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Effect of #LIFEGOALS on Adolescents' Mental Health

NCT ID: NCT04719858

Last Updated: 2021-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Well-being Life Style, Healthy Resilience Depressive Symptoms

Keywords

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mHealth mental well-being adolescent digital behavior change intervention healthy lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

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.

Study Groups

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Intervention

Intervention group that will install the #LIFEGOALS app.

Group Type EXPERIMENTAL

#LIFEGOALS

Intervention Type BEHAVIORAL

Digital health behaviour change intervention including:

1. self-regulation component with Fitbit: goal setting, monitoring, feedback;
2. narrative component: every week participants receive a new episode (2-5 minutes) of a youth series modeling the target behaviours;
3. chatbot component: automated virtual coach that will send encouraging messages and give an automated answer to user questions.

Participants install the #LIFEGOALS app on their own mobile phone and are asked to use the app during 12 consecutive weeks. Three times per week a notification will be sent to encourage engagement with the intervention.

Control

Control group that will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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#LIFEGOALS

Digital health behaviour change intervention including:

1. self-regulation component with Fitbit: goal setting, monitoring, feedback;
2. narrative component: every week participants receive a new episode (2-5 minutes) of a youth series modeling the target behaviours;
3. chatbot component: automated virtual coach that will send encouraging messages and give an automated answer to user questions.

Participants install the #LIFEGOALS app on their own mobile phone and are asked to use the app during 12 consecutive weeks. Three times per week a notification will be sent to encourage engagement with the intervention.

Intervention Type BEHAVIORAL

Other Intervention Names

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MOV-E-STAR intervention

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agentschap Zorg en Gezondheid, Belgium

UNKNOWN

Sponsor Role collaborator

Vlaams Instituut Gezond Leven VZW

UNKNOWN

Sponsor Role collaborator

Research Foundation Flanders

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greet Cardon, Prof

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Geert Crombez, Prof

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Ann DeSmet, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles

Locations

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Ghent University

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Peuters C, Maenhout L, Cardon G, De Paepe A, DeSmet A, Lauwerier E, Leta K, Crombez G. A mobile healthy lifestyle intervention to promote mental health in adolescence: a mixed-methods evaluation. BMC Public Health. 2024 Jan 2;24(1):44. doi: 10.1186/s12889-023-17260-9.

Reference Type DERIVED
PMID: 38166797 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35536640 (View on PubMed)

Other Identifiers

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MOV-E-STAR

Identifier Type: -

Identifier Source: org_study_id