| CTRI Number |
CTRI/2025/04/085743 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How eating habits , Body image views , Sleep quality and depression during and after pregnancy are related which eachother during pregnancy. |
|
Scientific Title of Study
|
Relation between Eating behavior, Body image perceptions, Sleep quality and Peripartum depression during Pregnancy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Subicha T S |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22, SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus chengalpattu district
Chennai
TAMIL NADU
603203
India |
| Phone |
7200337170 |
| Fax |
|
| Email |
subichat@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Riti Shah |
| Designation |
PG student |
| Affiliation |
SRM Medical college |
| Address |
PT-22, SRM College of Physiotherapy, SRM Medical college, Kattankulathur campus chengalpattu district
Chennai
TAMIL NADU
603203
India |
| Phone |
8780960189 |
| Fax |
|
| Email |
rs8323@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Subicha T S |
| Designation |
Assistant Professor |
| Affiliation |
SRM College of Physiotherapy |
| Address |
PT-22, SRM College of Physiotherapy, SRM Medical college, Kattankulathur campus chengalpattu district
Chennai
TAMIL NADU
603203
India |
| Phone |
7200337170 |
| Fax |
|
| Email |
subichat@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy
Kattankulathur campus
Chengalpattu district, TN-603203 |
|
|
Primary Sponsor
|
| Name |
SRM College of Physiotherapy |
| Address |
Kattankulathur campus chengalpattu district , TN - 603203 |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 Subicha T S |
SRM College of Physiotherapy |
PT-22, SRM College of Physiotherapy, SRM Medical College, Kattankulathur campus chengalpattu district
Chennai
TAMIL NADU |
07200337170
subichat@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
more than 18 years old, Third trimester, Primigravida, Participants who are willing to participant, Participant who score more than 13 in Edinburgh Postnatal Depression scale(EPDS) |
|
| ExclusionCriteria |
| Details |
High risk pregnancies, Cardiovascular disorder, Eclampsia or Pre- eclampsia patients, Gestational Diabetes Mellitus, Multiple pregnancies, Hypothyroidism |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Edinburgh Postnatal Depression Scale |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Three factor eating questionnaire R-18, Body Shape Questionnaire, Pittsburgh Sleep Quality Index |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="193"
Sample Size from India="193"
Final Enrollment numbers achieved (Total)= "199"
Final Enrollment numbers achieved (India)="199" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/05/2025 |
| Date of Study Completion (India) |
07/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
07/08/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to explore the relationship between eating behavior, body image perceptions, sleep quality and peripartum depression among pregnant women. Pregnant participants would be assessed during third trimester using Edinburgh Postnatal Depression scale (EPDS), Three factor eating questionnaire R-18, Body Shape Questionnaire, Pittsburgh Sleep Quality Index (PSQI). To provide insights that could inform interventions aimed at managing mental health through lifestyle modifications after pregnancy. The findings may contribute to the existing literature on maternal health, emphasizing the importance of nutrition and sleep during pregnancy. |