Childhood ObesityNCT05754359
Development and Feasibility of an Intervention to Increase Physical Activity Among Young Children
A study testing I'm an Active Hero (IAAH) Intervention Program in people with Childhood Obesity and Physical Activity, run by Queen's University, Belfast at 1 site in Saudi Arabia.
Trial summary
The aim of this study is to develop, implement, and evaluate a novel intervention to increase physical activity and reduce sedentary behaviour among pre-school children, with the ultimate goal of reducing obesity among this age group. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Physical Activity
- What is being tested?
- I'm an Active Hero (IAAH) Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Feb 2023to 10 May 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in the preschool years, ages 3 to 5, whose parents or guardians consent to their participation in the study
- An ambulatory individual who does not require physical assistance
- Children who able to follow verbal instructions
Who cannot join
- Children older than 5 years old
- Children for whom parental/caregiver consent is not provided
- Children with a concurrent medical condition that affects their ability to physically walk a certain distance or with health issues that might influence their participation in the intervention
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
General Administration of Education in Taif-KSA
Ta'if, Maccha, 26523
About this study
Official title: Feasibility of an Intervention to Promote Physical Activity in Preschool Children: A Cluster Randomised Controlled Trial
The aim of this study is to develop, implement, and evaluate a novel intervention to increase physical activity and reduce sedentary behaviour among pre-school children, with the ultimate goal of reducing obesity among this age group. This study will provide evidence-based recommendations for reducing the prevalence of obesity among preschool-aged children, and the suggestions will help improve the physical activity intervention programme in preschoolers.
Read the detailed description
The pre-school-based I'm an Active Hero (IAAH) intervention with family involvement was developed in accordance with the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The development phase consists of locating and synthesising existing evidence (such as what is already known about existing interventions) and finding and developing theories (e.g., developing a theoretical understanding of the expected process of behaviour change). The IAAH-intervention components are theory- and evidence-based; they were developed based on a comprehensive identification and evaluation of current and past community, preschool, and family-based physical activity and lifestyle change interventions, as well as recommendations from a recent systematic review and review of reviews.
Additionally, the IAAH-intervention component was informed by conducting a systematic review to identify promising intervention components, including behaviour change techniques, that are associated with interventions that were able to increase PA in the preschool age group. In addition to conducting a qualitative study with teachers and patients/guardians, investigators will also consult them on the intervention's content and duration. Investigators would consider the suggestions and ideas from the preschool practitioners' and parent/guardian focus group meetings, which will establish the meaning of PA for the two distinct stakeholder groups, their influences on this, and considerations for a future intervention. The Template for Intervention Description and Replication (TIDieR) framework was also used to set up the intervention component.
The design of the intervention will employ systematic review and qualitative phases to inform the quantitative, feasibility phase, followed by a further qualitative phase (stakeholders will be involved in the further refinement of the intervention to add richness and depth). Findings from the systematic review and qualitative work will inform the development of the IAAH intervention.
Intervention: This will be a feasibility study of a two-arm cluster-randomised controlled trial (RCT) and will consist of an intervention group and a control group with two data collection time points (i.e., baseline and post-intervention) to test the feasibility and efficacy of a 10-week "I'm an Active Hero (IAAH)" programme intervention with the aim of improving physical activity and decreasing sedentary behaviour of preschool children aged between 3 and 5 years in Taif City, Saudi Arabia.
Process evaluation: This will be a qualitative study including interviews and/or questionnaires with stakeholders (pre-school principals, teachers, classroom assistants, and parents/guardians) to determine the acceptability of the intervention from the participants' perspectives.
