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

NCT05754359 | Completed

• 1 other identifier: MHLS 22_157
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Childhood Obesity; Physical Activity

Keywords

Feasibility; Physical activity; Young Children; Intervention,

Outcome Measures

Primary Outcomes (9)

• Preschool Facilities that Agreed to Participate

  The proportion of preschools that agreed to take part in the study.(Outcome related to trial feasibility)

  10 weeks

• Preschool Retention

  The percentage of preschools which were retained throughout the study.(Outcome related to trial feasibility)

  10 weeks post baseline

• Participant Recruitment

  The expected number of participants to be recruited in this study. (Outcome related to trial feasibility).

  10 weeks

• Participants Retention

  The proportion of participants who will complete outcome assessments In either (intervention and control group).(Outcome related to trial feasibility).

  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)

  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.

  10 weeks after baseline

• Damaged or Lost ActiGraph Accelerometers-GT3X

  Number of ActiGraph accelerometers-GT3X that may loss or damage during this study

  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).

  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).

  1 week after the end of the intervention

Secondary Outcomes (3)

• Change in Body Mass Index (BMI z-score) Measurement

  Baseline and 10 weeks post-intervention

• Change in Participants Physical Activity from Baseline to Post-intervention

  Baseline and 10 weeks post-intervention

• Change in Participants Sedentary Behaviour from Baseline to Post-intervention

  Baseline and 10 weeks post-intervention

Study Arms (2)

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

EXPERIMENTAL

Preschool where the intervention implement will be run.

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.

Interventions

I'm an Active Hero (IAAH) Intervention Program 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.

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

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

General Administration of Education in Taif-KSA

Ta'if, Maccha, 26523, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 38756888 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Neil Heron, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neil Heron

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 3, 2023
• Study Start: February 12, 2023
• Primary Completion: April 30, 2023
• Study Completion: May 10, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)