| CTRI Number |
CTRI/2024/12/078716 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary modification] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of diet on weight gain in pregnancy |
|
Scientific Title of Study
|
To Evaluate the Effect of Dietary Intervention on Gestational Weight Gain among Pregnant Women: A Randomised Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepali Garg |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no.710 MCH Block, All India Institute of Medical Sciences Ansari Nagar, New Delhi-110029
South West
DELHI
110029
India |
| Phone |
9818706660 |
| Fax |
|
| Email |
drdeepaligarg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamini JR Gyane |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Ansari Nagar, New Delhi |
| Address |
Room no.710 MCH Block, All India Institute of Medical Sciences Ansari Nagar, New Delhi-110029
South West
DELHI
110029
India |
| Phone |
7052370844 |
| Fax |
7052370844 |
| Email |
ladylinkin14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamini JR Gyane |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Ansari Nagar, New Delhi |
| Address |
Room no.710 MCH Block, All India Institute of Medical Sciences Ansari Nagar, New Delhi-110029
South West
DELHI
110029
India |
| Phone |
7052370844 |
| Fax |
7052370844 |
| Email |
ladylinkin14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gyanecology, All India Institute of Medical Sciences, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Kamini |
| Address |
Room No. 710 Mother and Child Block, Department of Obstetrics and Gyanecology, All India Institute of Medical Sciences, New Delhi 110029 |
| Type of Sponsor |
Other [Present study is thesis in partial fulfilment of the requirement for the degree of MD ] |
|
|
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 |
| Dr Deepali Garg |
All India Institute Of Medical Sciences Delhi |
OPD room no. 9, Mother and Child Block, AIIMS, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
Central
DELHI |
9818706660
drdeepaligarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z713||Dietary counseling and surveillance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dietary Intervention |
In addition to routine antenatal care, a structured trimester specific dietary advice chart will be provided at the time of recruitment and then at the beginning of each trimester it will be revised. These women will be followed telephonically every 4-weekly thereafter to reinforce the compliance towards the dietary advices. A 24-hour dietary recall will be used to calculate nutrient intake in each trimester till delivery in each trimester. Weight assessment will be done at the time of recruitment, at 28 week and at the time of delivery. |
| Comparator Agent |
Standard Routine Care |
In this group routine antenatal care will be provided. 24-hour dietary recall will be used to calculate nutrient intake in each trimester till delivery. Weight assessment will be done at the time of recruitment, at 28 week, at the time of delivery. Gestational weight changes, nutrient intake, maternal and neonatal outcomes will be noted in a working Case record form.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Weight assessment will be done at the time of recruitment, at 28 week at the time of delivery. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give an informed written consent
2. Multiple pregnancy
3. Pre-existing medical/ surgical condition that might affect body weight
4. Subjects in other interventional study
5. On other dietary or lifestyle interventions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean weight gain in kg
|
Weight assessment will be done at the time of recruitment, at 28 week at the time of delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean total calorie intake in Kcal
Mean carbohydrate intake in gm
Mean protein intake in gm
Mean fat intake in gm
Incidences of preterm labour fetal growth restriction pre-eclampsia or gestational hypertension gestational diabetes mellitus anaemia wound infection induction of labour
Percentage undergoing vaginal delivery, instrumental delivery, caesarean section
Incidences of Apgar score less than 7, NICU admission SGA AGA LGA, Birth asphyxia |
Weight assessment will be done at the time of recruitment, at 28 week at the time of delivery |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/01/2025 |
| 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="2"
Months="0"
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
|
Gestational weight gain (GWG) refers to weight gained during pregnancy, encompassing maternal components, placental mass, and fetal weight. It is influenced by social, environmental, and maternal factors. Inadequate GWG is linked to risks such as stillbirth, small for gestational age, and preterm birth, while excessive GWG increases risks of macrosomia, cesarean delivery, and postpartum weight retention. Recommendations for GWG vary by pre-pregnancy BMI. TThis randomized controlled trial evaluates the impact of dietary interventions on gestational weight gain (GWG) among pregnant women attending a tertiary care center in North India. The study involves two groups: an intervention group receiving structured trimester-specific dietary advice with regular follow-ups, and a control group receiving standard antenatal care with dietary suggestions via brochures. Key outcomes include GWG, nutrient intake, maternal, and neonatal outcomes. Anthropometric measurements and dietary intake are assessed periodically, following Indian Council of Medical Research guidelines. Findings aim to provide insights into dietary management during pregnancy, optimizing maternal and neonatal health outcomes. |