- Conditions
- Childhood Obesity, Physical Activity
- Being tested
- I'm an Active Hero (IAAH) Intervention Program
- Keywords
- Feasibility, Physical activity, Young Children, Intervention,
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I'm an Active Hero (IAAH) Intervention ProgramBehavioural
The "I'm an Active Hero (IAAH)" programme is a 10-week intervention aimed at increasing physical activity and decreasing sedentary behaviour in preschool-aged (aged 3-5 years) children. It is anticipated to begin in February 2023 to May 2023. Assessments will be conducted at baseline and immediately following the intervention. The IAAH-intervention will be implemented by the preschool teachers, who will have two teacher training sessions with the main researcher (myself). The IAAH-intervention involves environmental modifications (a classroom) to create areas with sufficient space for active play; classroom sessions these will be implemented for 10 weeks (a minimum of one hour per week); and parent involvement, such as the provision of parental-child interaction homework activities and written information (tip cards, posters, and newsletters). for parents on how to encourage their children to be active.
| Study group | Role | What they receive |
|---|---|---|
| I'm an Active Hero (IAAH) Intervention program (intervention group) | Experimental | Preschool where the intervention implement will be run. Receives: Behavioral: I'm an Active Hero (IAAH) Intervention Program |
| Usual physical activities (control group) | No intervention | No intervention will be delivered in the control group, and children were requested to continue their usual physical activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preschool Facilities that Agreed to Participate
The proportion of preschools that agreed to take part in the study.(Outcome related to trial feasibility)
Measured: 10 weeks
Preschool Retention
The percentage of preschools which were retained throughout the study.(Outcome related to trial feasibility)
Measured: 10 weeks post baseline
Participant Recruitment
The expected number of participants to be recruited in this study. (Outcome related to trial feasibility).
Measured: 10 weeks
Participants Retention
The proportion of participants who will complete outcome assessments In either (intervention and control group).(Outcome related to trial feasibility).
Measured: 10 weeks post baseline
Baseline Week ActiGraph Accelerometers-GT3X Return Rate at the End of the Baseline Week
Number of children who will return their ActiGraph accelerometers-GT3X at the end of baseline week on the scheduled day (all children wore the accelerometers simultaneously)
Measured: 1 week
Return of ActiGraph Accelerometers-GT3X on Time by Post-baseline Week Participants
The number of participants who will return their ActiGraph accelerometers-GT3X to the researcher on the designated day, at end of post-baseline week.
Measured: 10 weeks after baseline
Damaged or Lost ActiGraph Accelerometers-GT3X
Number of ActiGraph accelerometers-GT3X that may loss or damage during this study
Measured: 11 weeks (1 week at baseline and 10 weeks after baseline
Intervention Fidelity
Intervention fidelity will be undertaken using the teacher's logbook of the number of sessions conducted per week and structure followed in relation to classroom guides) and observing the delivery of interventions, including two sessions of physical activity and sedentary behaviour will be observed at intervention pre-school at the midpoint through the intervention. At the end of the intervention, teachers and parents will be asked to take part in focus group and /or questionnaires.(Outcome related to trial feasibility).
Measured: 10 weeks
Acceptability : Intervention Acceptance
Intervention acceptance will be assessed via a post-intervention acceptance questionnaire and/or qualitative data from a post-intervention focus group.(outcome related to trial acceptability).
Measured: 1 week after the end of the intervention
Secondary outcomes (3)
Change in Body Mass Index (BMI z-score) Measurement
Height (to 0.1cm) and weight (to 0.1kg) will be measured twice without socks or shoes, in indoor clothing. BMI will then derive, and z -scores created relative to UK1990 data.
Measured: Baseline and 10 weeks post-intervention
Change in Participants Physical Activity from Baseline to Post-intervention
The children's preschool and home physical activity will be monitored objectively using the ActiGraph accelerometers-GT3X to be worn for four consecutive days at baseline and again for four consecutive days in week 11 of the trial. The unit of measurement will be the daily mean of time spent in light, and moderate-vigorous physical activity (LMVPA).
