| CTRI Number |
CTRI/2018/05/013623 [Registered on: 03/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutrition Education Programme] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessment of Nutritional Awareness and Effect of Nutritional Education Programme NEP among Household Maids in Mumbai |
|
Scientific Title of Study
|
Assessment of Nutritional Awareness and Effect of Nutritional Education Programme (NEP) among Household Maids in Mumbai |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Jagiasi |
| Designation |
Student |
| Affiliation |
Dr BMN College of Science |
| Address |
Bk no 205 Sai Vasan Shah Darbar Section 36 Ulhasnagar
Nil
Thane
MAHARASHTRA
421005
India |
| Phone |
8600455220 |
| Fax |
- |
| Email |
jagiasipooja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Proffesor |
| Affiliation |
Dr BMN College of Science |
| Address |
338 Rafiq Ahmed Kidwai Road Matunga Mumbai
Nil
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
- |
| Email |
senguptarupali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Proffesor |
| Affiliation |
Dr BMN College of Science |
| Address |
338 Rafiq Ahmed Kidwai Road Matunga Mumbai
Nil
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
- |
| Email |
senguptarupali@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [-] |
|
|
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 |
| Pooja Jagiasi |
Dharavi |
Tata Power Lane Sion
Mumbai
MAHARASHTRA |
8600455220
-
jagiasipooja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nutrition education programme |
detailed education will be given related to importance of nutrition,food habits, food choices |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
total 100 housemaids women residing in mumbai city were included. |
|
| ExclusionCriteria |
| Details |
Samples below 30 years and above 45 years were not included in the study.
Also, women not working as housemaids were excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional education program may have significant impact on the study group |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Due to nutrional education program there may be an improvement in food choices among the study group |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 1 |
|
Date of First Enrollment (India)
|
19/09/2017 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background and Objectives: Women domestic servants or maidservants constitute an
important segment of unorganized labor of our country. The maidservants were
mostly engaged in heavy and more labor consuming household chores. Lack of
nutritional status and food availability due to effect of socioeconomic status
made them prone to many health related problems. The purpose of study was to
assess the Anthropometric measurements, nutritional status and to aware
housemaids about the importance of nutrition.
Method: With
the help of purposive sampling technique, a study was conducted on 100 samples
and Anthropometric measurements were taken before and after Nutrition Education Programme sessions.
Dietary intake and pattern was assessed with the help of food frequency questionnaire
and the data was compared. Hypothesis: The nutritional intake among the housemaids is adequate and there is no influence of nutritional knowledge on nutritional intake among them. Expected Outcome: There may be a significant impact of Nutrition Education Programme on the dietary pattern of household maids in Mumbai |