NCT06572527

Brief Summary

This study was conducted as a non-randomized study to evaluate the effects of physical activity interventions developed with the Nurse-led Child Health Coordinated Physical Activity Program on the physical activity levels of preschool children. Research hypotheses; H1a: The anthropometric measurements of the group receiving the intervention are different from the control group. H1b: The physical activity levels of the group receiving intervention according to family reports are different from the control group

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

July 27, 2024

Last Update Submit

August 25, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • The parents' evaluation about their child's level of physical activity

    This is a survey question. Parents rate their children's level of physical activity compared to their peers. (5-point scale from much more active to much less active)

    Pre-intervention (T0) Two weeks after the end of the intervention (T1)

  • The duration of watching TV or using a computer (in a day)

    Time spent watching TV or using a computer

    Pre-intervention (T0) Two weeks after the end of the intervention (T1)

  • The status of organized planned physical activity

    This question was developed based on the recommendation of at least 60 minutes of moderate-intensity physical activity per day. The status of moderate-intensity physical activity was explained with examples, and information about the child's activity status was obtained from the family for the past week . (Yes/no question) Expert opinion was obtained for the survey questions.

    Pre-intervention (T0) Two weeks after the end of the intervention (T1)

  • Time of playing outside

    Time spent playing outside on weekdays and weekends,

    Pre-intervention (T0) Two weeks after the end of the intervention (T1)

  • The frequency of some activities

    Number of activities per week (ranging from never to more than 3 times per week). This survey question is in accordance with the Department of Health and Human Services recommendation.

    Pre-intervention (T0) Two weeks after the end of the intervention (T1)

  • Anthropometric measurements

    Change in body mass index, height and weight

    Pre-intervention (T0) Two weeks after the end of the intervention (T1)

Study Arms (2)

Intervention

EXPERIMENTAL

Nurse-Led Coordinated Physical Activity Program for Child Health, consisting of nurse, teacher, and family components was implemented by the researcher two days a week for six weeks. The interventions were last an average of 60 minutes each week. During this time, the nurse implemented a program, developed based on expert opinion and various guidelines, that directed students to be more active. Teachers were expected to encourage students and actively participate in the program. Families were regularly informed through the "family bulletin" and it was ensured that the program started at school was continued at home.

Behavioral: Physical Activity Program

Control

NO INTERVENTION

No intervention was applied to the control group except for the regular physical activities they perform in their school life.

Interventions

Nurse-Led Coordinated Physical Activity Program for Child Health," developed as part of the Coordinated Approach to Child Health program for preschool children.

Intervention

Eligibility Criteria

Age60 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being 5 years old
  • Being a student in kindergarten
  • Volunteer for research
  • Family consent to participate in the study
  • The teacher of the class in which the student is enrolled agrees to participate in the study

You may not qualify if:

  • Physical activity limitations due to medical conditions
  • \*After starting the study
  • Absence from the program for at least two weeks
  • If a situation arises during implementation that prevents participation in physical activity programs
  • Withdrawal of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emirdağ Fidan Ali Altıntaş Anaokulu

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityBody Weight Changes

Condition Hierarchy (Ancestors)

BehaviorBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes obtained with the questionnaire form were collected from the families by the teachers.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Non-randomized, parallel assignment (1:1)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

July 27, 2024

First Posted

August 27, 2024

Study Start

March 15, 2024

Primary Completion

May 20, 2024

Study Completion

June 5, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations