- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265597
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
Enrolling by invitation
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
33
Phase
- 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
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-
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Karaman, Turkey, 70200
- Karaman Provincial Directorate of National Education
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
September 14, 2022
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
December 18, 2023
First Submitted That Met QC Criteria
February 16, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 31, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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