NCT03018379

Brief Summary

Considering the increasing public health concern the obesity in Morocco, the aim of the present study was to use isotope techniques to assess body fat, total energy expenditure and physical activity to inform design and improve interventions for the prevention and control of obesity and related health risks such as diabetes and elevated blood pressure among children and adolescents. Specific objectives of the trial: 1. Determine the extent of obesity and physical activity levels in children and adolescents to design effective interventions in the school setting. 2.Propose alternative field based techniques for assessing body composition and physical activity that could be used in largescale situation assessments and in assessing interventions to address obesity and risk related health care. \* For body composition: BMI z-score, waist circumference, waist measurement at height. \* For physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the development of obesity and related health risks in schoolchildren and adolescents. 4. Collaborate with stakeholders (government, schools and / or colleges, communities and development partners) in designing interventions to address obesity and health risks. 5. To recommend to stakeholders the most effective interventions in schools to prevent and combat obesity and health risks in children and adolescents.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

December 23, 2016

Last Update Submit

January 11, 2017

Conditions

Keywords

ObesityBody compositionenergy expendituresedentaritydietary behaviors

Outcome Measures

Primary Outcomes (3)

  • Assessment of body composition using deuterium dilution technique

    Each participant provided a predose saliva sample. The postdose sample was collected from 3h to 4h after the administration of the dose.

    1 year

  • Assessment of energy expenditure using isotopes dilution techniques

    Each participant provided a predose urine sample. The postdose urine samples were collected after 3h to 4h and on days 3, 7 and 14.

    1 year

  • Assessment of physical activity levels using accelerometry triaxial (GT3X+)

    2 years 6 months

Secondary Outcomes (2)

  • Assessment of dietary intake using 24h recall questionnaire

    6 months

  • Assessment of physical activity levels using physical activity questionnaire for children (PAQ-C)

    2 years 6 months

Study Arms (3)

Assessment of body composition

The collection of the samples and the analyses were undertaken according to the guidelines of the International Atomic Energy Agency. In brief, after having emptied the bladder, each participant provided a predose saliva sample using a cotton ball.A 99.8 % deuterium dose of 0.5 g per kg body weight was given orally to the participant. The postdose sample was collected from 3h to 4h after the administration of the dose. The saliva samples were stored at 20°C until analysis by Fourier transform infrared spectroscopy (FTIR).

Assessment of energy expenditure

Each participant provided a predose urine sample. A dose of doubly labelled water 2.625 ml per kg body weight was given orally to the participant. The post dose sample was collected at 3h to 4h , and on days 3, 7 and 14 after dosing. An aliquot of those samples were stored at 20°C in tightly sealed containers until analysis by isotope-ratio mass spectrometry (IRMS).

Assessment of physical activity

The participants were instructed to wear the accelerometer triaxial (GT3X+) attached to an elasticized belt around the waist, once they woke up until bed time at night for 7 consecutive days and to remove the accelerometer any time they were to perform activities that involve the use of water and when going to bed.

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Moroccan children and adolescents recruited from public urban schools.

You may qualify if:

  • Apparently healthy
  • Aged between 8 to 14 years old

You may not qualify if:

  • Hypo or hypervolemic conditions including diet
  • Diuretics and oedema
  • Private schools
  • Rural area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivityObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Asmaa EL HAMDOUCHI, Dr

    Unité Mixte de Recherche en Nutrition, CNESTENIbn Tofail university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 12, 2017

Study Start

June 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 12, 2017

Record last verified: 2017-01