Body CompositionNCT03018379
Body Composition, Dietary Behaviors, Energy Expenditure and Physical Activity Among Moroccan Schoolchildren and Adolescents
An observational study of Body Composition and Physical Activity, run by Centre National De L'énergie, Des Sciences Et Techniques Nucléaires.
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… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Physical Activity
- Type of treatment
- Pill or oral medicine
- How many people
- 432 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jan 2016
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Moroccan children and adolescents recruited from public urban schools.
Who may be able to join
- Apparently healthy
- Aged between 8 to 14 years old
Who cannot join
- Hypo or hypervolemic conditions including diet
- Diuretics and oedema
- Private schools
- Rural area
About this study
Official title: Assessment Study of Body Composition, Energy Expenditure and Physical Activity to Inform Design and Improve Interventions for the Prevention and Control of Obesity and Related Health Risks Among Schoolchildren and Adolescent Aged 8 to 14 Years in Morocco
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.
- Conditions
- Body Composition, Physical Activity
- Keywords
- Obesity, Body composition, energy expenditure, sedentarity, dietary behaviors
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Assessment of physical activity levels using accelerometry triaxial (GT3X+)
Measured: 2 years 6 months
Secondary outcomes (2)
Assessment of dietary intake using 24h recall questionnaire
Measured: 6 months
Assessment of physical activity levels using physical activity questionnaire for children (PAQ-C)
Measured: 2 years 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJun 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre National De L'énergie, Des Sciences Et Techniques Nucléaires
- Sponsor type
- Other government
- Collaborators
- Ministry of National Education, Morocco, Ibn Tofail University, Morocco, International Atomic Energy Agency
- Responsible party
- Principal investigator, Asmaa El Hamdouchi, Centre National De L'énergie, Des Sciences Et Techniques Nucléaires
- Investigators
- Asmaa EL HAMDOUCHI, Dr, Principal investigator, Unité Mixte de Recherche en Nutrition, CNESTENIbn Tofail university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018379
- Sponsor's protocol ID
- RAF642
- Status last verified
- Jan 2017
- First submitted
- 23 Dec 2016
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Study of Body Composition, Energy Expenditure and Physical Activity to Inform Design and Improve Interventions for the Prevention and Control of Obesity and Related Health Risks Among Schoolchildren and Adolescent Aged 8 to 14 Years in Morocco
- ClinicalTrials.gov ID
- NCT03018379
- Acronym / sponsor ID
- RAF642
- Conditions
- Body Composition, Physical Activity
- Keywords
- Obesity, Body composition, energy expenditure, sedentarity, dietary behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Centre National De L'énergie, Des Sciences Et Techniques NucléairesOther government
- Collaborators
- Ministry of National Education, Morocco, Ibn Tofail University, Morocco, International Atomic Energy Agency
- Study start
- Jun 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Moroccan children and adolescents recruited from public urban schools.
Key inclusion criteria (2 listed)
- Apparently healthy
- Aged between 8 to 14 years old
Key exclusion criteria (4 listed)
- Hypo or hypervolemic conditions including diet
- Diuretics and oedema
- Private schools
- Rural area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of body composition using deuterium dilution technique
Time frame: 1 year
Each participant provided a predose saliva sample. The postdose sample was collected from 3h to 4h after the administration of the dose.
Assessment of energy expenditure using isotopes dilution techniques
Time frame: 1 year
Each participant provided a predose urine sample. The postdose urine samples were collected after 3h to 4h and on days 3, 7 and 14.
Assessment of physical activity levels using accelerometry triaxial (GT3X+)
Time frame: 2 years 6 months
2 secondary outcomes
Assessment of dietary intake using 24h recall questionnaire
Time frame: 6 months
Assessment of physical activity levels using physical activity questionnaire for children (PAQ-C)
Time frame: 2 years 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa EL HAMDOUCHI, Dr principal investigator
Unité Mixte de Recherche en Nutrition, CNESTENIbn Tofail university
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition and Physical Activity, run by Centre National De L'énergie, Des Sciences Et Techniques Nucléaires.
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 4 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of body composition using deuterium dilution technique (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2017.