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Well-beingMOV-E-STARNCT04719858

Effect of #LIFEGOALS on Adolescents' Mental Health

A study testing #LIFEGOALS in people with Well-being and Life Style, Healthy, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 11 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Well-being, Life Style, Healthy, Resilience
What is being tested?
#LIFEGOALS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
1 siteBelgium
Study dates
20 Oct 2020to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Ghent University

    Ghent, 9000

Other trials in Belgium

About this study

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

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

Read the 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.

Being tested
#LIFEGOALS
Keywords
mHealth, mental well-being, adolescent, digital behavior change intervention, healthy lifestyle
Medical subject headings
Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • #LIFEGOALSBehavioural

    Also called MOV-E-STAR intervention

    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.

Study groups in NCT04719858
Study groupRoleWhat they receive
InterventionExperimentalIntervention group that will install the #LIFEGOALS app.
Receives: Behavioral: #LIFEGOALS
ControlNo interventionControl group that will not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (17)
  1. Change in Global Well-being from Baseline to 7-week Intermittent Measurement

    An overall measure of well-being and health-related quality of life will be assessed with the KIDSCREEN-10 (Erhart et al. 2009), consisting of 10 items scored on a 5-point Likert scale. The scale explores 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. Sum scores range between 10 and 50, and a higher score indicates better health-related quality of life.

    Measured: Baseline (Week 0) and Intermittent Measurement (Week 7)

  2. Change in Physical Activity (PA) from Baseline to Post-measurement

    Average time of physical activity (PA) level (light, moderate or vigorous PA) per weekday/weekend, in minutes.

    Minutes of light, moderate and vigorous PA per day are objectively measured via Axivity trackers (accelerometers) worn at the wrist. Change in the average of light, moderate and vigorous PA from pre to post is examined for weekdays and weekend. Higher values represent more PA.

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

  3. Change in Sedentary Behaviour (SB) from Baseline to Post-measurement

    Average time seated per weekday/weekend, in minutes. Minutes of SB per day are objectively measured via Axivity trackers (accelerometers) worn at the wrist. Change in the average sedentary time from pre to post is examined for weekdays and weekend. Higher values represent more SB.

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

  4. Change in Sleep Duration from Baseline to Post-measurement

    Average time asleep per night, in hours. Sleep duration per night is objectively measured via Axivity trackers (accelerometers) worn at the wrist. Change in the average of sleep duration from pre to post is examined for nights preceding a weekday and weekend. Higher values represent more sleep.

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

  5. Change in Sleep Quality from Baseline to Post-measurement

    Sleep Quality: Average sleep quality over the past week Self-reported sleep quality will be measured in the online questionnaire via four items assessing subjective experience of sleep quality, sleep latency, sleep interruption, and daytime sleepiness. The items are based on items from 2017/18 survey of the Health Behavior in School-Aged Children (HBSC) study (Inchley, Currie, Cosma, \& Samdal, 2018) and from the Adolescent Sleep Wake Scale (ASWS; Essner et al., 2015), and are scored on a 5 point Likert scale (totally disagree - totally agree). A sum-score will be calculated (ranging from 4 to 20) with higher scores indicating better perceived sleep quality.

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

  6. Change in Frequency of Taking Breakfast (BF) from Baseline to Post-measurement

    Frequency of taking breakfast, in events per week. This is assessed via 2 items from the HBSC 2017/18 study protocol (Inchley et al. 2018): one for weekdays and one for the weekend. A sum score (ranging from 0 to 7) will indicate the average days of breakfast intake per week for the last month.

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

  7. Change in Psychological Well-being from Baseline to Post-measurement

    The subscale Psychological Well-being of the KIDSCREEN-52 will assess positive emotions and satisfaction with life. This subscale consists of 6 items scored on a 5-point Likert scale. A higher sum score (ranging from 6 to 30) indicates more happiness and more positive and satisfying views of life.

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

  8. Change in Moods and Emotions from Baseline to Post-measurement

    The subscale Moods \& Emotions from the KIDSCREEN-52 will assess the extent to which the adolescent experiences depressive moods and emotions and stressful feelings. This subscale consists of 7 items scored on a 5-point Likert scale. A higher sum score (ranging from 7 to 35) indicates a more positive mood and feelings.

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

  9. Change in Self-Perception from Baseline to Post-measurement

    The subscale Self-Perception from the KIDSCREEN-52 will be used to assess the perception of oneself as well as one's appearance (body image). This subscale consists of 5 items scored on a 5-point Likert scale. A higher sum score (ranging from 5 to 25) indicates greater self-confidence and self-satisfaction, and a more positive body image.

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

  10. Change in Social Support and Peers from Baseline to Post-measurement

    The subscale Social support \& Peers from the KIDSCREEN-27 will be used to assess the quality of interaction with friends and peers, as well as the perceived support. This subscale consists of 4 items scored on a 5-point Likert scale. A higher sum score (ranging from 4 to 20) indicate feeling more accepted and supported.

