NCT04719858

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

December 22, 2020

Last Update Submit

November 19, 2021

Conditions

Well-beingLife Style, HealthyResilienceDepressive Symptoms

Keywords

mHealthmental well-beingadolescentdigital behavior change interventionhealthy lifestyle

Outcome Measures

Primary Outcomes (1)

  • Change in Global Well-being from Baseline to Post-measurement

    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.

    Baseline (Week 0) and Post-measurement (Week 14)

Secondary Outcomes (17)

  • 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 Sleep Duration from Baseline to Post-measurement

    One week continuous measurement at Baseline (Week 0) and Post-measurement (Week 14)

  • Change in Sleep Quality from Baseline to Post-measurement

    Baseline (Week 0) and Post-measurement (Week 14)

  • +12 more secondary outcomes

Other Outcomes (8)

  • Age

    Baseline (Week 0)

  • Gender

    Baseline (Week 0)

  • Type of education

    Baseline (Week 0)

  • +5 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group that will install the #LIFEGOALS app.

Behavioral: #LIFEGOALS

Control

NO INTERVENTION

Control group that will not receive any intervention.

Interventions

#LIFEGOALSBEHAVIORAL

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.

Also known as: MOV-E-STAR intervention
Intervention

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 38166797DERIVED

  • 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.

    PMID: 35536640DERIVED

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Greet Cardon, Prof

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Geert Crombez, Prof

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Ann DeSmet, PhD

    Université Libre de Bruxelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Group-Randomized Control Trial with Intervention and Control group. Randomization will occur at group level (school) to avoid spillover effects between the two conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

January 22, 2021

Study Start

October 20, 2020

Primary Completion

May 31, 2021

Study Completion

June 30, 2021

Last Updated

November 22, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

During the study, only the researchers that are involved in the study will have access to the full data of the participants, only for research purposes. After the study, anonymized data will be shared with other researchers within our research group, and will be made available to other researchers upon request. After publication of the study results, the data will be made accessible on the Open Science Framework (OSF).

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The Study Protocol will be registered on OSF in January 2021. The collected data will be shared upon request for 5 years after the study has finished (June 2020). Data and statistical analyses that underlie results in a publication will be placed on OSF upon acceptation of the manuscript.
Access Criteria
Supporting information underlying results in a publication will be made publically available (OSF). Other supporting information will be made available to other researchers upon request.

Locations

BE(1)