| CTRI Number |
CTRI/2024/12/078348 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical Activity Habits and Beliefs in Children with Juvenile Diabetes: A Survey Study |
|
Scientific Title of Study
|
Knowledge, Attitude, and Practice of Physical Activity among Children with Juvenile Diabetes: A Cross-Sectional Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor |
| Address |
Advance Physiotherapy center Department of pediatrics physiotherapy room no 39 Sagar floor KLE DR Prabhakar Kore Hospital & MRC , Belagavi- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Sankapal |
| Designation |
Postgraduate student |
| Affiliation |
Postgraduate student |
| Address |
Advance Physiotherapy center Department of pediatrics physiotherapy room no 39 Sagar floor KLE DR Prabhakar Kore Hospital & MRC , Belagavi, Karnataka, India- 590010
KLE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belagavi, Karnataka, India- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
6366038601 |
| Fax |
|
| Email |
nachiketsankapal082001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Associate Professor |
| Affiliation |
Associate Professor at KLE Instituteof Physiotherpay |
| Address |
Advance Physiotherapy center Department of pediatrics physiotherapy room no 39 Sagar floor KLE DR Prabhakar Kore Hospital & MRC , Belagavi- 590010
Staff room, 2nd floor, KLE institute of Physiotherapy, JNMC campus, Belagavi, Karnataka, India- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy Belagavi, Karnataka, India-590010 |
|
|
Primary Sponsor
|
| Name |
KLE Institute of Physiotherapy |
| Address |
KLE Institute of Physiotherapy, nehru nagar belagavi- 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinuta Deshpande |
KAHER Institute of Physiotherapy |
Advance Physiotherapy center Department of pediatrics physiotherapy room no 39 Sagar floor KLE DR Prabhakar Kore Hospital & MRC , Belagavi- 590010
Belgaum
KARNATAKA |
8754466612
vinuta.gangavatikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
both genders between 4 and 18 years
children diagnosed with type 1 diabetes mellitus
parents willing to participate in the study |
|
| ExclusionCriteria |
| Details |
children who are not able to perform the physical activity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Knowledge of physical activity questionnaire
Attitude of Physical Activity questionnaire.
International Physical Activity questionnaire |
Baseline- T0 at the time of pre assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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)
|
30/12/2024 |
| 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="0"
Months="6"
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
|
The research study titled "Knowledge, Attitude, and Practice of
Physical Activity among Children with Juvenile Diabetes: A Cross-Sectional
Study" aims to assess the awareness, attitudes, and practices regarding
physical activity (PA) in children with Type 1 diabetes (T1D) in Belagavi,
Karnataka. T1D is an autoimmune disease leading to insulin deficiency, and
while physical activity is beneficial for managing blood sugar and preventing
complications, its practice among children with T1D remains low.
The study seeks to identify gaps in knowledge and adherence to PA
recommendations, recognizing that higher knowledge, positive attitudes, and
regular practice of PA are linked to better health outcomes. The research uses
structured questionnaires and the WHO Global Physical Activity Questionnaire to
gather data from 73 children aged 4 to 18 diagnosed with juvenile diabetes. It
will focus on the correlation between physical activity and the management of
diabetes complications, emphasizing the role of health education.
The findings aim to inform interventions that
enhance awareness and encourage PA, which can improve diabetes management and
prevent long-term health issues. This observational, cross-sectional study is
expected to contribute valuable insights into the effective promotion of
physical activity among children with juvenile diabetes |