| CTRI Number |
CTRI/2025/07/091680 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Link Between Breakfast Quality and Anxiety in Female College Students Aged 18–22 |
|
Scientific Title of Study
|
Impact of Breakfast Quality(quality of proteins) on the Anxiety Levels of undergraduate college students using the Halford and Frost scale
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishita Ashwin Mistry |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Divya Rishi Apartemnt,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai -400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9324294213 |
| Fax |
|
| Email |
ishitamistry10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of Department |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Divya Rishi Apartemnt,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai -400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of Department |
| Affiliation |
Dr. BMN College of Home Science |
| Address |
Divya Rishi Apartemnt,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai -400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| DR BMN College of Home Science |
|
|
Primary Sponsor
|
| Name |
Ishita Ashwin Mistry |
| Address |
Divya Rishi Apartemnt,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai -400019
|
| 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 |
| Dr Rupali Sengupta |
Dr BMN College of Home Science |
Divya Rishi Apartemnt,338, Rafi Ahmed Kidwai Road, Matunga, Mumbai -400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.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 |
Individuals with no diseased conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Observational study, no intervention is involved |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Female |
| Details |
Female participants aged 18 - 22 years
Undergraduate enrolled in a college or university
Willing to participate
|
|
| ExclusionCriteria |
| Details |
Female participants less than 18 years and more than 22 years
Not enrolled in a college or university
Not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between Breakfast Quality (with emphasis on protein quality using DIAAS) and Anxiety Levels among undergraduate female college students using Halford and Frost Scale (DASS-10). |
Baseline (Single time point during study period)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of breakfast consumption patterns and overall dietary patterns using the Food and Nutrition Technical Assistance (FANTA) Minimum Dietary Diversity for Women (MDD-W) tool, assessment of breakfast quality using the Breakfast Quality Index (Monteagudo et al., 2013), and protein quality using Digestible Indispensable Amino Acid Score (DIAAS) for Indian foods among undergraduate female college students |
Baseline (Single time point during study period)
|
|
|
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)
|
04/08/2025 |
| 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="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
|
This observational study aims to examine the impact of breakfast quality on anxiety levels among undergraduate female college students aged 18–22 years. The study will assess breakfast consumption patterns using a Breakfast Survey Questionnaire and classify overall dietary patterns using the Food and Nutrition Technical Assistance (FANTA) Minimum Dietary Diversity for Women (MDD-W) tool. Breakfast quality will be evaluated using the Breakfast Quality Index (Monteagudo et al., 2013), and protein quality will be assessed through the Digestible Indispensable Amino Acid Score (DIAAS) for Indian foods. Anxiety levels will be measured using the Depression Anxiety Stress Scale-10 (DASS-10) by Halford & Frost (2021). A total of 150 participants will be recruited using purposive sampling. Findings from this study will provide insights into the relationship between breakfast quality, protein adequacy, dietary diversity, and mental health among young adults. |