| CTRI Number |
CTRI/2018/01/011351 [Registered on: 16/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to assess effectivness of physical exercises diet modification and screen time on heignt and weight for school children studying in government schools |
|
Scientific Title of Study
|
A cluster randomaized control to assess effectivness of lifestyle intervention package on health behaviour on anthropometric measurements of school children of Daddu Majra colony and Dhanas,UT Chandigarh in 2016-2018. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Rana |
| Designation |
M Sc Nursing student |
| Affiliation |
National institute of nursing education pgimer |
| Address |
Room no 208 National institute of nursing education pgimer chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9736136565 |
| Fax |
|
| Email |
dikshar415@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita |
| Designation |
Lecturer |
| Affiliation |
National institute of nursing education pgimer |
| Address |
Room no. 305 National institute of nursing education pgimer chandigarh pin code 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872839990 |
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita |
| Designation |
Lecturer |
| Affiliation |
National institute of nursing education pgimer |
| Address |
National institute of nursing education pgimer chandigarh pin code 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872839990 |
| Fax |
|
| Email |
gaurikavita@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of nursing education pgimer chandigarh |
|
|
Primary Sponsor
|
| Name |
NINE |
| Address |
NINE pgimer chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Diksha Rana |
National institute of nursing education pgimer chandigarh |
Govt senior secondary school dhanas ang govt high school daddu majra colony UT Chandigarh
Chandigarh
CHANDIGARH |
9736136565
dikshar415@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Baseline and endline assessment was done and no intervention given to the control group |
| Intervention |
Experimental group |
Lifestyle intervention package on health behaviour which includes physical exercises diet and screen time is given to the school children and baseline and endline was done |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
School children of 7th and 8th standard
Studing in govt sr sec school
|
|
| ExclusionCriteria |
| Details |
School children with any disability illness and on leave during study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anthropometric measurment weight height body mass index waist hip ratio |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health behaviour |
3months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2017 |
| Date of Study Completion (India) |
23/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study on physical exercises diet and screen time for school children was given with the purpose to modify health behaviour towards healthy lifestyle and adopting good health behaviour as in our country physical inactivity and diet lead to various non communicable diseases in later. Findings of this study were significant in realtion to health behaviour.As this package helps school children to adopt health behaviour which shows impact on height weight body mass index and waist hip ratio. |