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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03018379
Other study ID # RAF642
Secondary ID
Status Completed
Phase N/A
First received December 23, 2016
Last updated January 11, 2017
Start date June 2013
Est. completion date January 2016

Study information

Verified date January 2017
Source Centre National De L'énergie, Des Sciences Et Techniques Nucléaires
Contact n/a
Is FDA regulated No
Health authority Morocco: Ministry of Public Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 432
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria:

- Apparently healthy

- Aged between 8 to 14 years old

Exclusion Criteria:

- Hypo or hypervolemic conditions including diet

- Diuretics and oedema

- Private schools

- Rural area

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Centre National De L'énergie, Des Sciences Et Techniques Nucléaires Ibn Tofail University, Morocco, International Atomic Energy Agency, Ministry of Education, Morocco

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary Assessment of physical activity levels using accelerometry triaxial (GT3X+) 2 years 6 months No
Secondary Assessment of dietary intake using 24h recall questionnaire 6 months No
Secondary Assessment of physical activity levels using physical activity questionnaire for children (PAQ-C) 2 years 6 months No
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