Dietary Habits and Sleep in Childhood Obesity

Study Overview
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Brief Summary
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Recruitment of obese children, classification according to sleep questionnaire and randomization in two groups to perform nutritional and sleep intervention. . One group receives dietary intervention through recommendations. A group receives dietary and sleep intervention through recommendations. An analysis of the melatonin profile and metabolic and inflammatory status is performed by biochemistry at the beginning and end of the intervention. Determine if the intervention has improved the health of obese children.

Detailed Description
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This study is carried out in children aged 7 to 14 years who are overweight or obese, in which their state and circadian rhythm variation are related by means of melatonin, biochemistry and dietary and sleep questionnaires. An intervention is performed in which patients are classified in evening and morning. After the classification, a randomized randomization is carried out in which one group receives dietary recommendations and another group receives dietary and sleep recommendations. After 6 months of follow-up the analyzes are performed again to observe possible differences with the initial values and compare it between both groups.

Official Title
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Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status

Conditions
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Childhood Obesity, Life Style, Circadian Rhythms

Intervention / Treatment
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* Behavioral: sleep and diet intervention vs diet intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children between 7 and 14 years old overweight or obese (Body Mass Index superior to 97th percentile for age and sex). Exclusion Criteria: Medicine intake, hyperactivity, infectious inflammatory processes, elite athletes.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sleep and diet intervention<br> | Behavioral: sleep and diet intervention vs diet intervention<br>* lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.<br>|
| Active Comparator: diet intervention<br> | Behavioral: sleep and diet intervention vs diet intervention<br>* lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index measurement, percentile for age and sex | comparative measurements prior after intervention | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| melatonin concentration profile in saliva | comparative measurements prior after intervention | 6 months |