The Effect of Healthy Nutrition and Yoga Program on Obese Children

December 31, 2024 updated by: Dilara Şahin, TC Erciyes University

The Effect of Healthy Nutrition and Yoga Program Given to Obese Children on Nutritional Behavior, Physical Activity and Anthropometric Measurements

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The prevalence of childhood obesity as a chronic disease is rapidly increasing all over the world, including low- and middle-income countries. Literature highlights that approximately 40.1 million children worldwide are overweight and, at the same time, overweight and obesity are rapidly increasing in almost every country in the world with no signs of slowing down. According to data, it is reported that the prevalence of overweight and obesity among children has increased from 4% to 18% in the last 41 years, and the number of obese school-age children has increased from 11 million to 124 million and has increased more than 10 times. Published reports state that Turkey's childhood obesity risk score is between 70-80%. It is reported that 30% of obese children become obese when they reach adulthood. In this context, identifying and treating individuals with childhood obesity is of great importance. The basic approach in childhood obesity, which is very difficult to treat, is to focus on changeable factors such as daily physical activity and healthy nutrition in an integrated manner. Although it has been proven in the literature that healthy nutrition and physical activity strategies are effective on obesity management, it has been stated that stabilization of this management is difficult. In addition, it is advocated that a holistic approach is required in obesity management to improve long-term results and maintain fitness. Yoga, used in today's obesity, has gained increasing popularity as a mind-body practice. Yoga mind and body movement approaches have the potential to offer a holistic approach to maintaining wellness. Yoga, a lifestyle-based form of physical exercise for health and wellness, emphasizes low physical impact postures (asana), breathwork (pranayama) and meditation (dhyana), regular body stretching, mind-body awareness, and mindful concentration. The literature has reported that yoga could reduce body mass index (BMI) in overweight/obese individuals. Another study reported that regular yoga practice is associated with weight-related health behaviors that may facilitate healthy weight management, such as healthy eating and moderate or vigorous physical activity. It has been concluded in the literature that yoga reduces the BMI values of obese children and that regular yoga practices may make it easier to prevent weight gain. Although the study results show that yoga-based interventions are promising on child obesity well-designed randomized controlled studies on this subject are needed. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Karaman, Turkey, 70200
        • Karaman Provincial Directorate of National Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Children who fall outside the inclusion criteria will not take part in the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
It includes obese children who are not given a Healthy Nutrition and Yoga Programs.
Experimental: İntervention group
It includes obese children who are given Healthy Nutrition and Yoga Programs.
Other: Healthy Nutrition and Yoga Program

  • 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adolescent Identification Form
Time Frame: "pre-intervention"
The 15-item questionnaire created by the researchers includes sociodemographic data of the child.
"pre-intervention"
Anthropometric Measurements and Child Follow-up Form
Time Frame: "pre-intervention", "12th week immediately after the intervention"
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
Time Frame: "pre-intervention", "12th week immediately after the intervention"
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"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dilara Şahin, MSc, Erciyes University Health Sciences Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EU-SBE-DŞ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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