Development and Feasibility of an Intervention to Increase Physical Activity Among Young Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-12

Study Completion Date

2023-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency

NCT05681832

Behavior, Child Physical Inactivity

COMPLETED NA

School Based Physical Activity Interventions and Its Impact on Wellbeing and Educational Outcomes

NCT03548350

Physical Activity Health Behavior

COMPLETED PHASE1

Child Health Coordinated Physical Activity Program

NCT06572527

Physical Activity Children, Only Nurse's Role +1 more

COMPLETED NA

Physical Activity Routines, Education, Assessment, Literacy, and Information Technology Application in Young Children

NCT06742294

Intervention Wait-List Control Healthy

ACTIVE_NOT_RECRUITING NA

Effects of a Multimodal Preference-based Parental Intervention on Preschoolers' Physical Activity Behaviour - a Cluster-randomized Trial

NCT01070251

Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity Physical Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

I'm an Active Hero (IAAH) Intervention program (intervention group)

Preschool where the intervention implement will be run.

Group Type EXPERIMENTAL

I'm an Active Hero (IAAH) Intervention Program

Intervention Type BEHAVIORAL

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.

Usual physical activities (control group)

No intervention will be delivered in the control group, and children were requested to continue their usual physical activities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

I'm an Active Hero (IAAH) Intervention Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes