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Completed

NCT Number: NCT02779647

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The intervention consisted of physical activity based on play

Behavioral

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.

Primary outcomes

  1. Children's body composition

    Time frame: 12 months

    The children's body composition was measured before and after the intervention, by bioelectrical impedance and using the InBody 720 body composition analyser.

Secondary outcomes

  1. The level of daily physical activity

    Time frame: 1 month

    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.

  2. Sleep apnea

    Time frame: 6 month

    Sleep apnea has been measured by sleep polygraphy.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Acronym: Kids-Play

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 20, 2016
Registry last updated
Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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