Dietary Habits and Sleep in Childhood Obesity (INFOB)
Primary Purpose
Childhood Obesity, Life Style, Circadian Rhythms
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
sleep and diet intervention vs diet intervention
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
Eligibility 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.
Sites / Locations
- Pilar Codoñer FranchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
sleep and diet intervention
diet intervention
Arm Description
Outcomes
Primary Outcome Measures
Body mass index measurement, percentile for age and sex
comparative measurements prior after intervention
Secondary Outcome Measures
melatonin concentration profile in saliva
comparative measurements prior after intervention
Full Information
NCT ID
NCT03764579
First Posted
November 30, 2018
Last Updated
December 4, 2018
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT03764579
Brief Title
Dietary Habits and Sleep in Childhood Obesity
Acronym
INFOB
Official Title
Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
November 29, 2019 (Anticipated)
Study Completion Date
November 29, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Life Style, Circadian Rhythms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sleep and diet intervention
Arm Type
Active Comparator
Arm Title
diet intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
sleep and diet intervention vs diet intervention
Intervention Description
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
Primary Outcome Measure Information:
Title
Body mass index measurement, percentile for age and sex
Description
comparative measurements prior after intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
melatonin concentration profile in saliva
Description
comparative measurements prior after intervention
Time Frame
6 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Pilar Codoñer Franch
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PILAR CODOÑER
Phone
+34 670320624
Email
pilar.codoner@uv.es
12. IPD Sharing Statement
Plan to Share IPD
No
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Dietary Habits and Sleep in Childhood Obesity
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