INFOB: Dietary Habits and Sleep in Childhood Obesity

Sponsor

University of Valencia (Other)

Overall Status

Unknown status

CT.gov ID

NCT03764579

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity Life Style Circadian Rhythms	Behavioral: sleep and diet intervention vs diet intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 29, 2018

Anticipated Primary Completion Date :

Nov 29, 2019

Anticipated Study Completion Date :

Nov 29, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Body mass index measurement, percentile for age and sex [6 months]
comparative measurements prior after intervention

Secondary Outcome Measures

melatonin concentration profile in saliva [6 months]
comparative measurements prior after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pilar Codoñer Franch	Valencia		Spain	46010

Sponsors and Collaborators

University of Valencia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pilar Codoñer-Franch, Head of Pediatrics, Principal Investigator, Clinical Professor, University of Valencia

ClinicalTrials.gov Identifier:

NCT03764579

Other Study ID Numbers:

University of Valencia-POG

First Posted:

Dec 5, 2018

Last Update Posted:

Dec 5, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Dec 5, 2018