Measured: Baseline and 10 weeks post-intervention
Change in Participants Sedentary Behaviour from Baseline to Post-intervention
The children's preschool and home sedentary behaviour will be measured objectively using the ActiGraph accelerometers-GT3X to be worn at baseline for Four consecutive days and in week 11 of the study again for four consecutive days
Measured: Baseline and 10 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start12 Feb 2023
- Primary completion30 Apr 2023
- Study completion10 May 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 Childhood ObesityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NeilHeron, Queen's University, Belfast
- Investigators
- Neil Heron, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754359
- Sponsor's protocol ID
- MHLS 22_157
- Status last verified
- Nov 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Walah MA, Donnelly M, Alhusaini AA, Heron N. Pre-school-based behaviour change intervention to increase physical activity levels amongst young children: a feasibility cluster randomised controlled trial. Front Public Health. 2024 May 2;12:1379582. doi: 10.3389/fpubh.2024.1379582. eCollection 2024.
PubMed 38756888
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Intervention to Promote Physical Activity in Preschool Children: A Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05754359
- Acronym / sponsor ID
- MHLS 22_157
- Conditions
- Childhood Obesity, Physical Activity
- Keywords
- Feasibility, Physical activity, Young Children, Intervention,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 3 Mar 2023 (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 aim of this study is to develop, implement, and evaluate a novel intervention to increase physical activity and reduce sedentary behaviour among pre-school children, with the ultimate goal of reducing obesity among this age group. This study will provide evidence-based recommendations for reducing the prevalence of obesity among preschool-aged children, and the suggestions will help improve the physical activity intervention programme in preschoolers.
Detailed description
The pre-school-based I'm an Active Hero (IAAH) intervention with family involvement was developed in accordance with the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The development phase consists of locating and synthesising existing evidence (such as what is already known about existing interventions) and finding and developing theories (e.g., developing a theoretical understanding of the expected process of behaviour change). The IAAH-intervention components are theory- and evidence-based; they were developed based on a comprehensive identification and evaluation of current and past community, preschool, and family-based physical activity and lifestyle change interventions, as well as recommendations from a recent systematic review and review of reviews.
Additionally, the IAAH-intervention component was informed by conducting a systematic review to identify promising intervention components, including behaviour change techniques, that are associated with interventions that were able to increase PA in the preschool age group. In addition to conducting a qualitative study with teachers and patients/guardians, investigators will also consult them on the intervention's content and duration. Investigators would consider the suggestions and ideas from the preschool practitioners' and parent/guardian focus group meetings, which will establish the meaning of PA for the two distinct stakeholder groups, their influences on this, and considerations for a future intervention. The Template for Intervention Description and Replication (TIDieR) framework was also used to set up the intervention component.
The design of the intervention will employ systematic review and qualitative phases to inform the quantitative, feasibility phase, followed by a further qualitative phase (stakeholders will be involved in the further refinement of the intervention to add richness and depth). Findings from the systematic review and qualitative work will inform the development of the IAAH intervention.
Intervention: This will be a feasibility study of a two-arm cluster-randomised controlled trial (RCT) and will consist of an intervention group and a control group with two data collection time points (i.e., baseline and post-intervention) to test the feasibility and efficacy of a 10-week "I'm an Active Hero (IAAH)" programme intervention with the aim of improving physical activity and decreasing sedentary behaviour of preschool children aged between 3 and 5 years in Taif City, Saudi Arabia.
