| CTRI Number |
CTRI/2024/04/065717 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NUTRITION EDUCATION INTERVENTION] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nutrition Education Intervention Program to prevent Iron Deficiency Anemia Among Adolescent Girls |
|
Scientific Title of Study
|
Development of School-Based Nutrition Education Intervention Program to Prevent Iron Deficiency Anemia among Adolescent Girls |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPriyanka Pareek |
| Designation |
Assistant Professor and HOD Department of Clinical Nutrition |
| Affiliation |
MGM School of Biomedical Sciences MGM Institute of Health Sciences Navi Mumbai |
| Address |
Department of Clinical nutrition, forth floor,MGM Medical college building,MGM School of Biomedical Sciences MGM Institute of Health Sciences Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410206
India |
| Phone |
8143640995 |
| Fax |
|
| Email |
priyankapareekcn1681@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPriyanka Pareek |
| Designation |
Assistant Professor and HOD Department of Clinical Nutrition |
| Affiliation |
MGM School of Biomedical Sciences MGM Institute of Health Sciences Navi Mumbai |
| Address |
Department of Clinical nutrition, forth floor,MGM Medical college building, MGM School of Biomedical Sciences MGM Institute of Health Sciences Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410206
India |
| Phone |
8143640995 |
| Fax |
|
| Email |
priyankapareekcn1681@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chethana C |
| Designation |
PhD Scholar |
| Affiliation |
MGM School of Biomedical Sciences, MGM Institute of Health Sciences, Navi Mumbai |
| Address |
Department of Clinical nutrition, forth floor,MGM Medical college building, MGM Institute of Health Sciences Sector-1 Kamothe Navi Mumbai
Raigarh
MAHARASHTRA
410206
India |
| Phone |
9843447346 |
| Fax |
|
| Email |
chethana.rd@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences, Kamothe,Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr.Priyanka Pareek |
| Address |
MGM School of Biomedical Sciences MGM Institute of Health Sciences Kamothe Navi Mumbai |
| 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 |
| Mrs Ujwala Bakal |
Mahatma Gandhi Mission Primary and Secondary School Nerul, English and Marathi Medium |
Mahatma Gandhi Mission Primary and Secondary School Sector-8 Phase-II, Nerul(West), Navi Mumbai
Thane
MAHARASHTRA |
022-2775129
mgmschoolnerul@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adolescent girls |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
nutrition education 6 months |
nutrition education on iron and iron deficiency anemia for 6 months |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls who are willing to participate in the study
Adolescent girls post 6 months of menarche
Adolescent girls with haemoglobin ≥ 12g/dl
|
|
| ExclusionCriteria |
| Details |
Adolescent girls with hemoglobinopathies
Adolescent girls taking Iron Folic Acid Supplementation
Adolescent girls with history of any chronic diseases gastrointestinal disorders kidney diseases liver diseases Diabetes will be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Knowledge attitude and practices related to iron deficiency anemia among adolescent girls
Nutrition related behavior Change in adolescent girls
|
6 months post nutrition education intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in iron status of adolescent girls post nutrition education intervention |
6 months post nutrition education intervention |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="108" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
15/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Pre and Post test design study focuses on assessment of nutritional status, Knowledge Attitude, Practices and nutrition related behavior of iron deficiency anemia among adolescent girls. Followed by which planning and implementation of nutrition education intervention for duration of 6months and then assess the impact of the same on the foresaid baseline parameters. This study will help in understanding the effectiveness of comprehensive nutrition education in order to prevent iron deficiency anemia among the adolescent girls. |