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

  11. Change in Resilience from Baseline to Post-measurement

    Resilience will be measured by the Brief Resilience Scale (BRS) (Smith, Dalen, Wiggins, Tooley, Christopher, \& Bernard, 2008). The BRS consists of 6 items scored on a 5-point Likert scale, assessing the capacity to bounce back after hard times. A higher sum score (ranging from 6 to 30) indicates greater resilience. We added a timeframe and adapted the wording of the Dutch version of the BRS (Soer et al., 2018) to make the items adequate for young adolescents. This was discussed in team, and the adapted questionnaire was tested on comprehensibility with 4 adolescents. The Dutch version of the BRS has shown sufficient reliability (α = .78) and construct validity in healthy workers (Soer et al., 2018).

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

  12. Change in Depressive Symptoms from Baseline to Post-measurement

    The Custom Short Form of the Dutch version of the PROMIS Pediatric Bank v2.0 Depressive Symptoms v2.0 (PROMIS-PedDepSx; Irwin et al., 2010) will be used to assess depressive symptoms. This scale consists of 4 items scaled on a 5-point Likert scale. A higher sum score (ranging from 4 to 20) indicates more symptoms of depression. The PROMIS-PedDepSx showed good psychometric properties (Kaat et al., 2019).

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

  13. Perceived Change from Baseline to Post-measurement

    The participants' impression of change in physical activity, sedentary time, sleep time, sleep quality and breakfast will be assessed in the online questionnaires using a one-item question for each behavior: To what extent do you do this [behavior] more or less since the start of the study? Answer options range from 1 (much less) to 5 (much more).

    Measured: Post-measurement (Week 14)

  14. Perceived Change from Baseline to Intermittent measurement

    The participants' impression of change in physical activity, sedentary time, sleep time, sleep quality and breakfast will be assessed in the online questionnaires using a one-item question for each behavior: To what extent do you do this [behavior] more or less since the start of the study? Answer options range from 1 (much less) to 5 (much more).

    Measured: Intermittent measurement (Week 7)

  15. Experiential Engagement with the narrative component

    Experiential Engagement with the narrative component of the #LIFEGOALS app refers to the user's experience when watching the episodes of the narrative.

    Self-report items are based on the 'Digital Behavior Change Intervention (DBCI) engagement scale' (Perski et al., 2019). In consultation with author O. Perski, the items were adapted and limited to 3 items assessing interest, attention and affect. Items are scaled on a 5-point Likert scale. A higher sum score (ranging from 3 to 15) indicates stronger experiential engagement with the narrative.

    Measured: Only in intervention group: 1 week after installation (Week 2), Intermittent measurement (Week 7), and Post-measurement (Week 14)

  16. Experiential Engagement with the remaining of the app

    Experiential Engagement with the remaining of the #LIFEGOALS app refers to the user's experience when using the app, not considering the narrative.

    Self-report items are based on the 'Digital Behavior Change Intervention (DBCI) engagement scale' (Perski et al., 2019). In consultation with author O. Perski, the items were adapted and limited to 4 items assessing interest, attention, affect and usability. Items are scaled on a 5-point Likert scale. A higher sum score (ranging from 4 to 20) indicates stronger experiential engagement with the rest of the app.

    Measured: Only in intervention group: 1 week after installation (Week 2), Intermittent measurement (Week 7), and Post-measurement (Week 14)

  17. Behavioral Engagement

    Behavioral Engagement with the #LIFEGOALS app refers to the actual usage of the app.

    It is assessed by logging user's activity in the app. Out of the system log data, the duration of usage will be extracted. Behavioral engagement will be reported as the average minutes of usage per week.

    Measured: Only in intervention group: Continuous assessment throughout the 12 weeks of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start20 Oct 2020
  3. Primary completion31 May 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04719858
Sponsor's protocol ID
MOV-E-STAR
Acronym
MOV-E-STAR
Status last verified
Nov 2021
First submitted
22 Dec 2020
Last updated
22 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Peuters C, DeSmet A, Maenhout L, Cardon G, Debeer D, Crombez G. Adolescent Engagement With a Multicomponent mHealth Tool: Identifying Usage Patterns, Determinants, and Health Behavior Change in an Intervention Trial. JMIR Mhealth Uhealth. 2025 Aug 18;13:e59041. doi: 10.2196/59041.

    PubMed 40825232
  • 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.

    PubMed 38166797
  • 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.

    PubMed 35536640

Questions about this trial

What is this clinical trial studying?

A study testing #LIFEGOALS in people with Well-being and Life Style, Healthy, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Global Well-being from Baseline to Post-measurement (time frame: Baseline (Week 0) and Post-measurement (Week 14)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04719858, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.

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