| CTRI Number |
CTRI/2024/07/071090 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of short-term outcomes of varied dietary interventions in Antenatal women |
|
Scientific Title of Study
|
Comparison of short-term outcomes of varied dietary interventions in Antenatal women of two geographically distinct Primary Health Centres |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naman Pujeri |
| Designation |
MBBS Student |
| Affiliation |
Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College |
| Address |
Department of Community Medicine
JGMM Medical College Hubballi
Gabbur Cross Kotagondhunshi Hubballi
Dharwad
KARNATAKA
580028
India |
| Phone |
9113853744 |
| Fax |
|
| Email |
namanpujeri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Kumar |
| Designation |
Professor and HOD |
| Affiliation |
Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College |
| Address |
Department of Community Medicine Gabbur Cross Kotagondhunshi Hubballi
Dharwad
KARNATAKA
580028
India |
| Phone |
7026288455 |
| Fax |
|
| Email |
docsaurabh777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Kumar |
| Designation |
Professor and HOD |
| Affiliation |
Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College |
| Address |
Department of Community Medicine Gabbur Cross Kotagondhunshi Hubballi
Dharwad
KARNATAKA
580028
India |
| Phone |
7026288455 |
| Fax |
|
| Email |
docsaurabh777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College, Hubballi, Karnataka-580028, India |
|
|
Primary Sponsor
|
| Name |
Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College |
| Address |
Gabbur Cross Kotagondhunshi Hubballi-580028 Karnataka, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Kumar |
JGMMMC |
Department of Community Medicine- Family Adoption PHC Adargunchi
Dharwad
KARNATAKA |
7026288455
docsaurabh777@gmail.com |
| Dr Saurabh Kumar |
JGMMMC |
Department of Community Medicine- Rural Health Training Centre- PHC Noolvi
Dharwad
KARNATAKA |
7026288455
docsaurabh777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JGMM Medical College Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Antenatal Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dietary Charts |
The eligible ANCs will be given validated dietary charts as per the National Institute of Nutrition Guidelines. Dietary Charts will be given only once |
| Intervention |
Dietary Health Education |
Dietary Health education session to all the eligible ANCs on Thursday(Weekly ANC Day at the PHCs) regarding Dietary Interventions in one PHC Area(Intervention will be done only once) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal Women consenting to be a part of the study |
|
| ExclusionCriteria |
| Details |
Antenatal women with comorbid conditions like Diabetes mellitus heart diseases hypothyroidism
Antenatal women with multiple pregnancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the weight gain between the two groups will be done |
8 weeks/ 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the compliance of dietary interventions in the Antenatal women in two distinct intervention arms |
2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
08/08/2024 |
| 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 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
|
Primary Objectives 1. To describe the sociodemographic profile of the Antenatal women in two distinct intervention arms 2. To calculate the mean difference in weight gain in the Antenatal women in two distinct intervention arms Secondary Objectives: 1. To assess the compliance of dietary interventions in the Antenatal women in two distinct intervention arms Methodology Study design: Quasi-experimental field trial Study Duration: 2 months from the Institution Ethics Committee Approval Study Area: Primary Health Centre, Adargunchi and Primary Health Centre, Noolvi Study population: Antenatal mothers in II trimester Exclusion Criteria: Antenatal mothers with high-risk pregnancy Sample size: Assuming hypothetical mean difference in the weight gain by ANCs as .6kg at the end of two months after the intervention and with Standard Deviation as 0.8 and 0.7 respectively in the two arms, taking alpha error as .05 and Beta error as 0.02, the sample size comes out to be 25 in each arm Study Plan: 25 ANCs will be selected purposively in PHC Adargunchi and PHC Noolvi catchment areas. PHC Noolvi is affiliated to our institution as the Rural Health Training Centre(RHTC) and PHC Adargunchi has been adopted for the family adoption. The catchment areas of the PHCs are geographically distinct. Baseline weight of study population will be assessed before the dietary interventions. We will be giving a Health education session to all the eligible ANCs on Thursday(Weekly ANC Day at the PHCs) regarding Dietary Interventions in PHC Adargunchi. In PHC Noolvi, the eligible ANCs will be given dietary charts as per the National Institute of Nutrition Guidelines. The Dietary charts will be validated by Nutritionist of the Medical College Hospital and will be customised as per the local food habits. Weight of the study population will be done again at the end of 2 months after the intervention. Comparison of the weight gain between the two groups will be done at the end of 2 months. Weight measurement will be done as per the WHO Guidelines using an Electronic Weighing Scale. |