| CTRI Number |
CTRI/2025/06/088852 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Randomized control Trial of nurse led family-based intervention on childhood obesity among children. |
|
Scientific Title of Study
|
Cluster Randomized Trial of Nurse-led Familybased Intervention on childhood obesity among Children at selected schools of Vadodara. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpan Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing, CHARUSAT |
| Address |
Room No.310, Community Health Nursing Laboratory, Manikaka Topawala
Institute of Nursing, CHARUSAT Campus, Off. Nadiad-Petlad Highway, Changa-
388421, Gujarat
Anand
GUJARAT
Manikaka Topawala Institute of Nursing Charotar University of Science and Technology CHARUSAT campus Changa off Nadiad Petlad Highway At&Po Changa Taluka Petlad District Anand
Anand
GUJARAT
388421
India |
| Phone |
9638755369 |
| Fax |
|
| Email |
arpanpandya.nur@charusat.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Arpan Pandya |
| Designation |
Assistant Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing, CHARUSAT |
| Address |
Room No.310, Community Health Nursing Laboratory, Manikaka Topawala
Institute of Nursing, CHARUSAT Campus, Off. Nadiad-Petlad Highway, Changa-
388421, Gujarat
Anand
GUJARAT
ManikakaTopawalaInstitute of Nursing CharotarUniversity ofScience and Technology CHARUSATcampus Changa off Nadiad Petlad Highway At&Po Changa Taluka Petlad District Anand
Anand
GUJARAT
388421
India |
| Phone |
9638755369 |
| Fax |
|
| Email |
arpanpandya.nur@charusat.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anil Sharma |
| Designation |
Principal cum Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing, CHARUSAT |
| Address |
Room 101, Principal Office, Manikaka Topawala Institute of Nursing, CHARUSAT
Campus, Off. Nadiad-Petlad Highway, Changa-388421, Gujarat.
Anand
GUJARAT
388421
India
Anand
GUJARAT
388421
India |
| Phone |
8140364743 |
| Fax |
|
| Email |
anilsharma.nur@charusat.ac.in |
|
|
Source of Monetary or Material Support
|
| Asoj Primery School,Ta.&Dist. Vadodara |
| Shree Vinay Vidyalay,Asoj Ta.&Dist. Vadodara |
| Urmi School, Sama-Savli Rd, near Flyover, Kumbhar Wada, Raghuvir Nagar, Anandvan Society, New Sama, Vadodara, Gujarat 390024 |
|
|
Primary Sponsor
|
| Name |
NIl |
| Address |
Nill |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kirti J Pandya |
Asoj Primery School |
Asoj Primery School District Vadodara
Vadodara
GUJARAT |
9427573612
Kirtipandya74@gmail.com |
| Jignesh Kumar B Patel |
Shree Vinay Vidyalay |
Shree Vinay Vidyalay, Asoj Taluka and District Vadodara
Vadodara
GUJARAT |
9913779255
PatelJb25380@gmail.com |
| Dr Mukesh Udasi |
Urmi School |
Urmi School Sama Savli Road New Sama Vadodara
Vadodara
GUJARAT |
9898920911
urmischool@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CHARUSAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Childhood Obesity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse Led family based intervention |
It is a set of intervention consist of
A) Motivational interviewing
B) Exerplay activity
C) Nutritional mentoring includes Diet and Water fasting to monitor changes in BMI status. The total Duration of intervention will be 3 months. |
| Comparator Agent |
Routine life style. |
Routine day today activity by participant without researchers instructions.Total Duration will be 3 months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1
1. Children studying at schools of Vadodara District.
2. Children aged between 12-16 years of age.
3. Children and parents providing ascent and consent to participate in study.
4. Children studying in schools providing permission to conduct research study.
Phase 2
1. Children found obese under category (BMI above 30)
2. Over weight (BMI 85th percentile to less than 95th percentile)
3. Obesity (BMI 95th percentile or grater)
4. Savior Obesity Class I: BMI 120th of 95th percentile or grater
|
|
| ExclusionCriteria |
| Details |
1Children undergoing treatment of obesity.
2Children who are not willing to participate in study.
3Children with known metabolic or any other risk conditions.
4Child falling into saviour obesity class II and III will be excluded into study.
5Medical conditions known to promote obesity.
6Already involved with another weight control program
7Child with developmental disability
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant change in BMI status |
At recruitment, at 45 days and at 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
Target Sample Size
Modification(s)
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
21/08/2025 |
| 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="0"
Months="3"
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
Modification(s)
|
Title: Cluster Randomized controlled trial of Nurse Led family based intervention on childhood obesity among children at selected schools of Vadodara. Objectives: a) To assess the impact of nurse-led family-based intervention on BMI status among controlled and experimental group. b) To determine the association between selected demographic variable with BMI status among children. c) To determine change in attitude and level of awareness of study samples regarding his/her health status. d) To monitor change in BMI status among controlled and experimental group over the period of study. (at beginning, at 45 days and at 90 days) Hypothesis: H01: There will be no significant difference in BMI status among study samples before and after administration of Nurse led family based intervention on childhood obesity among control and experimental group at 0.05 level of significance.
|