Process evaluation: This will be a qualitative study including interviews and/or questionnaires with stakeholders (pre-school principals, teachers, classroom assistants, and parents/guardians) to determine the acceptability of the intervention from the participants' perspectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I'm an Active Hero (IAAH) Intervention program (intervention group) | Experimental | Behavioral: I'm an Active Hero (IAAH) Intervention ProgramPreschool where the intervention implement will be run. |
| Usual physical activities (control group) | No intervention | –No intervention will be delivered in the control group, and children were requested to continue their usual physical activities. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children in the preschool years, ages 3 to 5, whose parents or guardians consent to their participation in the study
- An ambulatory individual who does not require physical assistance
- Children who able to follow verbal instructions
Key exclusion criteria (3 listed)
- Children older than 5 years old
- Children for whom parental/caregiver consent is not provided
- Children with a concurrent medical condition that affects their ability to physically walk a certain distance or with health issues that might influence their participation in the intervention
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 |
|---|---|---|
| I'm an Active Hero (IAAH) Intervention ProgramThe "I'm an Active Hero (IAAH)" programme is a 10-week intervention aimed at increasing physical activity and decreasing sedentary behaviour in preschool-aged (aged 3-5 years) children. It is anticipated to begin in February 2023 to May 2023. Assessments will be conducted at baseline and immediately following the intervention. The IAAH-intervention will be implemented by the preschool teachers, who will have two teacher training sessions with the main researcher (myself). The IAAH-intervention involves environmental modifications (a classroom) to create areas with sufficient space for active play; classroom sessions these will be implemented for 10 weeks (a minimum of one hour per week); and parent involvement, such as the provision of parental-child interaction homework activities and written information (tip cards, posters, and newsletters). for parents on how to encourage their children to be active. | Behavioural | I'm an Active Hero (IAAH) Intervention program (intervention group) |
Primary outcome
Preschool Facilities that Agreed to Participate
Time frame: 10 weeks
The proportion of preschools that agreed to take part in the study.(Outcome related to trial feasibility)
Preschool Retention
Time frame: 10 weeks post baseline
The percentage of preschools which were retained throughout the study.(Outcome related to trial feasibility)
Participant Recruitment
Time frame: 10 weeks
The expected number of participants to be recruited in this study. (Outcome related to trial feasibility).
Participants Retention
Time frame: 10 weeks post baseline
The proportion of participants who will complete outcome assessments In either (intervention and control group).(Outcome related to trial feasibility).
Baseline Week ActiGraph Accelerometers-GT3X Return Rate at the End of the Baseline Week
Time frame: 1 week
Number of children who will return their ActiGraph accelerometers-GT3X at the end of baseline week on the scheduled day (all children wore the accelerometers simultaneously)
Return of ActiGraph Accelerometers-GT3X on Time by Post-baseline Week Participants
Time frame: 10 weeks after baseline
The number of participants who will return their ActiGraph accelerometers-GT3X to the researcher on the designated day, at end of post-baseline week.
Damaged or Lost ActiGraph Accelerometers-GT3X
Time frame: 11 weeks (1 week at baseline and 10 weeks after baseline
Number of ActiGraph accelerometers-GT3X that may loss or damage during this study
Intervention Fidelity
Time frame: 10 weeks
Intervention fidelity will be undertaken using the teacher's logbook of the number of sessions conducted per week and structure followed in relation to classroom guides) and observing the delivery of interventions, including two sessions of physical activity and sedentary behaviour will be observed at intervention pre-school at the midpoint through the intervention. At the end of the intervention, teachers and parents will be asked to take part in focus group and /or questionnaires.(Outcome related to trial feasibility).
Acceptability : Intervention Acceptance
Time frame: 1 week after the end of the intervention
Intervention acceptance will be assessed via a post-intervention acceptance questionnaire and/or qualitative data from a post-intervention focus group.(outcome related to trial acceptability).
3 secondary outcomes
Change in Body Mass Index (BMI z-score) Measurement
Time frame: Baseline and 10 weeks post-intervention
Change in Participants Physical Activity from Baseline to Post-intervention
Time frame: Baseline and 10 weeks post-intervention
Change in Participants Sedentary Behaviour from Baseline to Post-intervention
Time frame: Baseline and 10 weeks post-intervention
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 15 Nov 2023.
- Derived from this study: PubMed 38756888Al-Walah MA, Donnelly M, Alhusaini AA, Heron N. Pre-school-based behaviour change intervention to increase physical activity levels amongst young children: a feasibility cluster randomised controlled trial. Front Public Health. 2024 May 2;12:1379582. doi: 10.3389/fpubh.2024.1379582. eCollection 2024.
- 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.
Neil Heron, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I'm an Active Hero (IAAH) Intervention Program in people with Childhood Obesity and Physical Activity, run by Queen's University, Belfast at 1 site in Saudi Arabia.
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 3 inclusion and 3 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
Preschool Facilities that Agreed to Participate (time frame: 10 weeks). The study lists 9 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 NCT05754359, 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 15 Nov 2023.