| CTRI Number |
CTRI/2024/06/069111 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral
Other (Specify) [Institution based intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Carrying out Diabetes Prevention Program for teenagers to improve their behaviour towards healthy lifestyle in urban and rural areas of South Karnataka |
|
Scientific Title of Study
|
Implementation and Evaluation of Program PRAN [Preventing Risk factors among Adolescents for Non-communicable diseases
(Diabetes)] in urban and rural areas of South Karnataka |
| Trial Acronym |
PRAN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejaswini B Darukaradhya |
| Designation |
Assistant Professor |
| Affiliation |
M.S. Ramaiah University of Applied Sciences |
| Address |
M.S. Ramaiah University of Applied Sciences, Faculty of Life and Allied Health Sciences, Department of Public Health, Gnanagangothri Campus New BEL Road, MSR Nagar
Bangalore
KARNATAKA
560054
India |
| Phone |
08045366666 |
| Fax |
|
| Email |
drtejaswini02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tejaswini B Darukaradhya |
| Designation |
Assistant Professor |
| Affiliation |
M.S. Ramaiah University of Applied Sciences |
| Address |
M.S. Ramaiah University of Applied Sciences, Faculty of Life and Allied Health Sciences, Department of Public Health, Gnanagangothri Campus New BEL Road, MSR Nagar
Bangalore
KARNATAKA
560054
India |
| Phone |
08045366666 |
| Fax |
|
| Email |
drtejaswini02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishnamurthy Jayanna |
| Designation |
Adjunct Professor |
| Affiliation |
M.S. Ramaiah University of Applied Sciences |
| Address |
M.S. Ramaiah University of Applied Sciences, Faculty of Life and Allied Health Sciences, Department of Public Health, Gnanagangothri Campus New BEL Road, MSR Nagar
Bangalore
KARNATAKA
560054
India |
| Phone |
08045366666 |
| Fax |
|
| Email |
krishnamurthy.jayanna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research |
|
|
Primary Sponsor
|
| Name |
Faculty of Life and Allied Health Sciences |
| Address |
MS Ramaiah University of Applied Sciences, Gnanagangothri Campus New BEL Road, MSR Nagar, Bangalore - 560054 |
| Type of Sponsor |
Other [Private Instituition] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| D Rajitha |
Bengaluru |
Department: Schools
Division: High school
Room number: 8A, 8B, 9A, 9B
Schools: Brilliance High School, Christ the King School, GHS Bettahalsuru, GHS-Chikkajala, GHS-Jakkur, GHS-Jalahalli, GHS-Kodigehalli, GHS-Yeshwanthpura, New Indian Public School, Ooty Convent, Prameelabhai mane BBMP High School, Sri Jagadguru Panditaradhya School, Vinayaka Vidyanikethan Public School
Bangalore
KARNATAKA |
7095972247
rajithayadav108@gmail.com |
| Sampreetha D V |
Chikkaballapur |
Department: Schools
Division: High school
Room number: 8A, 8B, 9A, 9B
Chikkaballapura Schools:
Adarsha Vidyalaya Devaragudipalli, Shantiniketan High School-Bagepalli, Sri Sathya Sai Nagar Bagepalli, GHS Gulur-Bagepalli
Kolar
KARNATAKA |
8431882464
samprethaprethu@gmail.com |
| Sony Sequeira |
Tumkur |
Department: Schools
Division: High school
Room number: 8A, 8B, 9A, 9B
Tumkur Schools: Government Junior School,
Ravindra Bharathi English High School,
Kalidasa govt High school,
Veerbhadraswamy rural high school, Don Bosco high school
Tumkur
KARNATAKA |
9591025615
sonysequeira23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MSRUAS University Ethics Committee for Human Trials |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Display of Educational Poster on diabetes and its risk factors |
After the pre-asessment of Knowledge, attitude and Practice of the adolescents in the educational institution, Poster on diabetes and its risk factors will be displayed in the institution of comparator group sites |
| Intervention |
Intervention will have educational capsules and activity capsules on Diabetes and its risk factors |
Qualitative study will be carried out in all the selected
intervention sites to assess the needs of the school community and
adolescents to develop specific intervention content and activities. Development of intervention: It is based on the context of intervention setting
and target group. It will involve the following steps:
i. Development of a conceptual behavioural intervention model
ii. Ensuring the appropriateness of the model
iii. Development of intervention strategies to modify risk factors
iv. Implementation and assessment
Intervention activities
will follow guidelines from WHO and other standard governmental guidelines
(NPCDCS guidelines) and from evidence-based practices in developing
each of the activitys capsules. Intervention will be based on a suitable
theory which has components of observation learning, modeling, goal
setting, self-regulation, self-management and self-efficacy. It is often referred
to as a bridge behaviorist and cognitive learning theories because it
encompasses attention, memory, and motivation with added social element
component, arguing that people can learn new information and behaviors by
watching other people which is known as observational learning (or
modeling). It also integrates many discrete ideas, concepts, and subprocesses into an overall framework for understanding human functioning
Proposed intervention sessions: The multi-modal intervention includes
the following components:
1. Classroom based educational capsules: NCD, diabetes and its risk
factors, healthy behaviour and lifestyle (short educational capsules of 8-10
minute will be delivered once a week in the first month, followed by monthly
refreshers sessions through the intervention period).
2. Classroom based activities capsules: Activities of theory
components, games and demonstrations to improve efficacy and selfmanagement, to overcome day today challenges and temptations. This will
include case studies and role plays of real life situations, appreciating and
celebrating champions, formation of peer groups, as well as effective
neurobehavioral interventions such as yoga and meditation (60 minute
activity every day in the first week followed by 30 minute activity every day
for the entire intervention period)
3. Home based activities capsules: Activities and practices inclusive of
parental engagement (30-minute activity session engaging parent once a
week) |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate |
|
| ExclusionCriteria |
| Details |
Not willing to participate |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Change in knowledge, attitude and practice of adolescents in pre and post intervention focusing NCD Risk factors.
2) Reduction in prevalence of risk factors as compared to the control group.
|
Baseline, 6 months and 12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Body mass Index of adolescents in the project site |
Height and Weight measurements pre and post intervention. |
|
|
Target Sample Size
|
Total Sample Size="2256"
Sample Size from India="2256"
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)
|
25/06/2024 |
| 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="2"
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
|
We intent to implement and evaluate Program PRAN [Preventing Risk factors among adolescents for non-communicable diseases (Diabetes)] in urban and rural areas of South Karnataka, targeting adolescents to address diabetes risk factors. It involves a mixed-methods approach, including qualitative research to assess needs, quantitative study with measuring effectiveness of the intervention through a pre and post intervention evaluation, and cost effectiveness. |