Clinical Trials Directory

Trials / Unknown

UnknownNCT03764579

Dietary Habits and Sleep in Childhood Obesity

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
University of Valencia · Academic / Other
Sex
All
Age
7 Years – 14 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALsleep and diet intervention vs diet interventionlifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.

Timeline

Start date
2018-11-29
Primary completion
2019-11-29
Completion
2020-11-29
First posted
2018-12-05
Last updated
2018-12-05

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03764579. Inclusion in this directory is not an endorsement.