| CTRI Number |
CTRI/2019/04/018834 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of exercise in school going children |
|
Scientific Title of Study
|
Effect of a structured multifactorial program on physical activity levels and body composition in obese and overweight adolescent |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prateek Srivastav |
| Designation |
assistant professor (senior scale) |
| Affiliation |
School of allied health sciences |
| Address |
Department of physiotherapy, Manipal Academy of higher education
Udupi
KARNATAKA
576104
India |
| Phone |
8971984556 |
| Fax |
|
| Email |
prateek.srivastav@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Prateek Srivastav |
| Designation |
assistant professor (senior scale) |
| Affiliation |
School of allied health sciences |
| Address |
Department of physiotherapy, Manipal Academy of higher education
Udupi
KARNATAKA
576104
India |
| Phone |
8971984556 |
| Fax |
|
| Email |
prateek.srivastav@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prateek Srivastav |
| Designation |
assistant professor (senior scale) |
| Affiliation |
School of allied health sciences |
| Address |
Department of physiotherapy, Manipal Academy of higher education
Udupi
KARNATAKA
576104
India |
| Phone |
8971984556 |
| Fax |
|
| Email |
prateek.srivastav@manipal.edu |
|
|
Source of Monetary or Material Support
|
| National council of educational research and training, Sri Aurobindo Marg, NCERT Campus, Adchini, New Delhi, Delhi 110016 |
|
|
Primary Sponsor
|
| Name |
National Council of Educational Research and Training |
| Address |
Sri Aurobindo Marg, NCERT Campus, Adchini, New Delhi, Delhi 110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| prateek srivastav |
kasturba Hospital |
Department of Physiotherapy, School of Allied health Sciences, MAHE,Manipal Dr, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8971984556
prateek.srivastav@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
overweight and obese adolescent |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Group A and Group B |
All the school participants will be divided into 3 group (A,B,C). The intervention period will be 12 weeks for all the group. BMI will be primary outcome measure of all the group and Diet will be secondary. The randomization will be computer generated. Questionnaires used in the study will be cross culturally validated.
Participants in the group A will receive exercise, diet education and their parents will receive lifestyle literacy.
Group B will be receive only exercise intervention |
| Comparator Agent |
group c |
Participants will continue their regular activity and eating |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
BMI higher than the 85th centile on the standard Centers for Disease Control (CDC) BMI-for-age growth charts |
|
| ExclusionCriteria |
| Details |
1) obesity due to identified genetic, metabolic or endocrine disease, they are undergoing treatment for psychiatric disorders, which are already diagnosed by the physician.
2) Unable to attend twice weekly sessions at the designated intervention locations,
3) They are assessed unsafe to participate by GP or Pediatrician
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical activity
Food intake patterns
|
baseline, post intervention (6weeks), 3 weeks, 6 weeks and 9 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body mass Index
2) Sedentary and physical activity behaviour
3) Cardiovascular fitness
4) Musculoskeletal fitness
5) Food behaviour in parents and kids
6) Mental health
7) Quality of life
8) Parental sedentary and physical activity behaviours
9) Parental mental health
10) Parental perceived autonomy and autonomous motivation
11) Family functioning
|
baseline, post intervention (6weeks), 3 weeks, 6 weeks and 9 weeks post intervention |
|
Target Sample Size
Modification(s)
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Prevention of adolescent obesity: The global picture and an Indian perspective |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
subjects were recuirted from the school. They were divided into three groups. Group A was given exercise and education about physical activity and healthy eating. Group B was given only exercise. Group C was asked to continue their regular activity. Exercise will be given for 45 minutes. sample size has been recalculate using pilot study. New sample size is n=600 (200 in each group). |