NCT06265597

Brief Summary

This study was planned to examine the effects of a healthy nutrition and yoga program given to obese children on nutritional behavior, physical activity and anthropometric measurements.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

September 14, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

December 18, 2023

Last Update Submit

December 31, 2024

Conditions

Keywords

AnthropometryChildPhysical ActivityObesityHealthy NutritionYoga

Outcome Measures

Primary Outcomes (3)

  • Anthropometric Measurements and Child Follow-up Form

    This form, created by the researchers, includes height, weight, BMI, waist circumference, body composition device anthropometric measurements, and data on nutrition and physical activity.

    "pre-intervention", "12th week immediately after the intervention"

  • Family Nutrition and Physical Activity Scale

    The scale consists of 20 items and is evaluated on a four-point Likert type scale (1=never/almost never, 2=sometimes, 3=often, 4=very often/always).The total score obtained from the scale varies between 20-80. When comparing the total score, high scores indicate less risky family practices and child behaviors for the child's obesity, while low scores indicate high-risk family environment and practices and child behaviors.

    "pre-intervention", "12th week immediately after the intervention"

  • Adolescent Identification Form

    The 15-item questionnaire created by the researchers includes sociodemographic data of the child.

    "pre-intervention"

Study Arms (2)

Control group

NO INTERVENTION

It includes obese children who are not given a Healthy Nutrition and Yoga Programs.

İntervention group

EXPERIMENTAL

It includes obese children who are given Healthy Nutrition and Yoga Programs.

Other: Healthy Nutrition and Yoga Program

Interventions

* Healthy Nutrition Program * At the beginning of the "Healthy Nutrition and Yoga Program" by the researcher give education to families and children in 3 sessions (Importance of Nutrition in School Age, Obesity in School Age, Nutrition Recommendations for Obese Children). * Providing individual counseling to children every 2 weeks from the start of the Healthy Nutrition Program, in cooperation with a nutritionist, in line with the basic healthy eating behavior goals. * After the 2nd session of the healthy nutrition education and from the beginning of the Yoga Program, in the 2nd, 4th, 6th, 8th and 10th weeks, children are asked to keep a food diary for 2 weekdays and 1 weekend (Thursday-Friday-Saturday) and planning is made according to reaching basic healthy nutrition behavior goals. * Yoga Program \*Children's yoga is applied to each group twice a week for 12 weeks.

İntervention group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The child's body mass index is at the 85th percentile and above according to age and gender,
  • Do not have any chronic disease that may cause obesity (diabetes mellitus, hypothyroidism, etc.).
  • No neurodevelopmental delay,
  • Those who agree to participate in the study after they and their parents are informed in detail about the study will be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Provincial Directorate of National Education

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric ObesityMotor ActivityObesity

Interventions

Diet, Healthy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Dilara Şahin, MSc

    Erciyes University Health Sciences Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There is a control and intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 18, 2023

First Posted

February 20, 2024

Study Start

September 14, 2022

Primary Completion

March 1, 2025

Study Completion

June 1, 2025

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations