Clinical trial NCT04719858: Effect of #LIFEGOALS on Adolescents' Mental Health
Official title: Testing the Effectiveness of the mHealth Intervention #LIFEGOALS Targeting Health Behaviors in Early Adolescents for Promoting Mental Well-being: a Group-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Life Style, Healthy
Resilience
Depressive Symptoms
Keywords: mHealth
mental well-being
adolescent
digital behavior change intervention
healthy lifestyle
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Agentschap Zorg en Gezondheid, Belgium
name: Vlaams Instituut Gezond Leven VZW
name: Research Foundation Flanders
First posted: 2021-01-22
Enrollment: 375
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group-Randomized Control Trial with Intervention and Control group. Randomization will occur at group level (school) to avoid spillover effects between the two conditions.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effectiveness of the #LIFEGOALS intervention for promoting mental health in early adolescents.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Attending special needs education schools;
* Attending education for non-Dutch speakers.

Primary outcomes:
measure: Change in Global Well-being from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
Secondary outcomes:
measure: Change in Global Well-being from Baseline to 7-week Intermittent Measurement
timeFrame: Baseline (Week 0) and Intermittent Measurement (Week 7)
measure: Change in Physical Activity (PA) from Baseline to Post-measurement
timeFrame: One week continuous measurement at Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Sedentary Behaviour (SB) from Baseline to Post-measurement
timeFrame: One week continuous measurement at Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Sleep Duration from Baseline to Post-measurement
timeFrame: One week continuous measurement at Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Sleep Quality from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Frequency of Taking Breakfast (BF) from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Psychological Well-being from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Moods and Emotions from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Self-Perception from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Social Support and Peers from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Resilience from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Change in Depressive Symptoms from Baseline to Post-measurement
timeFrame: Baseline (Week 0) and Post-measurement (Week 14)
measure: Perceived Change from Baseline to Post-measurement
timeFrame: Post-measurement (Week 14)
measure: Perceived Change from Baseline to Intermittent measurement
timeFrame: Intermittent measurement (Week 7)
measure: Experiential Engagement with the narrative component
timeFrame: Only in intervention group: 1 week after installation (Week 2), Intermittent measurement (Week 7), and Post-measurement (Week 14)
measure: Experiential Engagement with the remaining of the app
timeFrame: Only in intervention group: 1 week after installation (Week 2), Intermittent measurement (Week 7), and Post-measurement (Week 14)
measure: Behavioral Engagement
timeFrame: Only in intervention group: Continuous assessment throughout the 12 weeks of intervention.
Other outcomes:
measure: Age
timeFrame: Baseline (Week 0)
measure: Gender
timeFrame: Baseline (Week 0)
measure: Type of education
timeFrame: Baseline (Week 0)
measure: Grade
timeFrame: Baseline (Week 0)
measure: Socio-economic status
timeFrame: Baseline (Week 0)
measure: Change in Attitude from Baseline to Intermittent and Post measurement
timeFrame: Baseline (Week 0), Intermittent measurement (Week 7), and Post-measurement (Week 14)
measure: Change in Self-efficacy from Baseline to Intermittent and Post measurement
timeFrame: Baseline (Week 0), Intermittent measurement (Week 7), and Post-measurement (Week 14)
measure: Change in Intention from Baseline to Intermittent and Post measurement
timeFrame: Baseline (Week 0), Intermittent measurement (Week 7), and Post-measurement (Week 14)
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Ghent
name: Greet Cardon, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Geert Crombez, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Libre de Bruxelles
name: Ann DeSmet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maenhout L, Peuters C, Cardon G, Crombez G, DeSmet A, Compernolle S. Nonusage Attrition of Adolescents in an mHealth Promotion Intervention and the Role of Socioeconomic Status: Secondary Analysis of a 2-Arm Cluster-Controlled Trial. JMIR Mhealth Uhealth. 2022 May 10;10(5):e36404. doi: 10.2196/36404.