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Completed

NCT Number: NCT07489365

Evaluability and Feasibility of the eHOOD Intervention

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.

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Key information

Conditions

Social Activity Behavior Loneliness Mental Wellbeing Motor Activity

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fritidsklubben Storagergård, Albertslund, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eHOOD

Behavioral

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.

Primary outcomes

  1. Proportion of fully completed questionnaires.

    Time frame: Baseline to end of intervention at 25 weeks.

    Feasibility of evaluation design - data completeness.

  2. Proportion of participants who participate in full interviews.

    Time frame: Baseline to end of intervention at 25 weeks.

    Feasibility of evaluation design - data completeness.

  3. 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.

  4. 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.

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

    Time frame: Start of recruitment to baseline.

    Feasibility of intervention - recruitment rate.

  6. 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.

  7. Participants' expectations and motivation for participating in eHOOD.

    Time frame: Baseline

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

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

Sponsors and collaborators

Lead sponsor

Center for Clinical Research and Prevention

Network

Collaborators

  • Danish Life Science Cluster
  • European Union

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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