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

Primary Purpose

Childhood Obesity, Sleep Apnea in Obese Children, Studying Maternal and Family Factors That Cause Obesity in Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The intervention consisted of physical activity based on play
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Overweight, obesity, play, physical activity, accelerometry.

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study group

    Control group

    Arm Description

    Consisting of 49 children who were recommended a programme of physical activity, play and nutritional advice, for both the children and their parents

    49 children, who received only nutritional advice

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Sleep apnea
    Sleep apnea has been measured by sleep polygraphy.

    Full Information

    First Posted
    May 18, 2016
    Last Updated
    February 21, 2019
    Sponsor
    Universidad de Granada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02779647
    Brief Title
    Play as a Method to Reduce Overweight and Obesity in Children.
    Acronym
    Kids-Play
    Official Title
    Play as a Method to Reduce Overweight and Obesity in Children. Kids-Play Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    January 1, 2017 (Actual)
    Study Completion Date
    March 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Granada

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity, Sleep Apnea in Obese Children, Studying Maternal and Family Factors That Cause Obesity in Children
    Keywords
    Overweight, obesity, play, physical activity, accelerometry.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Consisting of 49 children who were recommended a programme of physical activity, play and nutritional advice, for both the children and their parents
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    49 children, who received only nutritional advice
    Intervention Type
    Behavioral
    Intervention Name(s)
    The intervention consisted of physical activity based on play
    Intervention Description
    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 Outcome Measure Information:
    Title
    Children's body composition
    Description
    The children's body composition was measured before and after the intervention, by bioelectrical impedance and using the InBody 720 body composition analyser.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    The level of daily physical activity
    Description
    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.
    Time Frame
    1 month
    Title
    Sleep apnea
    Description
    Sleep apnea has been measured by sleep polygraphy.
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31947884
    Citation
    Sanchez-Lopez AM, Menor-Rodriguez MJ, Sanchez-Garcia JC, Aguilar-Cordero MJ. Play as a Method to Reduce Overweight and Obesity in Children: An RCT. Int J Environ Res Public Health. 2020 Jan 3;17(1):346. doi: 10.3390/ijerph17010346.
    Results Reference
    derived
    PubMed Identifier
    31678988
    Citation
    Aguilar-Cordero MJ, Rodriguez-Blanque R, Leon-Rios X, Exposito Ruiz M, Garcia Garcia I, Sanchez-Lopez AM. Influence of Physical Activity on Blood Pressure in Children With Overweight/Obesity: A Randomized Clinical Trial. Am J Hypertens. 2020 Feb 22;33(2):131-136. doi: 10.1093/ajh/hpz174.
    Results Reference
    derived
    Links:
    URL
    http://scielo.isciii.es/pdf/nh/v27n4/42_original31.pdf
    Description
    Original research
    URL
    http://www.nutricionhospitalaria.com/pdf/6939.pdf
    Description
    Systematic review
    URL
    http://www.aulamedica.es/nh/pdf/7680.pdf
    Description
    Systematic review
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    http://scielo.isciii.es/pdf/nh/v28n3/22original18.pdf
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    http://scielo.isciii.es/pdf/nh/v28n3/23original19.pdf

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