NCT07489365

Brief Summary

The goal of this feasibility study is to learn how to best evaluate the eHOOD intervention of-fered to adolescents in lower secondary education with psycho-social challenges. The main questions it aims to answer are:

  1. 1.What is an appropriate evaluation design for testing the eHOOD intervention?
  2. 2.Is the evaluation design feasible in terms of outcomes, measurements, instruments, data collection procedures, and participant acceptability?
  3. 3.Is the eHOOD intervention feasible and acceptable in terms of recruitment, retention of participants, and participant satisfaction and engagement? Participants will meet once a week in 25 weeks and take part in physical activity, communal cooking and dining, education in healthy lifestyle, and online gaming with instruction in a social community with peers. They will answer questionnaires and participate in interviews at the beginning and end of the intervention and their development will be assessed by the eHOOD coach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

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 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

August 19, 2025

Last Update Submit

March 23, 2026

Conditions

Keywords

feasibilityacceptabilityevaluation designadolescentsgamingmental wellbeingphysical activitysocial activityevaluability assessment

Outcome Measures

Primary Outcomes (8)

  • Proportion of fully completed questionnaires.

    Feasibility of evaluation design - data completeness.

    Baseline to end of intervention at 25 weeks.

  • Proportion of participants who participate in full interviews.

    Feasibility of evaluation design - data completeness.

    Baseline to end of intervention at 25 weeks.

  • Proportion of participants for whom complete accelerometer data are collected.

    Feasibility of evaluation design - data completeness.

    Baseline to end of intervention at 25 weeks.

  • Participants' experiences with instruments and data collection procedures.

    Acceptability of evaluation design. Assessed via qualitative interviews at end of intervention.

    End of intervention at 25 weeks

  • Number of weeks from recruitment start to enough participants are recruited.

    Feasibility of intervention - recruitment rate.

    Start of recruitment to baseline.

  • Percentage of participants who attend each meeting.

    Feasibility of intervention - retention of participants. Assessed via registration of par-ticipants' weekly attendance in Impactly platform.

    End of intervention at 25 weeks.

  • Participants' expectations and motivation for participating in eHOOD.

    Acceptability of intervention. Assessed via qualitative interviews at intervention start.

    Baseline

  • Participants' satisfaction with and self-rated benefits of eHOOD.

    Acceptability of intervention. Assessed via qualitative interviews at end of intervention.

    End of intervention at 25 weeks.

Secondary Outcomes (17)

  • Change in mental wellbeing measured with the 5-item World Health Organization Well-Being Index (WHO-5) from intervention start to end of intervention

    Baseline to end of intervention at 25 weeks

  • Change in loneliness measured with the Three-Item Loneliness Scale (T-ILS) from intervention start to end of intervention

    Baseline to end of intervention at 25 weeks

  • Change in level of physical activity and sleep length and quality from intervention start to end of intervention measured with SENS Motion accelerometers mounted on participants' thighs for seven consecutive days at baseline and end of intervention

    Baseline to end of intervention at 25 weeks.

  • Change in number of days per week eating breakfast from intervention start to end of intervention.

    Baseline to end of intervention at 25 weeks.

  • Change in number of days per week eating fast-food from intervention start to end of intervention.

    Baseline to end of intervention at 25 weeks.

  • +12 more secondary outcomes

Study Arms (1)

eHOOD intervention

EXPERIMENTAL

Participants receive the eHOOD intervention consisting of one weekly four-hour meeting for 25 weeks.

Behavioral: eHOOD

Interventions

eHOODBEHAVIORAL

Weekly meetings are hosted by the coach and one or two local pedagogues. Each meeting contains physical activity, preparation and intake of dinner, educational sessions, and gaming with instruction. Physical activities include ball games such as football, basketball, and table tennis, fitness training, traditional children's games, and coordination and reaction training. Educational sessions include teaching healthy dietary habits, sleeping habits, and exercise habits, focusing on the importance of taking care of one's body and staying fit to perform well in gaming. Gaming sessions contain training and gaming in teams. Additionally, partic-ipants are paired in teams and are given small assignments to be performed together between the weekly meetings. Communal cooking and dining are included as social and educational activities. Participants take turns preparing and serving dinner for their peers with supervi-sion from the pedagogue.

eHOOD intervention

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents in 7th to 10th grade (corresponding to lower secondary education) with psycho-social challenges such as anxiety, loneliness, school refusal, being a victim of bullying, and developmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorders (ASD).

You may not qualify if:

  • Inability to take part in a social community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fritidsklubben Storagergård

Albertslund, 2620, Denmark

Location

Fritidsklubben Munkebjergvej 125

Kastrup, 2770, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Julie C Grew, PhD

    Center for Clinical Research and Prevention

    PRINCIPAL INVESTIGATOR
  • Michaela L Schiøtz, PhD

    Center for Clinical Research and Prevention

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2025

First Posted

March 24, 2026

Study Start

October 1, 2022

Primary Completion

August 31, 2023

Study Completion

December 31, 2023

Last Updated

March 24, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations