| CTRI Number |
CTRI/2023/12/060622 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Impact of Household Food Insecurity on Dietary Diversity
and Sleep Quality between Middle-Income Men and Women Aged 40 to 60 years |
|
Scientific Title of Study
|
Comparing the Impact of Household Food Insecurity on Dietary Diversity And Sleep Quality Between Middle-Income Men and Women Aged 40 to 60 yeras |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zoya Parvez Akhtar Siddiqui |
| Designation |
Students |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8097110538 |
| Fax |
|
| Email |
siddiquizoya1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinaya Vaishampayan |
| Designation |
Head of B.S.c Department and Vice Principal |
| Affiliation |
Dr.BMN College of Home Science |
| Address |
Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9967586292 |
| Fax |
|
| Email |
vinaya@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaya Vaishampayan |
| Designation |
Head of B.S.c Department and Vice Principal |
| Affiliation |
Dr.BMN College of Home Science |
| Address |
Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9967586292 |
| Fax |
|
| Email |
vinaya@bmncollege.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zoya Parvez Akhtar Siddiqui |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai, Maharashtra 400019 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 |
| Zoya Parvez Akhtar Siddiqui |
Dr. BMN College of Home Science. Department of Clinical Nutrition and Dietetics. |
Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Road, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
8097110538
siddiquizoya1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
None |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Middle Aged Adults between 40 to 60 years
Adults whose household earning is between Rs. 2 lacks to 5 lacks i.e. Middle Income Households.
Adults with no existing medical condition which can affect their food intake such as ulcers irritable bowel syndrome small intestinal bacterial overgrowth and gastroesophageal reflux disease gallstones Celiac disease Crohns disease, Ulcerative colitis.
Individuals who are willing to participate. |
|
| ExclusionCriteria |
| Details |
Female Adults who are pregnant or lactating.
Adults who are bedridden and have conditions that affect their food intake.
Adults whose household earning is less than 2 lakh.
Adults whose household earning is more than 5 lakh.
Individuals who are not willing to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of the study,
We will able to evaluate the impact of household food insecurity on dietary diversity and sleep quality in middle aged male and female
We shall be able to prepare a learning module for individuals with low food diversity and sleep quality. |
Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
30/12/2023 |
| 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="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
|
Aim: To Determine the Impact of Household Food Security on Dietary Diversity And Sleep Quality among Middle Income Male and Female Aged 40 To 60 Years.
Objectives: To compare the household food insecurity between males and females belonging to Middle Income Group To assess the degree of food insecurity among the study population using household food security survey module. To investigate the relationship between household food security and dietary diversity, using guidelines for measuring household dietary diversity. (Food and agriculture organization.) To determine whether household food security and dietary diversity are associated with sleep quality using Pittsburgh Sleep Quality Index -PSQI
Material and Method: Study Type: Descriptive Cross-sectional Study Design: Descriptive Cross-sectional Sample Method: Non-probability Convenience Sampling Sample Size: 150 Middle-aged Adults( 75 Male & 75 Females)
The following Inclusion criteria will be used to select adults for the study: Middle- Aged Adults between 40 to 60 years Adults whose household earning is between Rs. 2 lacks to 5 lacks i.e. Middle Income Households(Sharma, 2022) Adults with no existing medical condition which can affect their food intake such as ulcers, irritable bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO), and gastroesophageal reflux disease (GERD) gallstones, Celiac disease, Crohn’s disease, Ulcerative colitis. Individuals who are willing to participate.
Adults will be excluded from the study if Female Adults who are pregnant or lactating. Adults who are bedridden and have conditions that affect their food intake. Adults whose household earning is less than 2 lakh. Adults whose household earning is more than 5 lakh. Individuals who are not willing to participate. |