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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 
 
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  
 
Source of Monetary or Material Support  
ICMR, New Delhi 
 
Primary Sponsor  
Name  ICMR New Delhi 
Address  ICMR, New Delhi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONALETHICALCOMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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.  
 
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 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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.

 
 
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
 
 
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
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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