| CTRI Number |
CTRI/2024/11/076514 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nursing Interventions] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effectiveness of Multidimensional Nursing Interventional Package |
|
Scientific Title of Study
|
Effectiveness of Multidimensional Nursing Interventional Package on nutritional status among malnourished children in selected Tribal area |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahantesh Dasyal |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Dept of Nursing, HOD Block, Bhonsala Institute of Nursing Rambhoomi
Nashik
MAHARASHTRA
422005
India |
| Phone |
|
| Fax |
|
| Email |
mahantesh9009@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr S P Subashini |
| Designation |
Dean Nursing |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Department of Medical Srgical Nursing, Room No 101, Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6399000660 |
| Fax |
|
| Email |
dean.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mahantesh Dasyal |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Department of Pediatric Nursing, Room No 5, Bhonsala Institute of Nursing, Nashik
Nashik
MAHARASHTRA
422005
India |
| Phone |
7696504073 |
| Fax |
|
| Email |
mahantesh9009@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Nursing, Teerthanker Mahaveer University Delhi road Moradabad 244001 |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer University |
| Address |
Delhi Road, NH9, Moradabad, Uttar Pradesh 244001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Mahantesh D |
Jategaon Village |
Department of Child Health Nursing, Room No. 01 Trmbakeshwar road Nashik
Nashik
MAHARASHTRA |
7696504073
mahantesh9009@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sarpanch Gram Panchayat Jategaon |
Approved |
| Teerthanker Mahaveer University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Malnourished children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Millet Mix |
Millet mix powder offer the good amount of calories, Protein, dietary fiber, Calcium, Magnesium and other micronutrient these qualities contribute to overall health of child including weight gaining, digestive, bowel regularity and suitable for all age of children. |
| Intervention |
Nutritionl suppliments for children, Teaching program, Menu plan, Providing Albendazole tablet to prevent worm infection |
Millet mix given for 3 months, Educating to parents and children, and Albendazole tablet to prevent worm infection |
| Intervention |
Teaching program, Menu plan |
Educating to parents and children |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Malnourished children.
Age group between 2 - 5 years |
|
| ExclusionCriteria |
| Details |
Children who are suffering from chronic illness |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increases in mean difference of weight |
Increases in mean difference of weight is measured after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved malnurished status of children |
after three months of interventions |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="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
|
Implementation of Educational program, Nutritional supplementations, Vitamin supplementations and preventions of infection is significant improvement in the nutritional status in terms of height, weight, mid arm circumference and overall physical growth of children. In 2022, approximately 390 million adults aged 18 years and older worldwide were underweight, while 2.5 billion were overweight, including 890 million who were living with obesity. Among children and adolescents aged 5-19 years, 390 million were overweight, including 160 million who were living with obesity. Another 190 million were living with thinness (BMI-for-age more than two standard deviations below the reference median). |