Evaluability and Feasibility of the eHOOD Intervention

Evaluability and Feasibility of the eHOOD: A Multi-Component Intervention to Promote Well-being, Healthy Weight, and Lifestyle Habits Among Adolescents in Vulnerable Positions Through Gaming, Physical and Social Activities, and Education

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. What is an appropriate evaluation design for testing the eHOOD intervention?
  2. Is the evaluation design feasible in terms of outcomes, measurements, instruments, data collection procedures, and participant acceptability?
  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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Albertslund, Denmark, 2620
        • Fritidsklubben Storagergård
      • Kastrup, Denmark, 2770
        • Fritidsklubben Munkebjergvej 125

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Inability to take part in a social community

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eHOOD intervention
Participants receive the eHOOD intervention consisting of one weekly four-hour meeting for 25 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of fully completed questionnaires.
Time Frame: Baseline to end of intervention at 25 weeks.
Feasibility of evaluation design - data completeness.
Baseline to end of intervention at 25 weeks.
Proportion of participants who participate in full interviews.
Time Frame: Baseline to end of intervention at 25 weeks.
Feasibility of evaluation design - data completeness.
Baseline to end of intervention at 25 weeks.
Proportion of participants for whom complete accelerometer data are collected.
Time Frame: Baseline to end of intervention at 25 weeks.
Feasibility of evaluation design - data completeness.
Baseline to end of intervention at 25 weeks.
Participants' experiences with instruments and data collection procedures.
Time Frame: End of intervention at 25 weeks
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.
Time Frame: Start of recruitment to baseline.
Feasibility of intervention - recruitment rate.
Start of recruitment to baseline.
Percentage of participants who attend each meeting.
Time Frame: End of intervention at 25 weeks.
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.
Time Frame: Baseline
Acceptability of intervention. Assessed via qualitative interviews at intervention start.
Baseline
Participants' satisfaction with and self-rated benefits of eHOOD.
Time Frame: End of intervention at 25 weeks.
Acceptability of intervention. Assessed via qualitative interviews at end of intervention.
End of intervention at 25 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mental wellbeing measured with the 5-item World Health Organization Well-Being Index (WHO-5) from intervention start to end of intervention
Time Frame: Baseline to end of intervention at 25 weeks
The WHO-5 includes five items each scored from 0 to 5. Raw scores range from 0 to 25 and are multiplied by 4 to transform it to a percentage scale from 0-100, where the max score equivalent to optimal wellbeing is 100, 50-70 points are equivalent to the normal range of wellbeing, and a score under 50 points is equivalent to a wellbeing below the normal range.
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
Time Frame: Baseline to end of intervention at 25 weeks
The T-ILS includes three items each scored from 1 to 3. Total scores range from 3 to 9, where 9 is equivalent to the highest level of loneliness.
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
Time Frame: Baseline to end of intervention at 25 weeks.
The SENS Motion accelerometers measure movement and can distinguish between different types of movement and rest. In this study accelerometer data were categorized into the fol-lowing categories: inactivity (lying/sitting), moderate-intensity activity, high-intensity activ-ity, calm sleep, restless sleep, and number of steps. For each category, daily minutes were calculated, and weekly averages were derived for each participant.
Baseline to end of intervention at 25 weeks.
Change in number of days per week eating breakfast from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. The item was self-constructed and contains two options (yes/no). For each participant number of days with breakfast intake per week is calculated.
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.
Time Frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. The item was self-constructed and contains two options (yes/no). For each participant number of days with fast-food intake per week is calculated.
Baseline to end of intervention at 25 weeks.
Change in number of days per week eating fruits and/or vegetables from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. The item was self-constructed and contains two options (yes/no). For each participant number of days with intake of fruits and/or vegetables per week is calculated.
Baseline to end of intervention at 25 weeks.
Change in number of days per week having meals together with one's family from intervention start to end of intervention.
Time Frame: Time frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. The item was self-constructed and contains two options (yes/no). For each participant number of days with intake of one or more meals with one's family per week is calculated.
Time frame: Baseline to end of intervention at 25 weeks.
Change in number of days per week with morning sleepiness from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. Morning sleepiness is used as an indicator of unmet sleep needs. The item was self-constructed and contains three options (very sleepy/a little sleepy/not sleepy). For each participant number of days with morning sleepiness per week is calculated.
Baseline to end of intervention at 25 weeks.
Change in number of days per week with use of cigarettes/e-cigarettes from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. The item was self-constructed and contains two options (yes/no). For each participant number of days with cigarette use per week is calculated.
Baseline to end of intervention at 25 weeks.
Change in number of days per week with use of other nicotine products from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. The item was self-constructed and contains two options (yes/no). For each participant number of days with nicotine use per week is calculated.
Baseline to end of intervention at 25 weeks.
Change in number of days per week with alcohol intake from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Composite questionnaire is sent by text message to participants for seven consecutive days at baseline and end of intervention. The item was self-constructed and contains two options (yes/no). For each participant number of days with alcohol intake per week is calculated.
Baseline to end of intervention at 25 weeks.
Change in self-rated collaboration skills from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Measured with composite questionnaire. The item was borrowed from the annual well-being survey in Danish public schools and contains five options (very of-ten/often/occasionally/rarely/never).
Baseline to end of intervention at 25 weeks.
Change in self-rated communication skills from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Measured with composite questionnaire. The item was inspired by the annual wellbeing survey in Danish public schools and contains five options (very of-ten/often/occasionally/rarely/never).
Baseline to end of intervention at 25 weeks.
New friendships at end of the intervention.
Time Frame: End of intervention at 25 weeks
Self-rated and measured with composite questionnaire. The item was self-constructed and contains four options (yes, many/yes, some/yes, a few/no).
End of intervention at 25 weeks
Change in participation in organized leisure sports from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
Self-rated and measured with composite questionnaire. The item was self-constructed and contains five options (almost always/often/occasionally/rarely/not involved in leisure sports).
Baseline to end of intervention at 25 weeks.
Change in collaboration skills assessed by coach from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
The item was self-constructed and contains three options (good/average/poor).
Baseline to end of intervention at 25 weeks.
Change in communication skills assessed by coach from intervention start to end of intervention.
Time Frame: Baseline to end of intervention at 25 weeks.
The item was self-constructed and contains three options (good/average/poor).
Baseline to end of intervention at 25 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julie C Grew, PhD, Center for Clinical Research and Prevention
  • Study Director: Michaela L Schiøtz, PhD, Center for Clinical Research and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erhvervsfyrtårn Projekt 2.3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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