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CTRI Number  CTRI/2025/08/092852 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Educational Trial focused to change behaviours in school children]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Impact of health program to improve healthy habits and well-being among High school children in Goa 
Scientific Title of Study   Effectiveness of a School-based Health Promotion Program (SHPP) on Lifestyle Behaviours, Life skills, and Well-being among high school children in Goa- A Cluster Randomized Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Conceicao Vaz 
Designation  Nursing Tutor (Part-time Ph.D. Scholar) 
Affiliation  Institute of Nursing Education, Bambolim Goa 
Address  Room no. 4, Cabin no. 4, First Floor, Institute of Nursing Education, Bambolim Goa

North Goa
GOA
403202
India 
Phone  8805702027  
Fax    
Email  conceicao.mconmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Binil V. 
Designation  Additional Professor & Head of Department (HoD) 
Affiliation  Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 
Address  HoD Room, Sixth Floor, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9844387432  
Fax    
Email  vp.binil@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr. Ridhima Gaunkar 
Designation  Professor 
Affiliation  Goa Dental College and Hospital, Bambolim Goa 
Address  Department of Public Health Dentistry- No. 8, Goa Dental College and Hospital, Bambolim Goa

North Goa
GOA
403202
India 
Phone  9326469134  
Fax    
Email  drbirmani@gmail.com  
 
Source of Monetary or Material Support  
Institute of Nursing Education, Bambolim Goa. Part time Ph.D. Scholar at Manipal College of Nursing, Manipal Academy of Higher Education (MAHE), Manipal, Udupi 
 
Primary Sponsor  
Name  Institute of Nursing Education 
Address  Institute of Nursing Education, Bambolim Goa Pincode: 403202 
Type of Sponsor  Other [Government Nursing College] 
 
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 
Conceicao Vaz Principal Investigator MSc Nursing Ph D Scholar  Institute of Nursing Education  Room no. 04, Cabin No. 4,First Floor, Institute of Nursing Education, Bambolim Goa, 403202 The recruitment of the participants, implementation of intervention and data collection will be done in Goa initiating from Institute of Nursing Education, Bambolim Goa. No data collection will be done in Manipal or around the places in Manipal. EC obtained from KMC-KH as I am Part-time Scholar of MAHE
North Goa
GOA 		 8805702027

conceicao.mconmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Directorate of Health Services, Panaji Goa  Approved 
Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Providing knowledge to participants on lifestyle behaviours, teaching life skills and to assess mental wellbeing  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine Academic Activities  The control group will receive the routine academic activities offered by the school. However, the control group will be given the educational intervention received by the experimental group after the final data collection 
Intervention  School-based Health Promotion Program (SHPP)  The School-based Health Promotion Program (SHPP) is an educational intervention designed in this study that will consist of providing an understanding to the school children about common lifestyle behaviours (Dietary patterns, Screen time, Physical activity, Smoking, Alcohol, Oral Health, Sexual Health, Sleep habits) and provide them with knowledge about the impact of these lifestyle behaviours on health. This intervention will include various teaching activities such as story telling, role plays, games, videos, group activities, demonstration and re-demonstration of skills for providing knowledge and development of life skills that will help promote healthy behaviours and improve mental well-being of school children. The total intervention will be conducted in 12 sessions. One session every alternate day so that students take time to understand the concepts and information that is given. Intervention development will be based on Medical Research Council (MRC) framework. This Framework has four steps; that is: Developing the Intervention, Assessing Feasibility, Pilot implementation and Evaluation. Also, the framework has core elements which include: Assessing effectiveness of various interventions through extensive literature search to adapt with the chosen module (Life Skills Module); Developing, refining based on the programme theory that will help lead the intervention (SHPP); Engaging stakeholders (Teachers, Parents, Students and Health Care Professionals) to cover up important areas related to the school children; Identifying key factors of what is known already and what requires to be known about the SHPP; Refining the intervention as per the programme theory, feasibility and acceptability; Economic considerations will be managed 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Students studying in English medium from Govt and Govt Aided schools.

Students studying in Std VIII will be selected to participate in the study.

Students present on the day of data collection and sampling will be considered in the study.

Students willing to participate through parents’ consent will be considered in the study.

 
 
ExclusionCriteria 
Details  Students diagnosed with psychological disturbances and learning disabilities

Students who are not willing to participate 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in lifestyle behaviours, life skills and well-being  Pretest, seventh day of post intervention and two follow-ups (third month and Sixth month) 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in knowledge of lifestyle behaviours and in well-being through application of life skills learnt  Seventh day of post intervention, third month and sixth month 
 
Target Sample Size   Total Sample Size="206"
Sample Size from India="206" 
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   N/A 
Date of First Enrollment (India)   10/09/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This study will use the quantitative research approach and cluster randomized controlled trial design. The objectives of the study are to develop and validate the School-based Health Promotion Program (SHPP) for high school children and to determine the effectiveness of School-based Health Promotion Program (SHPP) on lifestyle behaviors, life skills, and well-being among high school children. The participants will include students studying in high schools in Goa and will be selected through cluster randomization. A Focus Group Discussion (FGD) with different stakeholders will be done to develop the intervention-School-based Health Promotion Program (SHPP). The data collection tools will include- Lifestyle Behaviours Scale, Life Skills Assessment Scale (LSAS), and Sterling’s Children Well-being Scale. Ethical Clearance is obtained from the Directorate of Health Services, Panaji Goa. Necessary permissions will be taken from the concerned authorities. Consent will be taken from the parents of the students and assent will be taken from the participants. A Pilot study will be conducted and analyzed, and necessary modifications will be made. The experimental group will receive the intervention and the control group will be shown a short film after the completion of follow-ups with the experimental group. Data from the participants will be collected before the intervention, on the seventh day of post intervention and two follow-ups (third month and sixth month). 
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