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CTRI Number  CTRI/2019/09/021234 [Registered on: 13/09/2019] Trial Registered Prospectively
Last Modified On: 12/09/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Cluster Randomized Trial 
Public Title of Study   The study is to identify the knowledge, attitude and health risk behavior among the adolescents.The multipronged approach will be implemented to reduce the health risk behavior among adolescents.  
Scientific Title of Study   Effectiveness of multipronged approach on knowledge, attitude and health risk behavior among adolescents of pre university colleges of Udupi district. 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manjula 
Designation  Asst. Professor 
Affiliation  Manipal College of Nursing,MAHE,Manipal 
Address  Department of Community Health Nursing Manipal College of Nursing Madhav Nagar, MAHE, Manipal 576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9535269957  
Fax  91-0820-2922572  
Email  manju.uppi@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Baby S Nayak 
Designation  Professor & HOD 
Affiliation  Manipal College of Nursing,MAHE,Manipal 
Address  Department of CHILD Health Nursing Manipal College of Nursing Madhav Nagar, MAHE, Manipal 576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9448174791  
Fax  91-0820-2922572  
Email  baby.s@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Manjula 
Designation  Asst. Professor 
Affiliation  Manipal College of Nursing,MAHE,Manipal 
Address  Department of Community Health Nursing Manipal College of Nursing Madhav Nagar, MAHE, Manipal 576104 Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9535269957  
Fax  91-0820-2922572  
Email  manju.uppi@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing, MAHE,Manipal 
 
Primary Sponsor  
Name  Manjula 
Address  Asst.Professor, Dept. of Community Health Nursing Manipal College of Nursing Madhav Nagar, MAHE, Manipal Karnataka, India PIN:576104  
Type of Sponsor  Other [Self] 
 
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 
Manjula  Pre University Colleges  Office of the Deputy Director for Public Instruction Rajathadri. C Block, II Floor, Udupi-57610
Udupi
KARNATAKA 
9535269957

manju.uppi@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Kospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Health risk behavior among adolescents 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multipronged Approach  Multi pronged approach includes awareness program on youth risk behavior & its impact, awareness program for the teachers.facilitation for the health seeking behavior, assistance and guidance for the counseling services for the needy adolescents. Duration of the intervention is for 2 hours each time at one month,3rd and 6th month 
Comparator Agent  The comparator group is without the multipronged approach.  The comparator group will be provided with multi pronged approach after investigating the effectiveness of intervention in the experimental group. The duration of the intervention is for 2hours each time. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Sampling criteria for the Phase I:
Pre university colleges with more than or equal to 60 students from both urban and rural areas.
Adolescent between the age group of 16-18 years, studying in first year PUC.
The students studying in all the streams.
Those who are willing to take part in the study.
Available during the time of data collection
Sampling criteria for the Phase II:
Colleges identified with adolescents having higher percentage (minimum10% prevalence of health risk behavior) of health risk behavior

 
 
ExclusionCriteria 
Details  Adolescents who have problem with the communication and cognition.
Adolescents with congenital disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Health risk behavior, knowledge on health risk behavior, attitude on health risk behavior.  At 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Health risk behavior, knowledge on health risk behavior, attitude on health risk behavior.  At 1,3 and 6 months 
 
Target Sample Size   Total Sample Size="900"
Sample Size from India="900" 
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)   30/10/2019 
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="4"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The objectives of the study are to assess the health risk behavior among adolescents,explore the factors influencing health risk behavior among adolescents, find the effectiveness of multipronged approach on knowledge, attitude on  youth risk behavior, & health risk behavior of adolescents.

The purpose of the study is to identify the knowledge, attitude and health risk behavior among the adolescents. This will help the investigator to identify the need/ problems with regard to health risk behavior among adolescents in the early stage. Hence the findings will be utilized to assist the adolescents to overcome the risk behavior, which has a greater impact on their health and future life. The multipronged approach will be implemented in the colleges identified with higher percentage (minimum10% prevalence) of health risk behavior among adolescents. The outcome of the multipronged approach will be evaluated on improving the knowledge of youth risk behavior, improved score on attitude towards youth risk behavior and improved practices related to health risk behavior which in turn will contribute to have healthy and productive adolescents.

The hypothesis of the study are,

H 1: There will be a significant difference in the mean pretest and posttest knowledge scores of adolescents in the intervention group.
H2:  There will be a significant difference between the mean posttest knowledge scores of adolescents in the intervention &control group.
H3: There will be a significant difference in the mean pretest and posttest attitude scores of adolescents in the intervention group.
H4:  There will be a significant difference between the mean posttest attitude scores of adolescents in the intervention &control group.
H5: There will be a significant difference in the pretest and posttest health risk behavior of adolescents in the intervention group.
H6:  There will be a significant difference in the health risk behavior of adolescents between intervention &control group.

 

Multistage cluster sampling technique will be used for the Phase I of the study. Among six thaluks under Udupi districts 16 colleges will be selected by lottery method. For the phase I, after obtaining the administrative permission, the content of the informed consent form and participant information sheet will be explained to the students. The subject information sheet, informed consent and the assent will be sent home with the students to get the permission from the parents for the participation in the study.The next day the students will be asked to bring the signed assent and informed consent form.  The following research tools will be administered in the college as per the convenience of the school authority; Tool1: Demographic Proforma, Tool2: Youth Risk Behaviour assessment questionnaire. After the data collection the study participants will be encouraged to express their issues in detail in Tool 3(Semi structured tool to explore the factors) and put it in the anonymous students friendly box on the next day which will be kept in the college by the investigator. In the Phase II, based on factors explored and youth risk behaviour, multipronged intervention package will be modified if required and validated. Based on the sample size calculation and the inclusion criteria out of sixteen colleges, six colleges will be allocated into experimental and control group. For both the groups the pre-test will be carried out by administering the Tool4: Structured knowledge questionnaire on Youth Risk Behaviour and Tool 5: Rating scale to assess the attitude on health risk behaviour to assess the knowledge and attitude on youth risk behaviour among the adolescents. For the phase II, cluster (colleges) of adolescents meeting the inclusion criteria will be allocated into experimental and control group. Multipronged approach refers to intervention program which includes awareness program on youth risk behavior & its impact, awareness program for the teachers,facilitation for the health seeking behavior, assistance and guidance for the counselling services for the needy adolescents.The effectiveness of the multipronged  approach will be assessed in terms of improvement in post-test mean scores on knowledge and attitude and improvement in health risk behaviour. The analysis of the data will be done based on the objectives of the study. Data will be analysed using SPSS Software. Descriptive statistics such as frequency and percentage, inferential statistics such as Pearson correlations and multivariate analysis will be used. The demographic variables and youth risk behaviour  in frequency and percentage, knowledge and attitude in mean, standard deviation and frequency percentage, Effectiveness in terms of mean, standard deviation, paired and independent t test and Repeated measure ANOVA. 



 
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