for Promoting Mental Well-being: a Group-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- Change in Global Well-being from Baseline to Post-measurement
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of the #LIFEGOALS intervention for promoting mental health in early adolescents.
详细描述
The aim of the MOV-E-STAR project is to promote mental health in early adolescents (12-15 years) by motivating them to adopt a healthy lifestyle. Adolescents can protect their mental health by increasing physical activity, reducing sitting time, getting sufficient sleep, and taking a daily breakfast. Targeting these healthy lifestyle behaviours in young adolescents is an empowering, low-threshold approach that can create large public health effects. The MOV-E-STAR project aims to meet the need for an intervention targeting these behaviors in the adolescent population. Therefore, the mobile intervention '#LIFEGOALS' was developed in collaboration with stakeholders and users. The theory-based intervention consists of an application that includes (a) a self-regulation component for goal setting, self-monitoring and feedback, (b) a narrative in the form of short episodes from a youth daily drama for modelling, attitude change and increased engagement, and (c) an automated chat-function for social support and sustained engagement with the intervention.
The current study will test the intervention in a group-randomized controlled trial for its effects on mental well-being. Participants in the intervention group will have the #LIFEGOALS intervention installed on their phone and will be asked to use the intervention for 12 consecutive weeks. Participants in the control group will not receive an intervention but will only participate in the measurements. Outcomes will be assessed at baseline, intermittent (7 weeks after baseline) and post (13 weeks after baseline). Measures will include smart wearables and surveys.
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
盲法说明
Participants in the intervention condition will be explained that the aim of #LIFEGOALS is to help them adopt a healthy lifestyle. The link between a healthy lifestyle and mental health may come clear when using the #LIFEGOALS app, but this will not be explained to the participants at the start of the study.
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General adolescent population in first, second and third year of Belgian secondary education
- •Attending regular secondary education in a school in Flanders, Belgium, at time of data collection
- •Good understanding of Dutch
排除标准
- •Attending special needs education schools;
- •Attending education for non-Dutch speakers.
结局指标
主要结局
Change in Global Well-being from Baseline to Post-measurement
时间窗: Baseline (Week 0) and Post-measurement (Week 14)
An overall measure of well-being and health-related quality of life will be assessed with the KIDSCREEN-10 (Erhart et al. 2009). This is a valid unidimensional global health-related quality of life index (Ravens-Sieberer et al. 2010). The KIDSCREEN-10 consists of 10 items exploring the level of the adolescent's physical activity, energy and fitness, depressive moods and stressful feelings, opportunities to structure and enjoy social and leisure time and participation in social activities, quality of interaction with parent and feelings toward parents, nature of the relation with other adolescents, and cognitive capacity and satisfaction with school performance. Items are scored on a 5-point Likert scale. Sum scores range between 10 and 50, and a higher sum score indicates better health-related quality of life. This measure of global well-being is the primary outcome measure of this study.
次要结局
- Change in Psychological Well-being from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Change in Moods and Emotions from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Change in Global Well-being from Baseline to 7-week Intermittent Measurement(Baseline (Week 0) and Intermittent Measurement (Week 7))
- Change in Physical Activity (PA) from Baseline to Post-measurement(One week continuous measurement at Baseline (Week 0) and Post-measurement (Week 14))
- Change in Sedentary Behaviour (SB) from Baseline to Post-measurement(One week continuous measurement at Baseline (Week 0) and Post-measurement (Week 14))
- Change in Frequency of Taking Breakfast (BF) from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Experiential Engagement with the remaining of the app(Only in intervention group: 1 week after installation (Week 2), Intermittent measurement (Week 7), and Post-measurement (Week 14))
- Behavioral Engagement(Only in intervention group: Continuous assessment throughout the 12 weeks of intervention.)
- Change in Sleep Duration from Baseline to Post-measurement(One week continuous measurement at Baseline (Week 0) and Post-measurement (Week 14))
- Change in Social Support and Peers from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Perceived Change from Baseline to Intermittent measurement(Intermittent measurement (Week 7))
- Change in Sleep Quality from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Change in Depressive Symptoms from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Experiential Engagement with the narrative component(Only in intervention group: 1 week after installation (Week 2), Intermittent measurement (Week 7), and Post-measurement (Week 14))
- Change in Self-Perception from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Change in Resilience from Baseline to Post-measurement(Baseline (Week 0) and Post-measurement (Week 14))
- Perceived Change from Baseline to Post-measurement(Post-measurement (Week 14))