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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03764579
Other study ID # University of Valencia-POG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 29, 2018
Est. completion date November 29, 2020

Study information

Verified date December 2018
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date November 29, 2020
Est. primary completion date November 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 14 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Spain Pilar Codoñer Franch Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body mass index measurement, percentile for age and sex comparative measurements prior after intervention 6 months
Secondary melatonin concentration profile in saliva comparative measurements prior after intervention 6 months
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