| CTRI Number |
CTRI/2024/08/072180 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Choice dependent programme] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the effect of choice dependent programme compared to routine physical exercise on health and school performance of primary school children |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of choice dependent programme verses routine physical exercise on physical and mental health along with academic performance of primary school children: RCT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhuri Shambharkar |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing
Smt. Radhikabai Meghe Memorial College Of Nursing, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403339535 |
| Fax |
|
| Email |
mnnaik91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing
Smt. Radhikabai Meghe Memorial College Of Nursing, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
Associate Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Nursing
Smt. Radhikabai Meghe Memorial College Of Nursing, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Madhuri Shambharkar |
Datta Meghe Institute of Higher Education and Research |
Department of Community Health Nursing
Smt. RadhikabaiMeghe Memorial College Of Nursing, Sawangi Meghe 442001
Wardha
MAHARASHTRA |
9403339535
mnnaik91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary school children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Choice dependent programme |
School children will be provided with training on different games and exercises. They will practice it for 1 hour daily for 6 months. |
| Comparator Agent |
NIL |
Children with routine school activities |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary school children between 6 to 12 years of age |
|
| ExclusionCriteria |
| Details |
1. Primary school children with chronic disease.
2. Primary school children those are physically disabled.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
200 children will be assessed for changes in physical health, mental health and academic performance.
|
Assessment will be done at 1, 3 and 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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 Yet Recruiting |
| 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
|
This will be a comparative efficacy of choice dependent programme verses routine physical exercise on physical and mental health along with academic performance of primary school children. 200 children from different schools in Wardha district will be enrolled and provided with training on different exercises. Children will practice choice based exercises and the changes in physical, mental health parameters and academic performance will be assessed at 1, 3 and 6 months from the date of enrollment. The data will be analyzed using appropriate statistical tests. |