NCT03764579

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2020

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

November 30, 2018

Last Update Submit

December 4, 2018

Conditions

Childhood ObesityLife StyleCircadian Rhythms

Outcome Measures

Primary Outcomes (1)

  • Body mass index measurement, percentile for age and sex

    comparative measurements prior after intervention

    6 months

Secondary Outcomes (1)

  • melatonin concentration profile in saliva

    6 months

Study Arms (2)

sleep and diet intervention

ACTIVE COMPARATOR
Behavioral: sleep and diet intervention vs diet intervention

diet intervention

ACTIVE COMPARATOR
Behavioral: sleep and diet intervention vs diet intervention

Interventions

sleep and diet intervention vs diet interventionBEHAVIORAL

lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.

diet interventionsleep and diet intervention

Eligibility Criteria

Age7 Years - 14 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children between 7 and 14 years old
  • overweight or obese (Body Mass Index superior to 97th percentile for age and sex).

You may not qualify if:

  • Medicine intake,
  • hyperactivity,
  • infectious inflammatory processes,
  • elite athletes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pilar Codoñer Franch

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Sleep

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatrics, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

November 30, 2018

First Posted

December 5, 2018

Study Start

November 29, 2018

Primary Completion

November 29, 2019

Study Completion

November 29, 2020

Last Updated

December 5, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)