| CTRI Number |
CTRI/2021/01/030205 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
29/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk factors of malnutrition and effectiveness of family based intervention program (FBIP) on nutritional status of children and knowledge and practices of mothers |
|
Scientific Title of Study
|
A study on risk factors of malnutrition and effectiveness of family based intervention program (FBIP) on nutritional status of children and knowledge and practices of mothers in selected villages of Nainital district, Uttarakhand. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratiti Haldar |
| Designation |
Ph.D. Scholar |
| Affiliation |
Swami Rama, Himalayan University |
| Address |
Department of Nursing,
Swami Rama Himalayan University
Swami Ram Nagar
Near Jolly grant Airport Doiwala
Dehradun
Uttarakhand
Department of Nursing,
Swami Rama Himalayan University
Swami Ram Nagar
Near Jolly grant Airport Doiwala
Dehradun
Uttarakhand
Dehradun
UTTARANCHAL
248016
India |
| Phone |
8909383535 |
| Fax |
|
| Email |
beliealwz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lekha Viswanath |
| Designation |
Professor |
| Affiliation |
Swami Rama, Himalayan University |
| Address |
Head of Obstetrics and Gynaecological Nursing,
Nursing department,
Swami Rama Himalayan University
Swami Ram Nagar
Near Jolly grant Airport Doiwala
Dehradun
Uttarakhand
Head of Obstetrics and Gynaecological Nursing,
Nursing department,
Swami Rama Himalayan University
Swami Ram Nagar
Near Jolly grant Airport Doiwala
Dehradun
Uttarakhandd
Dehradun
UTTARANCHAL
248016
India |
| Phone |
8628030391 |
| Fax |
|
| Email |
lekhaviswanath@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lekha Viswanath |
| Designation |
Professor |
| Affiliation |
Swami Rama, Himalayan University |
| Address |
Head of Obstetrics and Gynaecological Nursing,
Nursing department,
Swami Rama Himalayan University
Swami Ram Nagar
Near Jolly grant Airport Doiwala
Dehradun
Uttarakhand
Head of Obstetrics and Gynaecological Nursing,
Nursing department,
Swami Rama Himalayan University
Swami Ram Nagar
Near Jolly grant Airport Doiwala
Dehradun
Uttarakhandd
Dehradun
UTTARANCHAL
248016
India |
| Phone |
8628030391 |
| Fax |
|
| Email |
lekhaviswanath@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
| Pratiti Haldar
Ph.D Scholar
Swami Rama Himalayan University
Swami Ram Nagar
Jolly Grant, Dehradun , Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Pratiti Haldar |
| Address |
Ph.D. Scholar,Swami Rama Himalayan University,
Swami Ram Nagar,
Doiwala,Jolly Grant, Dehradun, Uttarakhand. |
| Type of Sponsor |
Other [Self Funding ] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pratiti Haldar |
Haldwani block |
Haldwani block, Uttarakhand
Area of Study: Selected sub centres of Haldwani block, Uttarakhand
Nainital
UTTARANCHAL |
8909383535
0
beliealwz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swami Rama Himalayan University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Identified mild to moderate malnourished children |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family Based Intervention program |
Family based intervention program (FBIP) refers to multi- component training program which will be prepared by the researcher. It is designed to provide information to the mothers and family members in a group of (7-10) regarding malnutrition and its prevention in under five children (1-3) years by them.
Purpose of FBIP: The main purpose of this program will aim in improvement of nutritional status of the children (1-3) years thereby enhancing knowledge and nutrition related practices of their mothers.
Key Feature of FBIP: - Enhances the knowledge of mothers regarding use of locally available food items - Increases the competency of mothers in identifying and selecting nutritious food for their children - Improves the nutritional status - Nutritional Poster/ Chart - Information booklet
Components:
Teaching, Assessment and diet.
|
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Phase I & II
1. Children belonging to the age group of one to three years and having mild to moderate malnutrition.
2. Availability of the children at the time of data collection
3. Mothers who are willing to participate in the study.
4. Mothers who will be able to understand Hindi language.
|
|
| ExclusionCriteria |
| Details |
Phase II:
1. Mothers who are mentally challenged.
2. Children having congenital deformities like mal absorption syndrome, celiac diseases and lactose intolerance, down syndrome and pierre robin syndrome, cleft lip and cleft palate, tracheoesophageal fistula, congenital dysplasia of hip and cerebral palsy.
3. Children with severe malnutrition or undergoing any kind of treatment for malnutrition.
4. Children who are not staying with biological mother.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional status |
3 month
6 month
9 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge and Practices related to Nutrition of mothers |
1 month
3 month
6 month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "143"
Final Enrollment numbers achieved (India)="143" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/01/2021 |
| Date of Study Completion (India) |
18/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Part of the study is published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In the present study, screening of nutritional status was done in children aged (1-3) years in selected sub centres. The selected sub centres will be randomized into intervention and control group and the identified malnourished children in intervention group (sub centres) will be given family based intervention program (educational program inclusive of teaching and demonstration and distribution of posters). After 9 months the wait list control group will also be given intervention. Knowledge and practices relating to nutrition of mothers of identified malnourished children will be assessment during 1st month, 3rd month and 6th month for both intervention and control group. Weight, height and MUAC will checked in identified malnourished children 3rd month, 6th month and 9th month for both intervention and control group.
Nutritional status of children in the age (1-3) years was assessed and the mothers of identified malnourished children were randomized into intervention and control group. Family based intervention was delivered to the mothers (educational program inclusive of teaching and demonstration and distribution of posters) of intervention group in the month of February 2021 and first week of March 2021. At one month post test was conducted in both the intervention and control group in month of April. Followed by which follow up visit was done in the month of June (3rd month), September (6th month) and December 2021 (9th Month).
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