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Dietary Habits and Sleep in Childhood Obesity (INFOB)

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ClinicalTrials.gov Identifier: NCT03764579
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pilar Codoñer-Franch, University of Valencia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Childhood Obesity Life Style Circadian Rhythms Behavioral: sleep and diet intervention vs diet intervention Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : November 29, 2019
Estimated Study Completion Date : November 29, 2020

Arm Intervention/treatment
Active Comparator: sleep and diet intervention Behavioral: sleep and diet intervention vs diet intervention
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.

Active Comparator: diet intervention Behavioral: sleep and diet intervention vs diet intervention
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.




Primary Outcome Measures :
  1. Body mass index measurement, percentile for age and sex [ Time Frame: 6 months ]
    comparative measurements prior after intervention


Secondary Outcome Measures :
  1. melatonin concentration profile in saliva [ Time Frame: 6 months ]
    comparative measurements prior after intervention



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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764579


Locations
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Spain
Pilar Codoñer Franch Recruiting
Valencia, Spain, 46010
Contact: PILAR CODOÑER    +34 670320624    pilar.codoner@uv.es   
Sponsors and Collaborators
University of Valencia

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Responsible Party: Pilar Codoñer-Franch, Head of Pediatrics, Principal Investigator, Clinical Professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03764579     History of Changes
Other Study ID Numbers: University of Valencia-POG
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms