| CTRI Number |
CTRI/2021/11/037744 [Registered on: 02/11/2021] Trial Registered Prospectively |
| Last Modified On: |
31/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of structure teaching Programme and yoga on biophysiological parameters, stress and anxiety among overweight and obese children |
|
Scientific Title of Study
|
Evaluate the Effectiveness Of Nurse Led Health Promotion Practices On Biophysiological Parameters, Stress And Anxiety Among School Going Overweight And Obese Adolescents (11- 13 Years) At Schools Of Puducherry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MrsSarithaG |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, Pondicherry Institute of Medical Sciences. |
| Address |
College of Nursing
Department of child health nursing 2nd floor Room No 04
Pondicherry Institute of Medical Sciences
Ganapathychettikulam
Kalapet
Puducherry
College of Nursing
Department of child health nursing 2nd floor Room No 04
Pondicherry Institute of Medical Sciences
Ganapathychettikulam
Kalapet
Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9786740206 |
| Fax |
|
| Email |
gsaritha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MrsSarithaG |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, Pondicherry Institute of Medical Sciences. |
| Address |
College of Nursing
Department of child health nursing 2nd floor Room No 04
Pondicherry Institute of Medical Sciences
Ganapathychettikulam
Kalapet
Puducherry
College of Nursing
Department of child health nursing 2nd floor Room No 04
Pondicherry Institute of Medical Sciences
Ganapathychettikulam
Kalapet
Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9786740206 |
| Fax |
|
| Email |
gsaritha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MrsSarithaG |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, Pondicherry Institute of Medical Sciences. |
| Address |
College of Nursing
Department of child health nursing 2nd floor Room No 04
Pondicherry Institute of Medical Sciences
Ganapathychettikulam
Kalapet
Puducherry
College of Nursing
Department of child health nursing 2nd floor Room No 04
Pondicherry Institute of Medical Sciences
Ganapathychettikulam
Kalapet
Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9786740206 |
| Fax |
|
| Email |
gsaritha@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing Pondicherry Institute of Medical Sciences Puducherry 14 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education Research |
| Address |
Sri Ramachandra Institute of Higher Education & Research DU Chennai 600116 |
| 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 |
| Saritha G |
Pondicherry Institute of medical sciences Hospital , Puducherry |
College of Nursing
Department of child health nursing 2nd floor Room No 04
Pondicherry Institute of Medical Sciences
Ganapathychettikulam
Kalapet
Puducherry
Pondicherry
PONDICHERRY |
9786740206
gsaritha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pondicherry Institute of Medical Sciencesi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
OVERWEIGHT AND Obese adolescent |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
for control group their regular activity |
| Intervention |
yoga practice |
for rxperimental group yoga practice for 40 minutes per session, 3 times a week for the 24 weeks at selected urban Private School of Puducherry.
for control group their regular activity |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Overweight and Obese adolescent age between 11 yrs to 13 yrs at selected urban private schools of Puducherry
Who is willing to participant in the study
who is regular for school
|
|
| ExclusionCriteria |
| Details |
Overweight & Obese adolescent children,
With chronic medical problems
Who had any surgery in the past six months
Who is on regular yoga practice already
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight and BMI |
at 3 months and 6 months after yoga practice |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Waist Circumference, Hip circumference. Skin folds Thickness and Blood Pressure. FFM, fat percentage, total fat mass, cellular hydration status (total body water, Extra Cellular Fluid, Intracellular fluid), basal body metabolism. Blood sugar, blood lipids, Apolipoprotein AI, Apolipoprotein B, Adiponectin, leptin Adolescent stress score and anxiety score |
at 3 months and 6 months after yoga practice |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2 |
|
Date of First Enrollment (India)
|
03/01/2022 |
| 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="1"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized control trial parallel group active control trial to assess the effectiveness of structure teaching program and yoga on biophysiological parameters stress and anxiety among overweight and obese adolescents 11 to 13 at selected schools of puducherry. The primary outcome of knowledge on overweight and obesity ,weight and BMI will be measured at 3 months and 6 months after yoga practice. The secondary outcome will be waist circumference , hip circumference ,body composition , fasting blood sugar , lipid profile , apolipoprotein A, apolipoprotein B , adiponectin, leptin , anxiety and stress score .this will be measured at 3 months and 6 months after yoga practice
|