Study Results
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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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-11-29
2020-11-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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sleep and diet intervention
sleep and diet intervention vs diet intervention
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
diet intervention
sleep and diet intervention vs diet intervention
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
Interventions
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sleep and diet intervention vs diet intervention
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
Eligibility Criteria
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Inclusion Criteria
* overweight or obese (Body Mass Index superior to 97th percentile for age and sex).
Exclusion Criteria
* hyperactivity,
* infectious inflammatory processes,
* elite athletes.
7 Years
14 Years
ALL
Yes
Sponsors
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University of Valencia
OTHER
Responsible Party
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Pilar Codoñer-Franch
Head of Pediatrics, Principal Investigator, Clinical Professor
Locations
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Pilar Codoñer Franch
Valencia, , Spain
Countries
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Facility Contacts
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Other Identifiers
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University of Valencia-POG
Identifier Type: -
Identifier Source: org_study_id
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