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ObesityONTIME-JRNCT02895282

Chronobiology and Childhood Obesity in a Mediterranean Spanish Population

An observational study of Obesity and Chronobiology Disorders, run by Universidad de Murcia at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Chronobiology Disorders
How many people
500 participants
Where
2 sitesSpain
Study dates
Oct 2014to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

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

Who cannot join

  • Children who take melatonin or sleep drugs

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Chronobiology laboratory, Department of Physiology

    Murcia, 30100

  • University of Murcia

    Murcia, 30100

Other trials in Spain

About this study

Official title: Chronobiology and Childhood Obesity in a Mediterranean Spanish Population (ONTIME-JR: Obesity, Nutrigenomics, Timing, Mediterranean, Junior)

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.

Read the detailed description

Childhood obesity has more than doubled in children and tripled in adolescents in the past 30 y. As consequence, increasingly children and adolescents suffer from elevated blood pressure, impaired glucose tolerance, hyperinsulinemia, dyslipidemia. Obesity has a multifactorial etiology since there are potentially numerous contributors to its development and progression. Chronobiology, the science that studies periodic (cyclic) changes in living organisms, has been recently proposed as a new and promising topic to investigate. Alterations of circadian (24 h oscillations) system may contribute to obesity and its complications development such as high blood pressure, insulin resistance, altered fasting lipid profile. Conversely, in a vicious manner, obesity has been regarded as a fault in the circadian system explainable by the association with imbalances and fluctuations of hormones/genes expressions rhythms under the influence of body weight changes.

Thus, the study will examine changes in circadian rhythmicity over a week period. The primary end point will be to evaluate differences between obese/overweight and non-obese children in chronotypes and the responses of these parameters to meal patterns. In particular, non-invasive measures that are well-established determinants of chronotypes will form the core endpoints for the study. Well designed and age-appropriate questionnaires will provide further information in order to study correlations with eating, sleeping and sedentary/active behaviors.

Keywords
Obesity, Chronobiology, Circadian
Medical subject headings
Obesity, Chronobiology Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline

Secondary outcomes (17)

  1. Individual chronotype with the Munich ChronoType Questionnaire

    To assess chronotype with a questionnaire that establishes an algorithm which optimises chronotype assessment by incorporating the information on timing of sleep and wakefulness for both work and free days. The timing and duration of sleep are generally independent. However, when the two are analysed separately for work and free days, sleep duration strongly depends on chronotype. In addition, chronotype is both age- and sex-dependent.

    Measured: At baseline

  2. Wrist temperature rhythm

    Wrist temperature wireless recording is considered a reliable procedure to evaluate circadian rhythmicity, and an index to establish and follow the effects of chronotherapy in normal living subjects.

    Measured: At baseline

  3. Rest-activity rhythm

    Rest-activity rhythm as assessed using a acceleration data logger UA-004-64 (Onset Computer, Bourne, MA, USA) placed on the non-dominant arm by means of a sports band, with its x axis parallel to the humerus bone. The sensor is programmed to record data every 30 s.

    Measured: At baseline

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

    24hs record of sleep will be completed during the 7 days of the experiment. Children are instructed to keep a sleep and food diary designed by the University of Murcia Chronobiology Laboratory. The following data will be obtained for every subject on a daily basis: time to bed, time of lights off, nocturnal awakenings lasting more than 10 minutes, sleep offset, the time the participant arose.

    Measured: At baseline

  5. Salivary cortisol determinations

    Saliva for cortisol measurements is obtained before breakfast (09:00 h), lunch time (14:00 h), and bedtime (23:00 h) the 6th the 7th day of the experimental week using the Salivette system. Cortisol is measured with radioimmunoassay.

    Measured: At baseline

  6. Salivary melatonin determinations on weekends the 6th and 7th day of the experimental week

    Samples for the measurement of salivary melatonin are obtained before lunch (14:00 h) and at night (1:00 h) the 6th and 7th day of the experimental week.

    Measured: At baseline

  7. Food habits with a 7 days dietary record

    During the week of the experiment. Data will be obtained for every subject on a daily basis and they will record the variety of foods that they eat with the portion size.

    Measured: At baseline

  8. Total energy intake

    During the week of the experiment with a software designed for this purpose.

    Measured: At baseline

  9. Macronutrient distribution

    from the 7 days dietary record, with a software designed for this purpose.

    Measured: At baseline

  10. Food variety

    from the 7 days dietary record, with a software designed for this purpose.

    Measured: At baseline

  11. Glycemic Index

    from the 7 days dietary record, with a software designed for this purpose.

    Measured: At baseline

  12. Physical activity

    from the 7 days dietary record, with a software designed for this purpose.

    Measured: Through study completion

  13. Mediterranean Diet Score

    From the 7 days dietary record, with a software designed for this purpose.

    Measured: At baseline

  14. Food timing with a 7 days dietary record

    Children will be instructed to keep a food diary. Data will be obtained for every subject on a daily basis and they will record the time of the three main meals (breakfast, lunch, and dinner).

    Measured: At baseline

  15. Light determination

    During the week of the experiment with a light detector device in the neck of the children.

    Measured: At baseline

  16. DNA collection in saliva

    Saliva will be collected to further extraction of DNA the 7th day of the experimental week.

    Measured: At baseline

  17. Saliva collection for microflora determinations

    Saliva Collection Method is the SalivaBio Oral Swab the 7th day of the experimental week.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2016 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02895282
Sponsor's protocol ID
SAF2014-52480-R
Acronym
ONTIME-JR
Status last verified
Mar 2020
First submitted
30 Jun 2016
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 33249510

  • 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.

    PubMed 29609867

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Chronobiology Disorders, run by Universidad de Murcia at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (time frame: At baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02895282, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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