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

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ClinicalTrials.gov Identifier: NCT02779647
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
María José Aguilar Cordero, Universidad de Granada

Brief 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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Sleep Apnea in Obese Children Studying Maternal and Family Factors That Cause Obesity in Children Behavioral: The intervention consisted of physical activity based on play Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Play as a Method to Reduce Overweight and Obesity in Children. Kids-Play Study.
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
Consisting of 49 children who were recommended a programme of physical activity, play and nutritional advice, for both the children and their parents
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.

No Intervention: Control group
49 children, who received only nutritional advice



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: María José Aguilar Cordero, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02779647    
Other Study ID Numbers: 01052013UGR
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Keywords provided by María José Aguilar Cordero, Universidad de Granada:
Overweight, obesity, play, physical activity, accelerometry.
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms