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CTRI Number  CTRI/2024/03/063746 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Barriers Vs Benefits : Digital diet diary vs conventional diet diary 
Scientific Title of Study   Comparative evaluation of a digital diet diary application with existing conventional diet diary in local population 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surabhi Sinnarkar 
Designation  Post Graduate  
Affiliation  Dr D Y Patil Dental College 
Address  Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018
Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018
Pune
MAHARASHTRA
411014
India 
Phone  9623841213  
Fax    
Email  surabhi949@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilesh Rathi 
Designation  Head of the Department 
Affiliation  Dr D Y Patil Dental College 
Address  Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018
Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9960100010  
Fax    
Email  nilesh.rathi@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nilesh Rathi 
Designation  Head of the Department 
Affiliation  Dr D Y Patil Dental College 
Address  Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018
Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9623841213  
Fax    
Email  nilesh.rathi@dpu.edu.in  
 
Source of Monetary or Material Support  
D Y Patil Dental College & Hospital, pimpri, pune 411018 
 
Primary Sponsor  
Name  Dr D Y Patil Dental college Hospital 
Address  Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Surabhi Sinnarkar  Dr D Y Patil dental college and hospital  Dr D Y Patil Dental College and Hospital. dept of pediatric and preventive dentistry (dept no 8), second floor sant tukaram nagar, pimpri, pune 411018
Pune
MAHARASHTRA 		 9623841213

surabhi949@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.D.Y.Patil Vidyapeeth, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  barriers vs benefits : digital diet diary vs conventional diet diary  participants will be provided with a questionnaire after the intervention with digital diet diary and a conventional diet diary after a wash out period the intervention period will be of 15 days 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children with informed parental consent
2. Parents prepared to participate in the study
3. Parents with digital device
 
 
ExclusionCriteria 
Details  1. Children without parental consent
2. Children without provision for smartphone
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of the digital diet diary application  outcome will be assessed post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the digital diet diary application with the existing conventional diet diary.

 		 2 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
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
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [surabhi949@gmail.com].

  6. For how long will this data be available start date provided 17-02-2024 and end date provided 17-02-2025?
    Response - Immediately following publication. No end date.

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

Pediatric dental professionals should routinely give patients nutritional advice and use diet diaries as a tool for diet assessment in children.  Diet diary helps in recording the between meal and total sugar exposure of children and their risk of development of dental caries. However, there is a major lacunae when it comes to journaling the diet of Indian population due to its  high variability depending upon the region, culture and socioeconomic status . In order for parents to understand and make healthier and sustainable diets more available, affordable, and acceptable, educating them through the diet diary plays an important role. A novel smartphone application has been studied to show effective results in Indian population. Thus, the aim of this study is comparative evaluation of a novel smartphone diet diary application with existing conventional diet diary in local population

 
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