- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07631754
Happy Homework 2.0: Effects on 24-hour Movement Behaviours in Children
Happy Homework 2.0: Effects on 24-hour Movement Behaviours in Children - Findings From a Pilot Cluster Randomised Controlled Trial
The aim of this research is to trial a new version of Happy Homework (HH) on children and parent health outcomes. HH was previously a paper-based 8-week program designed to encourage positive eating habits, physical activity, and healthy sleep routines among children at home. By working together, investigators are aiming make sure HH is easy to use, that it reduces teachers' workload, and enable the students to easily track and engage with HH. We also hope that this will all help contribute to the students meeting 24-hour movement behaviour targets.
Children are invited to participate in the research study. In the study investigators are going to examine children's activity behaviour profiles, and the following measures will be taken:
- Physical activity levels
- Sedentary behaviours
- Sleep duration
- Body mass index (which can be self-reported by the child).
These measures will be conducted at two time-points; (1) 1 week before the intervention begins and (2) 1 week after the intervention. Should children agree to participate in the study; children will wear an accelerometer on their non-dominant wrist and a small device on their right thigh for 8 consecutive days at both time points, along with having their height and weight recorded (the child can self-report this information).
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
The purpose of this study is to implement a new version of Happy Homework (HH). Within this study the HH app will be trialled, using a cluster-randomised control trial (cluster-RCT) design, to determine its effectiveness, feasibility, and acceptability upon child health outcomes, underpinned by the 24-hour movement guidelines. HH was previously an 8-week school-based home-focussed intervention centred on the promotion of primary school children's positive dietary habits, engagement in physical activity (PA) and sleep behaviours.
The cluster- RCT will recruit 4 primary schools in South Lanarkshire (2 control and 2 intervention), with one class of children from each school recruited (n = 30 approx.). During prior co-design workshops, and from findings of an ongoing study, stakeholders (teachers, parents, and children) will help determine the duration of the homework tasks, their frequency, their contents, and the design of the app. Additionally, they will provide opinion on the duration of intervention however, it will be for a minimum of 8 weeks and no longer than 12 weeks. As such, the HH app will include up to 12 weeks of homework tasks to be completed by the children. Reminders to remain active for the remaining weekdays and weekend days will be included to encourage habitual health behaviours. Children will be measured at two points during this period: pre-intervention (1-week prior to intervention delivery) and post intervention (1 week after the intervention).
Measures within the cluster-RCT include demographic information, body mass, physical activity, sedentary behaviour and sleep.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
South Lanarkshire
-
Blantyre, South Lanarkshire, Yhdistynyt kuningaskunta, G720LH
- The University of the West of Scotland
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- children aged 8-12 years old. Hold the ability to carry out homework tasks via digital platform, mostly independently.
Exclusion Criteria:
- children outwith the age range.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Happy Homework Arm
The participants randomised to receive the Happy Homework intervention.
|
Group to receive the Happy Homework 2.0 intervention which assessed physical activity, sedentary behaviour and sleep.
Muut nimet:
|
|
Ei väliintuloa: Control arm
Group continue on as normal receiving no intervention.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Feasibility of the Happy Homework 2.0 App
Aikaikkuna: Baseline and 8 weeks.
|
The feasibility of the program was evaluated through recruitment, retention and attrition rates.
Recruitment rate was equated by calculating the percentage of children present at baseline testing out of those who were eligible at participating schools.
Attrition rate was estimated by analysing the overall drop-out rate, and differences between the control and intervention groups at post-intervention.
|
Baseline and 8 weeks.
|
|
Usability of the Happy Homework 2.0 App
Aikaikkuna: Tracked from baseline to 8 weeks.
|
Usability was measured via uptake and engagement of the HH 2.0 activities tracked via Google analytics.
|
Tracked from baseline to 8 weeks.
|
|
Acceptability of the Happy Homework 2.0 App
Aikaikkuna: Tracked from baseline to 8 weeks.
|
Intervention acceptability was computed by considering HH activity completion.
Completion rate of activities was recorded within the HH app.
|
Tracked from baseline to 8 weeks.
|
|
Acceptability of the Happy Homework 2.0 App
Aikaikkuna: At 8 weeks.
|
Acceptability was further evaluated through post-intervention feedback questionnaires provided to participating children, their parents/carers and classroom teachers.
Items capturing perception of engagement, usability and areas for improvement were gathered using a 5-point Likert scale, with two open-text statements also included.
The Likert scale was based on 1 (strongly disagree) to 5 (strongly agree), with three different variations used for teachers, parents and children to ensure appropriateness and contextual relevance.
|
At 8 weeks.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
To assess the efficacy of the Happy Homework 2.0 app for improving 24-hour movement behaviours - physical activity.
Aikaikkuna: At baseline and again at 8 weeks.
|
Using an actiPAL 4 monitor, physical activity (MVPA, stepping time, step count) was measured.
|
At baseline and again at 8 weeks.
|
|
To assess the efficacy of the Happy Homework 2.0 app for improving 24-hour movement behaviours - sedentary behaviour.
Aikaikkuna: At baseline and again at 8 weeks.
|
Using an actiPAL 4 monitor sedentary behaviour (sit-to-stand transitions, sitting time, sedentary time, standing time) was measured.
|
At baseline and again at 8 weeks.
|
|
To assess the efficacy of the Happy Homework 2.0 app for improving 24-hour movement behaviours - sleep.
Aikaikkuna: At baseline and again at 8 weeks.
|
Using an actiPAL 4 monitor sleep (sleep duration) was measured.
Children were also asked to record sleep and wake times as a method of self-reported sleep duration.
|
At baseline and again at 8 weeks.
|
|
To examine the efficacy of the Happy Homework 2.0 app in changing levels of motivation via basic psychological need satisfaction.
Aikaikkuna: At baseline and again at 8 weeks.
|
Changes in motivation were measured through changes in basic psychological need satisfaction via questionnaires.
Questions were taken and adapted from established scales as there was no single validated questionnaire available.
A fourteen-item questionnaire was used containing a 5-point Likert scale, based on 1 (really untrue) to 5 (really true) for children to complete.
|
At baseline and again at 8 weeks.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 17984
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .