Dietary Habits and Sleep in Childhood Obesity

Not Applicable

• Conditions: Childhood Obesity; Life Style; Circadian Rhythms
• Interventions: Behavioral: sleep and diet intervention vs diet intervention

• Registration Number: NCT03764579
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-11-29
• Study First Submitted: 2018-11-30
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05
• Primary Completion: 2019-11-29
• Study Completion: 2020-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diet intervention	sleep and diet intervention vs diet intervention	-
sleep and diet intervention	sleep and diet intervention vs diet intervention	-

Primary Outcome Measures

Name	Time	Method
Body mass index measurement, percentile for age and sex	6 months	comparative measurements prior after intervention

Secondary Outcome Measures

Name	Time	Method
melatonin concentration profile in saliva	6 months	comparative measurements prior after intervention

Trial Locations

Locations (1)

Pilar Codoñer Franch; 🇪🇸 Valencia, Spain