Dietary Habits and Sleep in Childhood Obesity (INFOB)

University of Valencia

Status: Unknown

Conditions: Life Style; Childhood Obesity; Circadian Rhythms

Treatments: Behavioral: sleep and diet intervention vs diet intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03764579

University of Valencia-POG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 7 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

sleep and diet intervention

Active Comparator group

Treatment:

Behavioral: sleep and diet intervention vs diet intervention

diet intervention

Active Comparator group

Treatment:

Behavioral: sleep and diet intervention vs diet intervention