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CTRI Number  CTRI/2022/08/044526 [Registered on: 01/08/2022] Trial Registered Prospectively
Last Modified On: 29/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [health education ]  
Study Design  Single Arm Study 
Public Title of Study   Explaining about healthy eating and gut microbiota to ten-to-twelve-year school going children of Rishikesh 
Scientific Title of Study   क ख and ग of healthy eating and gut microbiome: A Pre-Post intervention study on healthy eating with knowledge and attitudes towards nutrition in ten-to-twelve-year school going children of Rishikesh 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manisha Naithani  
Designation  Additional Professor  
Affiliation  AIIMS Rishikesh  
Address  Additional Professor Department of Biochemistry AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000296  
Fax    
Email  manisha.bchem@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manisha Naithani  
Designation  Additional Professor  
Affiliation  AIIMS Rishikesh  
Address  Additional Professor Department of Biochemistry AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000296  
Fax    
Email  manisha.bchem@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Manisha Naithani  
Designation  Additional Professor  
Affiliation  AIIMS Rishikesh  
Address  Additional Professor Department of Biochemistry AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8475000296  
Fax    
Email  manisha.bchem@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
Uttarakhand Science Education Research Centre Uttarakhand USERC 
 
Primary Sponsor  
Name  Uttarakhand Science Education Research Centre Uttarakhand USERC 
Address  33, Phase-II, Vasant Vihar, Kanwali Rd, Vasant Vihar Phase 2, Raj Vihar, Balliwala, Dehradun, Uttarakhand 248006 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
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 
Dr Manisha Naithani  AIIMS Rishikesh   A3, Level 3, Department of Biochemistry, AIIMS Rishikesh
Dehradun
UTTARANCHAL 		 8475000296

manisha.bchem@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School going children of age between 10-12 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nutritional education intervention  Table1: Topics and details of the education program Nutrition Topic Duration Part 1 Nutrients important in the diet Goal Shaping pro-healthy dietary habits. Scope A balanced diet for early adolescents. Health consequences of consuming unhealthy diet. Methods Talk and discussion 20 minutes Activities Participants propose three various “healthy” breakfasts to take at school by selecting foods from a level of the Pyramid of Healthy Nutrition and Physical Activity; Participants choose an “ideal meal” from various photographs of food items. Tools Handouts on balanced diet, play activity specifically designed to identify ideal balanced diet 10 minutes Part 2 Gut microbiota: importance and effects Goal Introduction to gut microbiome concept and its link to health Scope The impact of probiotics in maintaining gut microbiome balance. What are heathy probiotic rich foods? Methods Talk; discussion 20 minutes Tools Handouts on gut microbiome, play activity specifically designed to identify probiotic containing food items 10 minutes  
Comparator Agent  nutritional education intervention.   No comparator arm  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Participant inclusion criteria:
Age between 10-12 years
Fifth, sixth and seventh grade classes of elementary school.
No disability, self-declared by parent or legal guardian or teacher. Written consent of parents or legal guardians to participate.
 
 
ExclusionCriteria 
Details  Participant exclusion criteria
For the education-based intervention study:
Age more than 12 years at initiation of study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Knowledge related to nutrition and gut microbiota   3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Change in attitude towards nutrition  3 months 
 
Target Sample Size   Total Sample Size="744"
Sample Size from India="744" 
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)   01/08/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Globally, millions of children and adolescents are victims of obesity as a result of inclusion of junk food in their diet. In this regard, the change in nutrients found in food has been shown to be responsible for the burden of obesity. In India, changes in food culture have been significant over the past decade. This is particularly found among the adolescents. Previous surveys have shown that adolescents have low knowledge of proper food and its consequences; thus, the majority of them were at risk of eating of junk food. In addition, the consumption of junk food varied by age; it was found that the higher proportion of junk food was in early adolescents (93%) as compared to late adolescents (89%). This difference in the consumption of junk food is determined by the taste and availability and by home and environmental factors. Hence, gaining knowledge of nutrition can be beneficial in improving the health and well-being of adolescents and individuals. The present aims to increase nutritional knowledge and awareness in early adolescent school going children of Rishikesh by nutrition-related education program to pre-adolescent school children. Project would be initiated after Institutional ethical approval. This study would include 10-12 Government/ Government aided/ private school of Rishikesh. Selection of different type of schools would be ensured to know effect of socio-demographic factors. Permission to conduct this intervention study would be sought by competent authority in schools. We would also like to determine the association between early adolescent school going children’s nutrition knowledge, attitudes toward nutrition, dietary and lifestyle

behaviours, and body anthropometry. The study will be explained to the participants before the start (verbally and by leaflets), to the pupils at the school lessons and to the parents/legal guardians during the meetings. Parental or legal guardians’ written informed consent will be obtained for the participation of their children. This project aims to increase nutritional knowledge and awareness in early adolescent school going children of Rishikesh by nutrition-related education program and also provide diet counselling. It would also help us find the association between early adolescent school going children’s nutrition knowledge, attitudes toward nutrition, dietary and lifestyle behaviours, and body anthropometry.

 
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