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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | sleep and diet intervention vs diet intervention | lifestyle 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.