|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
6 October 2015 |
|
Main ID: |
NCT02212873 |
|
Date of registration:
|
05/08/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
My Body is Fit and Fabulous at School
MyBFF@school |
|
Scientific title:
|
School-based Intervention Program - My Body is Fit and Fabulous |
|
Date of first enrolment:
|
February 2014 |
|
Target sample size:
|
332 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02212873 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Malaysia
| | | | | | | |
|
Contacts
|
|
Name:
|
Wan Nazaimoon Wan Mohamud, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institute for Medical Research, Ministry of Health Malaysia |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Classified as overweight and obese based on BMI of 85th percentile and above, according to
WHO growth chart.
No medical conditions that could endanger their health when participating in MyBFF@school.
Obtained parental and assent consents.
Exclusion Criteria:
With either physical or mental disability. With medical condition that prevents him/her to
participate in moderate-to-vigorous intensity physical activity.
With comorbidities that may interfere with the study such as diagnosed type 2 diabetes
mellitus, hypertension, nephritic syndrome, epilepsy, congenital heart disease and
skeletal anomalies.
On steroids, on anti-epileptics and on methylphenidate.
Age minimum:
7 Years
Age maximum:
16 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Overweight
|
|
Obese
|
|
Intervention(s)
|
|
Other: MyBFF@school program
|
|
Primary Outcome(s)
|
|
BMI z-score
[Time Frame: 32 weeks of intervention]
|
|
Secondary Outcome(s)
|
|
Percentage body fat
[Time Frame: 32 weeks of intervention]
|
|
Secondary ID(s)
|
|
NMRR1343916563
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|