| CTRI Number |
CTRI/2024/10/075353 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Nutrition Education] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the eating habits and nutritional gaps of pregnant women in rural central India and providing health education to increase awareness about care of mother during pregnancy. |
|
Scientific Title of Study
|
Evaluating the local food palette and nutritional deficit of pregnant women in rural central India
and administering health educational intervention.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshan Prasad |
| Designation |
Medical Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynaecology, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
6299989676 |
| Fax |
|
| Email |
roshanprasad2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Atul Tayade |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynaecology, AVBRH Building, Sawangi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887519832 |
| Fax |
|
| Email |
surobgy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surekha Atul Tayade |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynaecology, AVBRH Building, Sawangi, Meghe
MAHARASHTRA
442001
India |
| Phone |
7887519832 |
| Fax |
|
| Email |
surobgy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
New Delhi, India, 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Datta Meghe Institute of Higher Education and Research |
Sawangi, Meghe, Wardha, India, 442001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Roshan Prasad |
Datta Meghe Institute of Higher Education and Research |
Department of Obstetrics and Gynaecology, AVBRH Building, Sawangi, Meghe, Wardha, India, 442001
Wardha
MAHARASHTRA |
6299989676
roshanprasad2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women reporting to Department of OBGY will be enrolled in the study.
24-hour diet recall, BMI, Hemoglobin, Total Protein will be evaluated. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Education about nutrition. |
Educational interventions and nutritional health advice will be offered to the participant regarding the type of food required per the week of gestation, considering
their economic status with help of small group discussion
aided with picture representations, posters and charts.
The total duration of intervention will be 2 months.
|
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women who gave written consent.
2. Low-risk pregnant women with Singleton pregnancies.
3. Pregnant women up to 28 weeks of gestation. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women with any pre-existing co-morbidities.
2. Pregnant women who were exceeding 28 weeks of pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge and awareness about nutrition during pregnancy. |
Assessment will be done at the end of 2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The key to good health is a balanced diet consisting of fruits, vegetables, dairy products, grains and pulses, providing appropriate carbohydrates, proteins, fats and minerals. On average, a healthy female needs nearly 1500-2500 calories per day to maintain their weight and good health. In comparison, a pregnant female needs more nutrients for the growing foetus, so her nutritional demands increase by 300-400 calories. Thus, pregnant women should be aware of this additional need and must understand strategies to meet this demand for calories and energy for successful pregnancy outcome.
This study aims to evaluate the food pattern of pregnant women, dietary deficiencies in calorie and macronutrients and planning of an appropriate educational intervention. |