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
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Overweight, obesity, play, physical activity, accelerometry.
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
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
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
Learn more about this trial
Play as a Method to Reduce Overweight and Obesity in Children.
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