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CTRI Number  CTRI/2023/12/060442 [Registered on: 04/12/2023] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Behavioral
Other (Specify) [Nutrition education]  
Study Design  Single Arm Study 
Public Title of Study   Assessment of nutritional status, variety in diet and effect of nutrition education in selected school children of 11 - 14 years of Udupi city 
Scientific Title of Study   Assessment of nutritional status and dietary diversification, and impact of nutrition education in selected school going adolescents of Udupi city 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Marneni Keerthana 
Designation  Student 
Affiliation  Welcomgroup Graduate School of Hotel Administration  
Address  Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Near WGSHA hostel, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8919662095  
Fax    
Email  keerthana.wgshampl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Namratha Pai K 
Designation  Assistant Professor 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition, Graduate School of Hotel Administration, Manipal Academy of Higher Education, Near WGSHA hostel, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9738364472  
Fax    
Email  namratha.paik@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Namratha Pai K 
Designation  Assistant Professor 
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition, Graduate School of Hotel Administration, Manipal Academy of Higher Education, Near WGSHA hostel, Manipal, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9738364472  
Fax    
Email  namratha.paik@manipal.edu  
 
Source of Monetary or Material Support  
Welcomgroup Graduate School of Hotel Administration, Near Marena complex, Madhav nagar, Manipal 576104 
 
Primary Sponsor  
Name  Keerthana Marneni 
Address  Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Near WGSHA hostel, Manipal, Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namratha Pai K  AdiUdupi English Medium Higher Primary School  Udupi - Malpe road, Adi-udupi, 576103
Udupi
KARNATAKA 		 9738364472

namratha.paik@manipal.edu 
Dr Namratha Pai K   Christian High School  Taluk office road, Chitpady, 576101
Udupi
KARNATAKA 		 9738364472

namratha.paik@manipal.edu 
Dr Namratha Pai K  St Marys High School  K.M Marg, Church Compound,576101
Udupi
KARNATAKA 		 9738364472

namratha.paik@manipal.edu 
Dr Namratha Pai K   St.Cecilys High School  Brahmagiri, 576101
Udupi
KARNATAKA 		 9738364472

namratha.paik@manipal.edu 
Dr Namratha Pai K   Trinity Central School  Sundari Gate, Kallu Gudde, 576102
Udupi
KARNATAKA 		 9738364472

namratha.paik@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
AdiUdupi English Medium Higher Primary School  No Objection Certificate 
Christian High School  No Objection Certificate 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
St. Cecilys High School  No Objection Certificate 
St. Marys High School  No Objection Certificate 
Trinity Central School  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adolescents  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention group  The study focuses on assessing the nutritional status and dietary diversification of selected school going adolescents of Udupi city. 1.The following data will be collected at one time point as a baseline data: general questionnaire and 24-hour dietary recall, food frequency and dietary diversification of the subject will be recorded. 2. The following data will be collected at 2 time points i.e., before and after intervention Knowledge on nutrition and healthy food choices of the subjects  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  All the children between 11 to 14 years of age, children of all genders, and parents who have given consent for their wards participation in the study. 
 
ExclusionCriteria 
Details  Children below 11 years of age, children above 14 years, and parents who have not given consent for their wards participation in the study. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Assessment of macro- and micro-nutrient deficiencies by 24-hour recall data and food frequency. 2) The dietary diversity of food groups using the minimal dietary diversification score.
This will be followed by providing intervention through nutrition education on food choices and dietary behaviour. The parameters on knowledge of food choices and dietary behaviour will be assessed before intervention and after providing the intervention.  		 Before Intervention and After Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
The pre & post questionnaire will provide knowledge on the healthy & faulty dietary choices & behaviour among school going adolescents.  Before Intervention & After Intervention 
 
Target Sample Size   Total Sample Size="318"
Sample Size from India="318" 
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)   11/12/2023 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response (Others) -  If the journal publisher asks for submitting the informed consent and data sheet after de-identification

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Upon request to namratha.paik@manipal.edu

  6. For how long will this data be available start date provided 11-12-2023 and end date provided 11-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background - One of the major public health issues affecting children in developing nations like India is malnutrition. It is a significant hindrance to children’s growth and development. For children to develop properly on both a mental and physical level during childhood, good nourishment is essential. The triple burden of malnutrition in terms of overnutrition, undernutrition and micronutrient deficiencies in childhood and adolescence has become one of the prevailing public health problems worldwide. The need for better nutrition under sustainable development is recognized in SDG 2 which is zero hunger. Nutrition has an impact on bone health, diabetes, and obesity. Good habits are essential for well-being.

Research gap - There are very few research conducted in Karnataka that evaluates adolescents’ dietary diversity and nutritional status. This study aims to assess nutritional status and dietary diversification and the impact of nutrition education in selected school-going adolescents.

Objectives - To assess the Nutrition status and dietary diversity among school-going adolescents. To educate the children about healthy eating habits and food choices. To assess the impact of nutrition education on dietary habits and food choices in school-going adolescents of Udupi City. 

     Methodology - This study will be conducted in Udupi City, focusing on school-going adolescents aged 11 to 14 from 5 non-residential schools. Parental consent will be taken, and students will be selected randomly using a stratified sampling method (using randomization). This study will be initiated after obtaining permission from the Institutional Ethics Committee and CTRI. The study will include a general questionnaire, anthropometry measurements, clinical assessment, dietary intake, food frequency and calculating the dietary diversification score. The adolescents will be given a nutrition education program to increase their knowledge about food, food groups, food choices, nutritional needs and consequences of eating junk food. A pre-test and post-test will be conducted to assess the impact of nutritional education. 

      Expected Outcome -  The macro- and micro-nutrient deficiencies will be identified by 24-hour recall data and food frequency. The dietary diversity of food groups among school-going adolescents will be assessed using the minimal dietary diversification score. The impact of nutrition education on food choices and dietary intake will be assessed by pre and post-test analysis.





 
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