| CTRI Number |
CTRI/2019/09/021452 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
31/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
To prevent the unhealthy lifestyle choices, as, unbalanced diet, physical inactivity, tobacco and alcohol use that leads to various long term diseases later in life, as, diabetes and hypertension among school going adolescents, their parents and teachers through an intervention |
|
Scientific Title of Study
|
Health Promotion Intervention Package for Prevention of Underlying Behavioral Risk Factors of Chronic Diseases: A Cluster Randomized Controlled Trial in School Settings |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Kaur |
| Designation |
PhD Scholar |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Community Medicine and School of Public Health,
Postgraduate Institute of Medical Education and Research, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826224651 |
| Fax |
|
| Email |
sandeep.kaur109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manmeet Kaur |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Community Medicine and School of Public Health,
Postgraduate Institute of Medical Education and Research, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815071863 |
| Fax |
|
| Email |
mini.manmeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manmeet Kaur |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Community Medicine and School of Public Health,
Postgraduate Institute of Medical Education and Research, Chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815071863 |
| Fax |
|
| Email |
mini.manmeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission (UGC), Bahadur Shah Zafar Marg, New Delhi- 110002, India |
|
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Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
University Grants Commission (UGC) Bahadur Shah Zafar Marg, New Delhi - 110002. |
| Type of Sponsor |
Government funding agency |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model High School, Sector 11
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model High School, Sector 12
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model Senior Secondary School, Sector 16
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model Senior Secondary School, Sector 23
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model High School, Sector 25
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model Senior Secondary School, Sector 28/D
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model High School, Sector 32
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model Senior Secondary School, Sector 35
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model High School, Sector 38/D
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model High School, Sector 43
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government Model Senior Secondary School, Sector 44
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
| Sandeep Kaur |
12 Randomly selected government schools of Chandigarh |
Government High School, Sector 51
Chandigarh
CHANDIGARH |
8826224651
sandeep.kaur109@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Reduction of risk factors of chronic diseases (unbalanced diet, physical inactivity, tobacco and alcohol use) in school going adolescents, their parents and teachers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health promotion intervention will not be given to the control arm with 6 randomly allocated clusters |
Clusters in control arm will be given pamphlets (same as intervention arm) regarding healthy dietary practices, recommended levels of physical activity & its importance and harmful effects of tobacco and alcohol use. But, they will not be given 6 months long, school based health promotion intervention package. They will be assessed in the baseline and end-line survey along with the intervention arm for the same parameters. |
| Intervention |
School based health promotion intervention |
6 clusters will be randomly (lottery method) allocated to the arm from 12 randomly selected clusters (using random number tables). The intervention arm will receive the health promotion intervention for 6 months in school setting regarding healthy dietary practices, importance of physical activity and harmful effects of tobacco and alcohol use. They will also be given the pamphlets regarding the same practices |
|
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Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adolescents: Age: 11-16 years
Adults (parents and teachers): Age below 65 years
Participants willing to give consent
Participants residing in UT Chandigarh for at least next one more year
For teachers, all teachers having interaction with the randomly selected class of a school will be included, as, all subject teachers, class teacher, mid-day meal in-charges, physical activity teachers, counsellors and medical in-charges. |
|
| ExclusionCriteria |
| Details |
Adolescents not falling in age group of 11-16 years
Adults (parents and teachers)- Age not below 65 years
Participants not willing to give consent
Participants not residing in UT Chandigarh for at least next one more year
Teachers not having direct contact with randomly selected class of school |
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Prevention of behavioral risk factors (unbalanced diet, physical inactivity, use of tobacco and alcohol) of Diabetes and Hypertension among school going adolescents, their parents & teachers in a school setting through a school based health promotion intervention |
Baseline assessment: 10-12 months
Development and implemention of intervention- 12 months
End-line assessment: 10 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of health promotion intervention on knowledge and practices, anthropometric measurements (BMI, WHR, TSFT, SSFT, MUAC and maximum hand grip strength), physiological measurement (BP) and on objective measurements (sodium excretion from 24-hour urine samples and lipids and FPG levels from blood samples) related to risk factors of diabetes & hypertension among adolescents, their parents & teachers. |
Assessment of impact on knowledge and practices: 2 months
Assessment of impact on anthropometric Measurements and physiological measurement: 2 months
Assessment of impact on objective measurements: 6-8 months |
|
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Target Sample Size
|
Total Sample Size="813"
Sample Size from India="813"
Final Enrollment numbers achieved (Total)= "940"
Final Enrollment numbers achieved (India)="940" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2019 |
| Date of Study Completion (India) |
21/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sandeep.kaur109@gmail.com].
- For how long will this data be available start date provided 31-12-2021 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Chronic
diseases like diabetes, cardiovascular diseases and cancers are on the rise.
Most of the risk factors of these diseases commence in adolescence. Therefore, a cluster randomized controlled trial
is designed to evaluate the effect of school-based health promotion
intervention on the risk factors of chronic diseases.
Considering school as a cluster, twelve
schools will be randomly selected from the public schools of Chandigarh, a city
in India. After baseline assessment, six schools will be randomly allocated to
intervention and six to control arm. Study participants will be students of 8th
grade (age 10-16 years), their parents and teachers. A sample of 360 students
(12 clusters x 30 students) has been estimated to provide statistically valid
inference.
The PRECEDE PROCEED
Model will be used for developing health promotion interventions to prevent use
of unbalanced diet, physical inactivity, alcohol, and tobacco. Interventions
will be implemented over a period of six-months in school setting. For
students, intervention will comprise of interactive learning sessions of 30
minutes duration per week and physical activity session of 30 minutes duration
four times every week. For parents and teachers, educational sessions will be
conducted for 30 minutes four times during the intervention period.
Primary outcomes will be change in prevalence
of behavioural risk factors from pre- to post-intervention. Changes in
anthropometric, physiological, and biochemical measures will be the secondary
outcomes. The difference-in-difference (DID) method
will be used to measure the net change in the outcomes.
It is important to understand whether health
promotion interventions implemented in the school setting simultaneously
targeting adolescents, their teachers and parents are effective. The use of the
PRECEDE-PROCEDE model for planning, implementing, and evaluating the
intervention as part of a cluster Randomized Controlled Trial design with DID
analysis, could provide an objective assessment of the impact.
|