| CTRI Number |
CTRI/2022/10/046868 [Registered on: 28/10/2022] Trial Registered Prospectively |
| Last Modified On: |
28/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To know the breakfast consumption patterns and its contribution to total energy and carbohydrate, protein and fat intakes, in adolescent boys and girls (11 to 13 years) belonging to different socio-economic groups. |
|
Scientific Title of Study
|
A study on breakfast consumption patterns and its contribution to total energy and macronutrient intakes, in adolescent boys and girls (11 to 13 years) belonging to different socio-economic groups. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranali Lambole |
| Designation |
Student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr BMN College of Home Science, Department of Clinical Nutrition and dietetics Matunga Mumbai 400019
India
Mumbai MAHARASHTRA 400019 India |
| Phone |
9969398029 |
| Fax |
|
| Email |
lambolepranali@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mrs Madhavi Sathe |
| Designation |
Assistant Professor Department of Home-Economics-Nutrition and Meal Management. |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr BMN College of Home Science, Department of Clinical Nutrition and dietetics Matunga Mumbai 400019
India
Mumbai MAHARASHTRA 400019 India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mrs Madhavi Sathe |
| Designation |
Assistant Professor Department of Home-Economics-Nutrition and Meal Management. |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr BMN College of Home Science, Department of Clinical Nutrition and dietetics Matunga Mumbai 400019
India
Mumbai MAHARASHTRA 400019 India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Home Science, Matunga |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 |
| Pranali Lambole |
Seva Mandal Education Societys Institutional Ethics Committee |
Dr. BMN College of Home Science Clinical Nutrition and Dietetics Department, Rafi Ahmed Kidwai Road, Matunga , Mumbai, Maharashtra. Mumbai MAHARASHTRA |
9969398029
lambolepranali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Societys Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Female and male students between 11 to 13 years old studying in municipal and private schools
Students who are interested to participate in the study
|
|
| ExclusionCriteria |
| Details |
Students with health conditions such as Type I Diabetes mellitus, renal diseases, cancer and students below 11 years and above 13 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcome would be that the breakfast pattern, sleep pattern, physical activity, lifestyle factors, will be affecting the consumption of the school going students |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the study aims to introduce the need and importance of the healthy breakfast eating habit among the school going students and develop easy to cook and eat recipes for them |
1 year |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
31/10/2022 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Breakfast is one of the main meals of the day that affects the physical and psychological state of a person and is also known to enhance the physical fitness and the cognitive ability of an individual (Pandey & Vora, 2015) . A study carried out in Spain compared breakfast consumption and skipping among the adolescents and concluded that eating breakfast has better contribution towards health than not consuming it (Ferrer-Cascales et al., 2018). Abnormal meal patterns in children and adolescents, end with obesity and overeating and is mostly related with skipping of breakfast (Keski Rahkonen et al., 2003, Niemeier et al., 2006). Breakfast consumption pattern and the type of food groups included in breakfast varies from person to person. The variations maybe , due to one’s choices, time availability , one’s preferences, socio economic status, parental breakfast eating, family structure, number siblings, and working mothers (Levin and Kirby, 2012;) Several children attend school daily without having breakfast in both rural and urban areas. (Durgannavar & Vijayalakshmi, 2021). The breakfast preferences of the school children of different socio-economic status (SES) in twin cities of Hyderabad and Secunderabad, India, reported that the majority of children preferred traditional breakfast preparations like idly and dosa and most of the low socio-economic students tend to skip breakfast (Vijayapushpam et al.,2003). When these two studies were compared it was found that the most common reason for skipping breakfast among breakfast skippers was lack of time.The National Health and Nutrition Examination Survey (NHANES 2014) found that with the increasing number of physical activities and by not skipping meals, especially the breakfast, there are less chances among the children of being obese or overweight (Keast et al., 2009) Moreover, regular breakfast consumption has been associated with overall dietary quality and nutritional profiles in adolescents and they have shown to have improved cognitive performance in them.(Timlin et al., 2008).Of the total calories consumed in a day the breakfast should meet 25% of the total . A study on breakfast patterns in India, found that the proportion of adolescents skipping breakfast regularly was over 50% (Chitra and Reddy, 2006). Adolescents who skip breakfast daily are at higher risk of having varied meal pattern, snacking behavior and low levels of physical activity and are thus prone to obesity and overweight (Utter et al., 2007). In view of the above, it was considered of interest to find out the breakfast consumption patterns and factors such as the socioeconomic status, sleep pattern, number of hours spent on virtual media, play hours, snacking patterns, food preferences and anthropometric measures, among Indian adolescent school children. This age group was selected since adolescence is an important and final growth phase with increased nutritional requirements, especially of protein, calcium, iron, folic acid as well as increased energy demand. Smith, 2009 in his study observed that the regular frequency of breakfast among children has several health benefits which includes better weight management, low levels of LDL cholesterol, low risk of metabolic syndrome, diabetes mellitus, coronary heart disease and better digestive functioning and low chances of respiratory illness. |