Social ActivityNCT07489365
Evaluability and Feasibility of the eHOOD Intervention
A study testing eHOOD in people with Social Activity and Mental Wellbeing, run by Center for Clinical Research and Prevention at 2 sites in Denmark.
Trial 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. What is an appropriate evaluation design for testing the eHOOD intervention? 2. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Social Activity, Mental Wellbeing, Loneliness
- What is being tested?
- eHOOD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2022to 31 Dec 2023
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Inability to take part in a social community
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Fritidsklubben Storagergård
Albertslund, 2620
Fritidsklubben Munkebjergvej 125
Kastrup, 2770
About this study
Official 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
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:
- What is an appropriate evaluation design for testing the eHOOD intervention?
- Is the evaluation design feasible in terms of outcomes, measurements, instruments, data collection procedures, and participant acceptability?
- 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.
- Conditions
- Social Activity, Mental Wellbeing, Loneliness
- Being tested
- eHOOD
- Keywords
- feasibility, acceptability, evaluation design, adolescents, gaming, mental wellbeing, physical activity, social activity, evaluability assessment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHOODBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| eHOOD intervention | Experimental | Participants receive the eHOOD intervention consisting of one weekly four-hour meeting for 25 weeks. Receives: Behavioral: eHOOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of fully completed questionnaires.
Feasibility of evaluation design - data completeness.
Measured: Baseline to end of intervention at 25 weeks.
Proportion of participants who participate in full interviews.
Feasibility of evaluation design - data completeness.
Measured: Baseline to end of intervention at 25 weeks.
Proportion of participants for whom complete accelerometer data are collected.
Feasibility of evaluation design - data completeness.
Measured: 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.
Measured: End of intervention at 25 weeks
Number of weeks from recruitment start to enough participants are recruited.
Feasibility of intervention - recruitment rate.
Measured: 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.
Measured: End of intervention at 25 weeks.
Participants' expectations and motivation for participating in eHOOD.
Acceptability of intervention. Assessed via qualitative interviews at intervention start.
Measured: Baseline
Participants' satisfaction with and self-rated benefits of eHOOD.
Acceptability of intervention. Assessed via qualitative interviews at end of intervention.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline to end of intervention at 25 weeks.
Change in number of days per week eating breakfast from intervention start to end of intervention.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline to end of intervention at 25 weeks.
Change in self-rated collaboration skills from intervention start to end of intervention.
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).
Measured: Baseline to end of intervention at 25 weeks.
Change in self-rated communication skills from intervention start to end of intervention.
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).
Measured: Baseline to end of intervention at 25 weeks.
New friendships at end of the intervention.
Self-rated and measured with composite questionnaire. The item was self-constructed and contains four options (yes, many/yes, some/yes, a few/no).
Measured: End of intervention at 25 weeks
Change in participation in organized leisure sports from intervention start to end of intervention.
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).
Measured: Baseline to end of intervention at 25 weeks.
Change in collaboration skills assessed by coach from intervention start to end of intervention.
The item was self-constructed and contains three options (good/average/poor).
Measured: Baseline to end of intervention at 25 weeks.
Change in communication skills assessed by coach from intervention start to end of intervention.
The item was self-constructed and contains three options (good/average/poor).
Measured: Baseline to end of intervention at 25 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Oct 2022
- Primary completion31 Aug 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Collaborators
- Danish Life Science Cluster, European Union
- Responsible party
- Sponsor
- Investigators
- Julie C Grew, PhD, Principal investigator, Center for Clinical Research and PreventionMichaela L Schiøtz, PhD, Study director, Center for Clinical Research and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489365
- Sponsor's protocol ID
- Erhvervsfyrtårn Projekt 2.3
- Status last verified
- Jul 2025
- First submitted
- 19 Aug 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grew JC, Gotzsche N, Broberg L, Schiotz ML. Evaluability and feasibility of an intervention combining gaming and social activities to improve mental wellbeing and health behaviour in adolescents facing social challenges. BMC Pediatr. 2026 Jun 20. doi: 10.1186/s12887-026-07172-z. Online ahead of print.
PubMed 42323577
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07489365
- Acronym / sponsor ID
- Erhvervsfyrtårn Projekt 2.3
- Conditions
- Social Activity, Mental Wellbeing, Loneliness
- Keywords
- feasibility, acceptability, evaluation design, adolescents, gaming, mental wellbeing, physical activity, social activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Collaborators
- Danish Life Science Cluster, European Union
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is an appropriate evaluation design for testing the eHOOD intervention?
- Is the evaluation design feasible in terms of outcomes, measurements, instruments, data collection procedures, and participant acceptability?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eHOOD intervention | Experimental | Behavioral: eHOODParticipants receive the eHOOD intervention consisting of one weekly four-hour meeting for 25 weeks. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Inability to take part in a social community
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHOODWeekly 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. | Behavioural | eHOOD intervention |
Primary outcome
Proportion of fully completed questionnaires.
Time frame: Baseline to end of intervention at 25 weeks.
Feasibility of evaluation design - data completeness.
Proportion of participants who participate in full interviews.
Time frame: Baseline to end of intervention at 25 weeks.
Feasibility of evaluation design - data completeness.
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.
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.
Number of weeks from recruitment start to enough participants are recruited.
Time frame: Start of recruitment to baseline.
Feasibility of intervention - recruitment rate.
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.
Participants' expectations and motivation for participating in eHOOD.
Time frame: Baseline
Acceptability of intervention. Assessed via qualitative interviews at intervention start.
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.
17 secondary outcomes
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in self-rated collaboration skills from intervention start to end of intervention.
Time frame: 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.
New friendships at end of the intervention.
Time frame: 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.
Change in collaboration skills assessed by coach from intervention start to end of intervention.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 42323577Grew JC, Gotzsche N, Broberg L, Schiotz ML. Evaluability and feasibility of an intervention combining gaming and social activities to improve mental wellbeing and health behaviour in adolescents facing social challenges. BMC Pediatr. 2026 Jun 20. doi: 10.1186/s12887-026-07172-z. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie C Grew, PhD principal investigator
Center for Clinical Research and Prevention
Michaela L Schiøtz, PhD study director
Center for Clinical Research and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHOOD in people with Social Activity and Mental Wellbeing, run by Center for Clinical Research and Prevention at 2 sites in Denmark.
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 1 inclusion and 1 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Proportion of fully completed questionnaires. (time frame: Baseline to end of intervention at 25 weeks.). The study lists 8 primary outcomes in all. 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 NCT07489365, which also lists 1 linked publication.
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 24 Mar 2026.