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

NCT ID: NCT02779647

Last Updated: 2019-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

The intervention consisted of physical activity based on play

Intervention Type 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.

Control group

49 children, who received only nutritional advice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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María José Aguilar Cordero

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 31947884 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31678988 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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01052013UGR

Identifier Type: -

Identifier Source: org_study_id

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