Childhood Obesity PreventionPhase 4NCT02082080
Prevention and Control of Obesity in Primary School Children in Tehran
A Phase 4 study testing Education and Social support in people with Childhood Obesity Prevention, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
This study evaluates the effect of an interventional model for preventing and controlling overweight and obesity in male and female fifth-graders. First, based on WHO (World Health Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students from 12 primary schools (randomly allocated to… Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Childhood Obesity Prevention
- What is being tested?
- Education and Social support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteIran
- Study dates
- Dec 2012to Jun 2013
- Phase
- Phase 4
- 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI-Z-Score> or =1 (WHO)
- Students in the fifth or sixth grades
Who cannot join
- Metabolic disorders (hypo or hyperthyroidism)
- Any disease which interfere with adherence to the intervention
- Intake of any appetite-reducing drug
- Doing professional sports
- Being on a weight reduction diet
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effect of an interventional model for preventing and controlling overweight and obesity in male and female fifth-graders. First, based on WHO (World Health Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be screened. Then from the screened students 30 students with the following inclusion criteria will be recruited: not metabolically ill, not on a weight losing diet and not professionally athlete. For selected students BMI-Z score as primary outcome will be calculated. Demographic data, as well as data on waist and hip circumference, triceps skin-fold thickness, food intake for 3 days (2 ordinary week days and 1 weekend) and physical activity will be collected at the beginning and at end of the 6-month intervention. The approach of the study will be Health Promoting Schools. The intervention includes three components, i.e., nutrition education (students and parents), increased physical activity, and changing environment (food items offered in schools' canteens). Nutrition education will be imparted (a 30-minute session per week) by health instructors; physical activity will be done under the supervision of the school coaches (2 one-hour sessions per week). Parents' education (a 1.5-hour session) will be monthly. Finally the efficacy of the intervention will be determined and reported.
- Conditions
- Childhood Obesity Prevention
- Being tested
- Education, Social support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Social supportOther
| Study group | Role | What they receive |
|---|---|---|
| Obese and overweight children, education | Active comparator | Overweight and obese school children in grades 5 and 6 Receives: Other: Education; Other: Social support |
| Obese and overweight children | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain on the 11-point Short Pain Scale (SPS-11) at week 24 Change from baseline BMI (Body Mass Index) at 6 months
Measured: Baseline, month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startDec 2012
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Obesity PreventionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082080
- Sponsor's protocol ID
- adjazayery
- Status last verified
- Mar 2014
- First submitted
- 27 Dec 2013
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Control of Obesity in Primary School Children in Tehran
- ClinicalTrials.gov ID
- NCT02082080
- Acronym / sponsor ID
- adjazayery
- Conditions
- Childhood Obesity Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- First posted
- 10 Mar 2014 (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.
This study evaluates the effect of an interventional model for preventing and controlling overweight and obesity in male and female fifth-graders. First, based on WHO (World Health Organization) references obese (BMI-Z score ≥ 2) and overweight (BMI-Z score ≥ 1) students from 12 primary schools (randomly allocated to 6 intervention and 6 comparison) will be screened. Then from the screened students 30 students with the following inclusion criteria will be recruited: not metabolically ill, not on a weight losing diet and not professionally athlete. For selected students BMI-Z score as primary outcome will be calculated. Demographic data, as well as data on waist and hip circumference, triceps skin-fold thickness, food intake for 3 days (2 ordinary week days and 1 weekend) and physical activity will be collected at the beginning and at end of the 6-month intervention. The approach of the study will be Health Promoting Schools. The intervention includes three components, i.e., nutrition education (students and parents), increased physical activity, and changing environment (food items offered in schools' canteens). Nutrition education will be imparted (a 30-minute session per week) by health instructors; physical activity will be done under the supervision of the school coaches (2 one-hour sessions per week). Parents' education (a 1.5-hour session) will be monthly. Finally the efficacy of the intervention will be determined and reported.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese and overweight children, education | Active comparator | Other: Education, Other: Social supportOverweight and obese school children in grades 5 and 6 |
| Obese and overweight children | No intervention | – |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- BMI-Z-Score> or =1 (WHO)
- Students in the fifth or sixth grades
Key exclusion criteria (5 listed)
- Metabolic disorders (hypo or hyperthyroidism)
- Any disease which interfere with adherence to the intervention
- Intake of any appetite-reducing drug
- Doing professional sports
- Being on a weight reduction diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education | Other | Obese and overweight children, education |
| Social support | Other | Obese and overweight children, education |
Primary outcome
Change from baseline in pain on the 11-point Short Pain Scale (SPS-11) at week 24 Change from baseline BMI (Body Mass Index) at 6 months
Time frame: Baseline, month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Education and Social support in people with Childhood Obesity Prevention, run by Tehran University of Medical Sciences at 1 site in Iran.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change from baseline in pain on the 11-point Short Pain Scale (SPS-11) at week 24 Change from baseline BMI (Body Mass Index) at 6 months (time frame: Baseline, month 6). 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 10 Mar 2014.