Childhood Obesity, Circadian Rhythms, Life Style
Conditions
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.
Interventions
BEHAVIORALsleep and diet intervention vs diet intervention
lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index measurement, percentile for age and sex | 6 months | comparative measurements prior after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| melatonin concentration profile in saliva | 6 months | comparative measurements prior after intervention |
Countries
Spain
Outcome results
None listed