| CTRI Number |
CTRI/2024/09/073607 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of education for Prevention of Non-Communicable diseases among Adolescents of Lucknow |
|
Scientific Title of Study
|
Effectiveness of a School Based Health Promotion Intervention for Prevention of Non-Communicable diseases among Adolescents of Lucknow-A Quasi Experimental Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sugandha Jauhari |
| Designation |
Post MD PhD Scholar |
| Affiliation |
|
| Address |
Department of Community Medicine and Public Health, KGMU, Lucknow, UP
Lucknow UTTAR PRADESH 226003 India |
| Phone |
9651257725 |
| Fax |
|
| Email |
sugandha.jauhari@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sugandha Jauhari |
| Designation |
Post MD PhD Scholar |
| Affiliation |
|
| Address |
Department of Community Medicine and Public Health, KGMU, Lucknow, UP
UTTAR PRADESH 226003 India |
| Phone |
9651257725 |
| Fax |
|
| Email |
sugandha.jauhari@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sugandha Jauhari |
| Designation |
Post MD PhD Scholar |
| Affiliation |
|
| Address |
Department of Community Medicine and Public Health, KGMU, Lucknow, UP
UTTAR PRADESH 226003 India |
| Phone |
9651257725 |
| Fax |
|
| Email |
sugandha.jauhari@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
ICMR New Delhi |
| Address |
ICMR, New Delhi |
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sugandha Jauhari |
Lucknow |
Department of Community Medicine and Public Health, KGMU, Lucknow Lucknow UTTAR PRADESH |
9651257725
sugandha.jauhari@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICALCOMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NONE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention will be done in the comparator group |
The comparator group will be another school where we wont give any intervention ie education. The comparator group will be assessed at baseline and after 9 months follow up but no education related to prevention of NCDs will be given to them as we are giving in the intervention group. |
| Intervention |
school based health promotion module based on risk factors of NCDs |
A school-based, skill-oriented intervention will be developed for students, to deliver theme-based knowledge and activities for preventing behavioural risk factors (unhealthy diet, physical inactivity, tobacco, and alcohol use etc) of NCDs. The school-based health Promotion intervention package/module designed for the intervention group will have 4 themes with important and relevant domains covered under each theme.• The intervention phase will be for 6 months with 2 sessions of 35-40 minutes conducted every month (Total 12 sessions).Each session will have teacher led discussions at the beginning and at the end followed by peer led small group activity at the end. • Audio visual aids like power point presentation, videos and animation will be used to create awareness among the students.
• Yoga asanas will be demonstrated to the students for encouraging them to do physical activity.
• The students will be encouraged to make a health diary for writing take home messages during the intervention phase to share that information with their parents as well as for monitoring of their own diet and physical activity.An activity workbook will also be prepared for creating awareness in the various domains.
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
10-15 years of age
Studying in class 6th, 7th,8th, and 9th standard
Cooperative
Parents’ consent for their participation in the study
|
|
| ExclusionCriteria |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Change in Knowledge of the school going adolescents in the intervention as well as non-intervention group.
Change in Attitude of the school going adolescents in the intervention as well as non-intervention group.
Change or cessation of risk behaviour (unhealthy diet, physical inactivity, stress etc) of the school going adolescents in the intervention as well as non-intervention group. |
Change in Knowledge of the school going adolescents in the intervention as well as non-intervention group.
Change in Attitude of the school going adolescents in the intervention as well as non-intervention group.
Change or cessation of risk behaviour (unhealthy diet, physical inactivity, stress etc) of the school going adolescents in the intervention as well as non-intervention group.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
• Effectiveness of the school-based health promotion intervention modules
• Acceptability of the school-based health promotion intervention modules
|
• Effectiveness of the school-based health promotion intervention modules
• Acceptability of the school-based health promotion intervention modules
|
|
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Target Sample Size
|
Total Sample Size="666" Sample Size from India="666"
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 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Introduction The global burden of non-communicable diseases (NCDs) is a growing public health crisis that requires attention and action from the international community. As the leading cause of mortality, this class of diseases is responsible for 38 million of 57 million annual deaths globally, with 85% of these deaths occurring in low- and middle-income countries (LMICs). However, the discussion on efforts to address NCDs to-date has focused on the adult population, with adolescents largely overlooked who have a substantial share in the global NCD burden [1]. At present, 1.2 billion adolescents aged 10–19 years represent over 18% of the global population. [2] Adolescence is a critical life stage of transition between childhood and adulthood during which adolescents are vulnerable for developing high risk behaviours for NCDs like alcohol or tobacco consumption, unhealthy diet, sedentary lifestyle etc which puts them at high risk of NCDs like cardiovascular diseases, diabetes, cancers, stroke etc [3,4]. The period of transition is dominated by peer pressure or affinity towards social media platforms and poor decision making for what is right or wrong. Timely and appropriate interventions can prevent or cause cessation of these risky behaviours among adolescents and break the vicious cycle of transmitting it to their future generations as well as adulthood. The Covid-19 pandemic further worsened this agonizing situation of the youth of tomorrow. In the Lancet Commission on Adolescent Health Report (2016), it was clearly recommended that investment in dominant NCD-related health behaviours among adolescents is needed to prevent future NCD development in adulthood [5]. Rationale of the Research Addressing NCDs has emerged as a global priority in the Sustainable Development Goals (target 3.4) and the focus includes the establishment and promotion of cost-effective interventions to prevent and address NCDs [6]. However, existing literature provides patchy insight into the current state of NCD-related lifestyle and behavioural risk factors among young people.[1]. Various studies have seen significant implications in behaviour modifications of adolescents if educational interventions are implemented at an early age [7,8]. Hence this study has been planned with the aim to design an educational intervention for prevention of NCDs among school going adolescents attending government schools of Lucknow. This will help in sensitization of the adolescents for prevention of NCDs thereby reducing the burden of disease. Aim: To design and investigate the effectiveness of a School Based Health Promotion Intervention Package to enhance the knowledge, change attitudes and reduce behavioural practices for non-Communicable diseases (NCDs) among the school going adolescents of Lucknow. Primary Objective 1. To conduct a baseline survey to evaluate the knowledge, attitude, and behavioural practices such as unhealthy diet, physical inactivity, stress among the school going adolescents of Lucknow for NCDs (like Diabetes, Hypertension, cardiovascular diseases, breast and cervical cancers and mental disorders). 2. To develop a School Based Health Promotion Intervention Package to enhance the knowledge, change attitudes and reduce behavioural practices for NCDs among the adolescents. 3. To implement the school-based health promotion intervention package on the target population. 4. To assess the effectiveness of the School Based Health Promotion Intervention Package in enhancing knowledge, changing attitudes, and reducing behavioural practices for NCDs among the school going adolescents. Secondary Objectives 1. To evaluate the utility, feasibility, and acceptability of the developed intervention in enhancing the knowledge, changing attitudes, and risk behaviour cessation.
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