| CTRI Number |
CTRI/2012/12/003164 [Registered on: 03/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
27/11/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Health Promoting lifestyle intervention on Manipuri and Non-Manipuri University Graduate Students in a North Indian City |
|
Scientific Title of Study
|
Comparison of the Impact of a Lifestyle Intervention Package on the Salutogenic Potential and Health Promoting Lifestyle of Manipuri and Non-Manipuri University Graduate Students in a North Indian City |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amarjeet Singh |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
School Of Public Health, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814472226 |
| Fax |
|
| Email |
amarminhas56@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarjeet Singh |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
School Of Public Health, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814472226 |
| Fax |
|
| Email |
amarminhas56@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonu Goel |
| Designation |
Assisstant Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
School Of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh
Assistant Professor
School Of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914208490 |
| Fax |
|
| Email |
sonugoel007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research,
Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council Of Medical Research |
| Address |
Ansari Nagar, New Delhi- 110029 |
| 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 |
| Dr Amarjeet Singh |
Chandigarh |
Room 129,Department of Community Medicine,PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9814472226
amarminhas56@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health improvement strategy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intervention Package and book |
Lectures, workshops, meetings, seminars on Yoga, spirituality, philanthropy,physical Exercise, nutritional counseling + book(focusing on diet,yoga,exercise,spirituality,philanthropy etc).Frequency qill be monthly 6 day sessions as described above. |
| Comparator Agent |
Only book |
Only book(focusing on diet,yoga,exercise,spirituality,philanthropy etc) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Both |
| Details |
All 1st and 2nd year undergraduate Manipuri and Non Manipuri students |
|
| ExclusionCriteria |
| Details |
3rd year University undergraduates of Chandigarh |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BMI, Waist circumference, dietary habits, amount of physical activity, participation in welfare activities,HPLP and SOC score will be used as outcome variables.The time taken for this data collection was one month. |
BMI, Waist circumference, dietary habits, amount of physical activity, participation in welfare activities,HPLP and SOC score will be used as outcome variables.This data will be collected over a period of one month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in attitude and personality |
Change in attitude and personality |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Community
based interventions are required to halt the trend of increasing lifestyle
diseases. College students are an appropriate section of society for such
interventions. Chandigarh
has a lot of migrant students. Migration adds additional stress on students. An
RCT will be done over 2 years in Chandigarh
to evaluate the impact of an intervention package on lifestyle and salutogenic
potential of Manipuri and Non Manipuri university graduates with the following objectives: i)
To compare the
sense of coherence (SOC) score of Manipuri graduate students in Chandigarh with their
Non Manipuri colleagues
ii) To compare the health promoting lifestyle
profile of these university graduates
iii) To
evaluate the impact of a lifestyle intervention package on SOC score and other
measurable salutogenic indicators of these university
graduates.
|