| CTRI Number |
CTRI/2017/12/011053 [Registered on: 29/12/2017] Trial Registered Prospectively |
| Last Modified On: |
24/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the Health related Quality of Life (HRQoL) and perception of body image among normal and overweight/obese adolescents |
|
Scientific Title of Study
|
A comparative study to assess the Health related Quality of Life (HRQoL) and perception of body image among normal and overweight/obese adolescents in selected English medium schools of Udupi district, Karnataka |
| Trial Acronym |
HRQOL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jane Jyothi Mathias |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India |
| Address |
M.Sc. Nursing 2nd year
Department of Child Health Nursing
Manipal College of Nursing
Manipal
Manipal College of Nursing Manipal Academy of Higher Education
Manipal-576104
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8452955934 |
| Fax |
|
| Email |
jane.mathias22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs E Binu Margaret |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India |
| Address |
Department of Child Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education,
Manipal- 576104
Karnataka
India
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binumarg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs E Binu Margaret |
| Designation |
Assistant Professor-Selection Grade |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India |
| Address |
Department of Child Health Nursing
Manipal College of Nursing
Manipal Academy of Higher Education,
Manipal- 576104
Karnataka
India
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binumarg@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jane Jyothi Mathias |
| Address |
Department of Child Health Nursing
Manipal College of Nursing Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rev Fr Mahesh DSouza |
Don Bosco English Medium High School |
Nr Our Lady of Health Church
Shirva 574 116
Udupi Dist
Karnatka
Udupi
KARNATAKA |
0820-2553320
shirvadonboscoschool@gmail.com |
| Mrs Sandhya Pradeep |
EHS Anantheswara Vadiraja school |
Thenkapete Ward No 28
Valakadu
Udupi district
Karnataka
Udupi
KARNATAKA |
0820-2521817
srianantheswara@yahoo.com |
| Mr Shiva Prasad |
EHS flower of paradise |
Flowers of Paradise Public School
Malpe 576 108
Udupi Dist
Udupi
KARNATAKA |
08202537919
info@flowersofparadise.in |
| Mrs Lakshmi |
EHS Poorna prajna |
Poornaprajna English Medium High School
Admar
Udupi district
Udupi
KARNATAKA |
08206534223
poornaprajnaemhs@gmail.com |
| Mr Palani Velu |
Jawahar Navodaya Vidyalaya Chara |
Jawahar Navodaya Vidyalaya Chara
Hebri Udupi District
Karnataka
pin- 576112
Udupi
KARNATAKA |
08253251260
jnvudupi@gmail.com |
| Ms Usha Rao |
Jnana Sudha English Medium High school |
Jayanthi Nagara Kukkundoor pin 576117
Karkala Udupi Karnataka
Udupi
KARNATAKA |
08528-211255
jnanasudhaehs@gmail.com |
| Mr Ramachandra |
KMES high school |
KMES School Road
Karkala
Karnataka 574104
Udupi
KARNATAKA |
08258230990
ramachandranellikar@gmail.com |
| Mr P Shreedhara Achar |
Sri Bhuvanendra High School |
Near Svt School Main Road Karkala Udupi Karnataka 574104
Udupi
KARNATAKA |
0820231149
principal@sribhuvanendra.org |
| Mr Devendra Nayak |
SVS English Medium High school |
Main Road
Katapadi
Udupi 574105
Udupi
KARNATAKA |
08202557528
svsemhs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Sampling criteria for Normal BMI adolescents:
1 Students studying in 8th, 9th and 10th standard from selected English medium schools of Udupi district
2 Students between the age of 13-16 years
3 Students who are present during the time of data collection and willing to participate in the study
4 BMI between 5th to 75th percentile in WHO growth chart
Sampling criteria for overweight/obese adolescents:
1 Students must be overweight or obese due to nutritional causes only
2 Students between the age of 13-16 years
3 Students studying in 8th, 9th and 10th standard from selected English medium schools of Udupi district
4 BMI more than 85th percentile in WHO growth chart
5 Students who are present during the time of data collection and willing to participate in the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related quality of life will be assessed using Pediatric Quality of Life inventory |
Data will be collected only once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body image perception will be assessed using a Rating scale on Body Image Perception |
Data will be collected only once |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "440"
Final Enrollment numbers achieved (India)="440" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2018 |
| Date of Study Completion (India) |
19/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a comparative study to assess the Health related Quality of Life (HRQoL) and perception of body image among normal and overweight or obese adolescents in selected English medium schools of Udupi district Karnataka. The purpose of the study is to get a baseline data on the HRQoL and perception of body image among the adolescents who are normal and overweight or obese as this information will help to create awareness and develop educational materials on maintenance of body weight and prevention of overweight or obesity among adolescents. The objectives of the study 1. identify the normal and overweight or obese adolescents by assessing the BMI through a screening tool 2. determine the HRQoL among normal and overweight or obese adolescents by using PedsQol 4.0 questionnaire 3. assess the perception of body image among normal and overweight or obese adolescents by using a rating scale on body image perception 4. identify the relationship between BMI and a) HRQoL b) body image perception among normal and overweight or obese adolescents 5. compare the HRQoL and body image perception among normal and overweight or obese adolescents. Data collection procedure The study will be conducted among selected students of 8th 9th and 10th standard English medium schools after obtaining the administrative permission from the respective authorities. All students will be explained about the purpose of the study. Screening of all students of 8th, 9th and 10th standard will be done by checking the height and weight. Adolescents with BMI between 5th to 75th percentile and above 85th percentile who are willing to take part in the study will be given the consent (Informed assent and participant information sheet). Informed consent for the selected students will be obtained from the parents in prior by sending the form to parents or guardian through children through the school authorities. After getting the informed consent from the parents and fixing the time from the school authorities the data regarding Health related quality of life will be collected using PedsQoL 4.0 questionnaire and body mage perception will be assessed using body image perception tool and demographic data will be collected. Data analysis Data will be analysed using descriptive and inferential statistics using SPSS v 16.0 |