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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06265597
Other study ID # EU-SBE-DS-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date December 2, 2024

Study information

Verified date February 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date December 2, 2024
Est. primary completion date August 2, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Healthy Nutrition and Yoga Program
Healthy Nutrition Program Providing individual counseling to children every 2 weeks from the start of the program, in cooperation with a nutritionist, in line with the basic healthy eating behavior goals. In the 2nd, 4th, 6th, 8th and 10th weeks from the start of the program, children are asked to keep nutrition diaries for 2 weekdays and 1 weekend, and planning is made according to achieving basic healthy nutrition behavior goals. Sending reminder messages regarding the basic healthy eating behavior target via Whatsapp every week in order to maintain interaction and ensure motivation. Yoga Program Children's yoga is applied to each group twice a week for 12 weeks. The time points at which outcome measures will be evaluated and data reported are as follows: From the start of the program, on the 1st day, From the start of the program, in the 2nd, 4th, 6th, 8th, 10th, and 12th weeks 3 months after completion of study

Locations

Country Name City State
Turkey Karaman Provincial Directorate of National Education Karaman

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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" "2nd, 4th, 6th, 8th, 10th, 12th week immediately after the intervention" "3 months after through study completion"
Primary 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" "2nd, 4th, 6th, 8th, 10th, 12th week immediately after the intervention" "3 months after through study completion"
Primary Adolescent Identification Form The 15-item questionnaire created by the researchers includes sociodemographic data of the child. "pre-intervention"
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