Dietary Habits and Sleep in Childhood Obesity

Childhood Obesity Clinical Trial

— INFOB  

Official title:

Sleep and Nutrition Intervention in Obese Children, Effects on Circadian Rhythms, Metabolic and Inflammatory Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03764579
• Other study ID #: University of Valencia-POG
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Childhood Obesity
• Circadian Rhythms
• Life Style
• Obesity
• Pediatric Obesity

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