| CTRI Number |
CTRI/2025/03/083049 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of diet and exercise on fat levels in obese and overweight children |
|
Scientific Title of Study
|
Effect of dietary modification and exercise on lipid profile of obese and overweight children between 5-14years of age |
| 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 Alok Khanna |
| Designation |
Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak |
| Address |
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9416685096 |
| Fax |
|
| Email |
alokkhanna57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak Haryana |
| Address |
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9050930274 |
| Fax |
|
| Email |
priyanka.alhan1999@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka |
| Designation |
Post Graduate |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak Haryana |
| Address |
Department of Paediatrics Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9050930274 |
| Fax |
|
| Email |
priyanka.alhan1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak |
| Address |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science(PGIMS) Rohtak Haryana-124001 |
| Type of Sponsor |
Government 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 |
| Dr Priyanka |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science |
New OPD Room no 220, PGIMS , ROHTAK
Rohtak
HARYANA |
9050930274
priyanka.alhan1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obese and overweight children
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise and dietary modification |
Effect of lipid profile in same group of obese and overweight children will be observed after 12weeks of intervention.Thirty minutes moderate intensity exercise in form of cycling, jogging etc five days in a week will be advised and standard diet chart as advised by dietician. Compliance will be ensured in routine follow up visit. |
| Comparator Agent |
Obese and overweight children |
Lipid profile in the same group of obese and overweight children will be compared before and after intervention |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Obese and overweight children
Normal weight children |
|
| ExclusionCriteria |
| Details |
Patient with following conditions were excluded:
1. Patients who will not give consent for the study.
2. Presence of any congenital abnormalities. 3. Children with endocrinal cause of obesity. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect on lipid profile |
effect on lipid profile at the time of enrollment and after 90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relation of body weight and dyslipidemia.
Risk factor for dyslipidemia. |
At the time of enrollment |
|
|
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 4 |
|
Date of First Enrollment (India)
|
11/04/2025 |
| 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="1"
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
|
Dietary modification and exercise will be advised to the case group and monthly follow up will be done for 3months.After 3months we again do fasting venous blood sample for lipid profile and check the change in parameter of lipid profile. We will advise 30-40minutes exercise in form of brisk walking at least 5days a week for 12weeks. They will follow diet chart as advised by dietician. Case : 50 obese and 50 overweight children Control : 100 normal weight children |