| CTRI Number |
CTRI/2022/04/041829 [Registered on: 12/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Menstruation Related Distress on Eating Behaviour of Young Females (18-35 years) |
|
Scientific Title of Study
|
A Study on Premenstrual and Menstrual Distress and Eating Behaviour among Young Females (18-35 years) |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Nidhi Bait |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Department of Clinical Nutrition and Dietetics 9 floor 338 Rafi Ahmed Kidwai road Matunga East
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7710983355 |
| Fax |
|
| Email |
nidhibait3599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Madhavi Sathe |
| Designation |
Assistant Professor |
| Affiliation |
Smt MMP Shah Womens College of Arts and Commerce |
| Address |
Department of Home economics 338 Rafi Ahmed Kidwai road Matunga East
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Nidhi Bait |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
338 Rafi Ahmed Kidwai road Matunga East
Mumbai
MAHARASHTRA
400019
India |
| Phone |
7710983355 |
| Fax |
|
| Email |
nidhibait3599@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Home Science Department of Clinical Nutrition and Dietetics 338 Rafi Ahmed Kidwai Road Matunga East 400019 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| 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 |
| Ms Nidhi Bait |
Dr BMN College of Home Science |
Department of Clinical Nutrition and Dietetics 9 floor 338 Rafi Ahmed Kidwai road Matunga East
Mumbai
MAHARASHTRA |
7710983355
nidhibait3599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premenstrual distress and menstrual distress |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Healthy young working and non working women from upper middle socio economic group between the age 18 to 35 years |
|
| ExclusionCriteria |
| Details |
Women who have been pregnant or lactating at the time of recruitment women who are pregnant at the time of recruitment and have been diagnosed with conditions like endometriosis fibroids anemia adenomyosis hypothyroidism and hyperthyroidism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the type and severity of premenstrual and menstrual distress experienced by the women between 18 35 years and gain information about the food choices made by them while experiencing this distress |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/04/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study:To determine the symptoms associated with premenstrual and menstrual distress in the age group of 18-35 years and to study the changes in their eating behaviour during the premenstrual and menstrual period.
Objectives: 1) To determine the symptoms of premenstrual and menstrual distress experienced by the study group. 2) To study the changes in eating behaviour of women between 18-35 years during the premenstrual and menstrual stages. 3) To find out if there is any association between premenstrual and menstrual distress and eating behavior in the study group.
Hence this study will be undertaken to identify the symptoms of premenstrual distress and menstrual distress experienced by women in the age group of 18-35 years and to note changes in eating behaviour during these periods. |