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NCT02779647 Clinical Trial

Play as a Method to Reduce Overweight and Obesity in Children.

Childhood Obesity Clinical Trial

— Kids-Play  

Official title:
Play as a Method to Reduce Overweight and Obesity in Children. Kids-Play Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02779647
Other study ID # 01052013UGR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date March 1, 2017

Study information
Verified date February 2019
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction Overweight and obesity are characterised by excess fat, which results in weight gain and is identified by the Body Mass Index (BMI). Studies show that overweight and obesity are the result of a complex interaction between genetic and environmental factors, which begins prenatally. Various studies have shown that physical exercise is an important component of weight loss programmes and that it also benefits the metabolic profile. Other authors have reported that greater weight loss is achieved by a programme that includes both diet and exercise, rather than either of these alone.

Aim The aim of this study is to analyse an intervention based on play as a means of improving the body composition of children with overweight or obesity.

Design / Method The design of the Kids-Play study is based on cases and controls. The study was conducted in Granada (Spain) The analysis sample of 98 children was divided into two groups: cases, consisting of 49 children, who participated in an intervention programme based on physical activity, play and nutritional advice (to both the child and the parents); and controls, another 49 children, who received only nutritional advice.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date March 1, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- Obese children that want participate in a voluntary way in the research and sign the informed consent.

Exclusion Criteria:

- Refused to participate

- Hormonal problems

- Age < 8 or >12 years

- Orthopaedic, respiratory

- Other problems

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• The intervention consisted of physical activity based on play
The intervention consisted of physical activity based on play, with four 90-minute sessions per week for nine months (the school year). The total of sessions was 144, the minimum number of sessions to consider valid that a child has completed the intervention was 115 (80%) in order to perform the minimum level of physical activity recommended for their ages. In parallel, twice-monthly theoretical and practical sessions of nutritional advice were given to the children and their families. The study group performed the physical activity and received the nutritional advice, while the control group received only the theoretical and practical sessions on nutrition.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universidad de Granada

Outcome
Type Measure Description Time frame Safety issue
Primary Children's body composition The children's body composition was measured before and after the intervention, by bioelectrical impedance and using the InBody 720 body composition analyser. 12 months
Secondary The level of daily physical activity The level of daily physical activity was assessed using ActiGraph wGT3X-BT accelerometers, which were worn on the right hip by all children in the study population for seven days, except during the hours of sleep. In this way it was possible to objectively analyse whether the study group met the WHO recommended levels of activity for their age group, and to determine the differences between cases and controls. 1 month
Secondary Sleep apnea Sleep apnea has been measured by sleep polygraphy. 6 month
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