NCT02895282

Brief Summary

The main objective is to investigate chronobiological aspects of childhood obesity studying the potential relationship between meal patterns and circadian rhythmicity in a cross-sectional sample of obese, overweight and normal weight children/adolescent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

October 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

June 30, 2016

Last Update Submit

March 23, 2020

Conditions

Keywords

ObesityChronobiologyCircadian

Outcome Measures

Primary Outcomes (1)

  • BMI

    A key index for relating weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared.

    At baseline

Secondary Outcomes (17)

  • Individual chronotype with the Munich ChronoType Questionnaire

    At baseline

  • Wrist temperature rhythm

    At baseline

  • Rest-activity rhythm

    At baseline

  • Sleeping characteristics with a 7 days dietary record of night time and day time (siesta) information

    At baseline

  • Salivary cortisol determinations

    At baseline

  • +12 more secondary outcomes

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children from schools who enter voluntarily in Spanish city of Murcia, located on the Southeast coast of the Mediterranean Sea.

You may qualify if:

  • Age: 8-12 years of age
  • Children from schools in the region of Murcia (Spain) who enter voluntarily

You may not qualify if:

  • Children who take melatonin or sleep drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chronobiology laboratory, Department of Physiology

Murcia, 30100, Spain

Location

University of Murcia

Murcia, 30100, Spain

Location

Related Publications (2)

  • Qian J, Martinez-Lozano N, Tvarijonaviciute A, Rios R, Scheer FAJL, Garaulet M. Blunted rest-activity rhythms link to higher body mass index and inflammatory markers in children. Sleep. 2021 May 14;44(5):zsaa256. doi: 10.1093/sleep/zsaa256.

  • Barraco GM, Martinez-Lozano N, Vales-Villamarin C, Del Carmen Blaya M, Rios R, Madrid JA, Fardy P, Garaulet M. Circadian health differs between boys and girls as assessed by non-invasive tools in school-aged children. Clin Nutr. 2019 Apr;38(2):774-781. doi: 10.1016/j.clnu.2018.03.001. Epub 2018 Mar 21.

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

ObesityChronobiology Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System Diseases

Study Officials

  • Marta Garaulet, PhD

    University of Murcia. Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor of University of Murcia

Study Record Dates

First Submitted

June 30, 2016

First Posted

September 9, 2016

Study Start

October 1, 2014

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations