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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 

 
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