| 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 |
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Secondary IDs if Any
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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 |
|
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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] |
|
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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 |
| 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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Kospital 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 |
Health risk behavior among adolescents |
|
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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. |
|
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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
|
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| ExclusionCriteria |
| Details |
Adolescents who have problem with the communication and cognition.
Adolescents with congenital disorders
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Health risk behavior, knowledge on health risk behavior, attitude on health risk behavior. |
At 6 months |
|
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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 |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |