| CTRI Number |
CTRI/2025/10/095890 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on Physical and Mental Health Among Children with Diabetes |
|
Scientific Title of Study
|
Effect of Yoga on Psychological Wellbeing and Cell Survival Biomarkers Among Children and Adolescents with Type 1 Diabetes: An Open Label Randomized Control Trial |
| Trial Acronym |
YOUTH-T1D: Yoga for Optimal Uplift in Thoughts and Health in T1D |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Deptt of Pediatrics, PGIMER, Sector 12,Chandigarh
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008480 |
| Fax |
|
| Email |
drrakesh.pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indu Rani |
| Designation |
PhD Student |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Deaprtment of Pediatrics, PGIMER Chandigarh
PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8105175790 |
| Fax |
|
| Email |
indum0907@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Deptt of Pediatrics, PGIMER, Sector 12,Chandigarh
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008480 |
| Fax |
|
| Email |
drrakesh.pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR), New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research (ICMR), New Delhi |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Rakesh Kumar |
PGIMER, Chandigarh |
Room No 3117, Level 3A,Deptt of Pediatrics, APC Building
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
7087008480
drrakesh.pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Intervention (Standard Care) |
Group B (Control group): Children and adolescents with T1D will be provided only the standard T1D care for 6 months and will be considered as
waitlisted control groups.
Group D (Control group): Caregivers of Group B will not be provided any Yoga intervention for 6
months and will be considered as waitlisted control groups. |
| Intervention |
Yoga |
The participants (Children and adolescents along with their respective one primary caregivers) will be trained for a 30-minute, specific Yoga protocol for T1D. The Yoga will be performed for 5 days/week for 6 months via
online mode by a trained and certified Yoga trainer.
Group A (Intervention group): Children and adolescents with T1D will be provided Yoga intervention along with the standard T1D care for 6 months (5 days Yoga
session/week).
Group C (Intervention group): Caregivers of Group A will be provided Yoga intervention
along with their child for 6 months (5 days Yoga session/week) |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for children and adolescents with T1D:
1. T1D diagnosed for at least 1 year.
2. Age- 8 to 18 years
(inclusive ± 6 months)
3. Both genders.
4. Informed consent provided by the parent or the legal guardian, and assent by the children
Inclusion criteria for caregivers of children and adolescents with T1D:
1. Age of caregiver 25- 45 years
2. The caregiver should be actively
involved in the care of the child for at least 6 months and should be able to continue till the end of the intervention.
3. Accessibility of a smartphone to attend an online Yoga class
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for children and adolescents with T1D:
1. Previously diagnosed intellectual disability, psychiatric disorders
2. Participants with chronic systemic illness, such as celiac disease, kidney, liver, or cardiovascular disease
3. Individuals having physical limitations which restrain them from performing Yoga
4. Already practising Yoga regularly
5. Individuals participating in any other trial
6. More than 1 child with T1D in the family
Exclusion criteria for caregivers of children and adolescents with T1D:
1. Caregivers managing more than one child with T1D in the family
2. Pregnant mothers
3. Caregivers with any psychiatric illness
4. Individuals who regularly practice Yoga
5. Caregivers taking long-term treatment for any major chronic illness
6. An individual with physical disabilities which restrain them from practising Yoga Intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Yoga on psychological parameters i.e Depression, Diabetes Distress, Quality of life and Behavioral problems in children with Type 1 diabetes. |
3 months interval for 1 year (Baseline, 3rd month, 6th month, 9th month, 12th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of Yoga on cell survival biomarkers, and HbA1c, mean FBG and mean blood glucose in children and adolescents with T1D.
|
3 months interval for 1 year (Baseline, 3rd month, 6th month, 9th month, 12th month) |
Effect of Yoga on psychological well-being (Distress, Quality of life and burden) of caregivers.
|
3 months interval for 1 year (Baseline, 3rd month, 6th month, 9th month, 12th month) |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="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
|
The global prevalence of Type 1 diabetes (T1D) in children and adolescents has been rising, with India reporting the highest numbers, as per the International Diabetes Federation (IDF). T1D contributes to chronic microvascular and macrovascular complications, in addition to psychological challenges, diminishing the quality of life for patients and their caregivers. Yoga, a holistic and inexpensive practice, could be an adjunct therapy to address these complications. There are very few studies on the benefits of Yoga for adolescents and children with T1D. There is no standardized T1D-specific Yoga module, insufficient long-term research, and limited focus on T1D population as compared to documented beneficial effects of Yoga among individuals with T2D. This is the first study to explore the effects of Yoga on psychological well-being and cellular health biomarkers among children and adolescents with T1D, along with their caregivers. The study aims to assess the impact of Yoga on psychological health, quality of life, and cellular biomarkers, and glycemic control in children and adolescents with T1D. An open-label, randomized controlled trial, with Yoga as intervention, will be conducted involving children and adolescents with T1D and their caregivers. Primary outcomes will include psychological health, while secondary measures encompass children’s cellular biomarkers, quality of life, HbA1c, and caregivers’ psychological well-being. A standardized, T1D-specific Yoga module, as a low-cost, accessible therapy, is expected to enhance psychological and biomolecular health, improve quality of life, foster glycemic control, and strengthen the parent-child bond, ultimately mitigating long-term complications of T1D. |