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CTRI Number  CTRI/2024/09/073469 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Game related and social media-based lifestyle modification for metabolic syndrome 
Scientific Title of Study   Effectiveness of Gamification and social-media based lifestyle modification package (GSLMP) on metabolic syndrome risk factors and health promoting behaviours among the UG students-Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B. CYNOSURE SHARMA 
Designation  ASSISTANT PROFESSOR 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  3rd Floor, Faculty of Nursing Block, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai.
Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu
Kancheepuram
TAMIL NADU
600125
India 
Phone  07010012763  
Fax    
Email  sharmacynosure3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  BRAHMACHARIMAYUM CYNOSURE SHARMA 
Designation  PhD Scholar 
Affiliation  Sri Ramachandra Institute of Higher education 
Address  3rd Floor, Faculty of Nursing Block, Ramachandra Institute of Higher Education and Research, Porur, Chennai
Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai

TAMIL NADU
600125
India 
Phone  07010012763  
Fax    
Email  brahmacharimayumcynosuresharma@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  BRAHMACHARIMAYUM CYNOSURE SHARMA 
Designation  PhD Scholar 
Affiliation  Sri Ramachandra Institute of Higher education 
Address  3rd floor, Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai
Faculty of Nursing, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai
Kancheepuram
TAMIL NADU
600125
India 
Phone  07010012763  
Fax    
Email  brahmacharimayumcynosuresharma@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, PORUR, CHENNAI, TAMIL NADU, INDIA. PIN CODE:600116 
 
Primary Sponsor  
Name  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCHFOUNDER CHANCELLOR RESEARCH FELLOWSHIP 
Address  Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra nagar, Porur, Kancheepuram District, Chennai, Tamil Nadu, India Pin code-600116 
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 Cynosure Sharma  SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH   Department of Nursing, pharmacy, physiotherapy, Allied health sciences and Dental college, Sri Ramachandra nagar, Porur, Chennai
Kancheepuram
TAMIL NADU 
7010012763

sharmacynosure3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers who are having high risk of developing metabolic syndrome 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gamification and social media-based lifestyle modification package  The intervention tool of the study will be Gamification and social media-based lifestyle modification Package (GSLMP) among the UG students with metabolic risk. It includes:  Knowledge: Information Education and Communication (IEC) on knowledge of metabolic syndrome will be provided for one month. 2 classes will be taken with the duration of 45 minutes each day at the end of every two weeks in a month. It will be delivered with the help of Computer Assisted Teaching, Flashcards, pamphlets, Ppt and videos in group wise manner of 20-25 participants at a specific classroom of the institution.  Lifestyle modification through gamification and social media -The participants in the intervention group will be provided a smartphone pedometer application which will count the steps taken and the participants have to strive the set step goals and accept the challenge given. The participants will be getting notifications daily on their progress. The step count should be increased gradually with the pattern of 50% and then 100% based on the WHO guidelines for at least 30 minutes moderate physical activity in a day to maintain a healthy life in the 1st and 3rd month. So, the participants will initiate with 15 minutes’ walk excluding the regular baseline count in the 1st month and then will shift to 30 minutes’ walk in the 3rd month which will then maintain the same till the end of 6th month. Regarding food activity, the participants should maintain the food dairy provided as per recommendations provided in the IEC and accept the challenge to upload pictures with geo tag of what they had in a day in social media by giving a catchy and inspirational caption under the #letsgamifit so that it can create awareness about healthy life to the social media users. Rewards: - Tangible rewards will be given based on certain criteria during the intervention 
Comparator Agent  Information Education and Communication on metabolic syndrome and health promoting behaviours with education booklet  The participants of control group will be receiving Information Education and Communication education (IEC) along with educational booklet on metabolic syndrome and health promoting behaviors by using Computer Assisted Teaching, Flashcards, pamphlets, Ppt and videos in a group wise manner of 20-25 participants at a specific classroom of the institution for a week with the duration of 30 minutes each. They will be encouraged to improve their physical activity and healthy dietary pattern based on the recommendations given. They will also be asked to use the pedometer smartphone application to track their step counts and maintain the food dairy provided but the gamification elements will not be provided such as rewards and challenges. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  The UG students who are
1. Willing to participate in the study and strictly adhere to all the stipulations of the intervention.
2. Able to meet any two or more components of screening criteria for metabolic syndrome given by IDF
3. Who has a smartphone

 
 
ExclusionCriteria 
Details  -known case of any CVD, diabetes mellitus, or any other chronic diseases
-using medication to treat any of the components of metabolic syndrome or on antidepressants, antipsychotics, or antithyroid drugs.
-contraindicated to the GSLMP due to chronic diseases.
-getting therapy or treatment that may interfere with test results.
-physically challenge
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
-Positive change in the physical activity, dietary habit, health promoting behaviours and metabolic syndrome risk among the UG students  3rd month and 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
 Improvement in the biophysiological and biochemical measures of UG students with metabolic syndrome risk.  3rd and 6th month 
 
Target Sample Size   Total Sample Size="206"
Sample Size from India="206" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/01/2025 
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   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 - Clinical Study Report

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

  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) - 

  6. For how long will this data be available start date provided 27-05-2027 and end date provided 27-09-2030?
    Response - Immediately following publication. No end date.

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

BACKGROUND

In 2019, NCDs accounts for 74% of deaths (nearly 42 million), out of which, India accounts for nearly 14.5% or nearly 4.1 million which contributes maximum proportion of deaths (66%), in the whole South-East Asian Region data of NCDs. The overall global prevalence estimated to be 20%–25% of the adult population. Most of the NCDs tends to increase as the age is advancing, so does metabolic syndrome. But surprisingly, the prevalence of metabolic syndrome has been evolving among the young adult age group as well in the recent past. In India, various studies have proven that prevalence of metabolic syndrome among adult is likely to be one by fourth of the total population. According to a study conducted by Manjunath et.al the prevalence of metabolic syndrome among young adult age group (18-25 years) is 8.7 % as per Indian Consensus Statement Criteria and 61.3% of the total population had one or more risk factors for metabolic syndrome in India.. Despite of knowing the fact that metabolic syndrome has been increasing among the young adults, very less studies have conducted among this age group especially in Tamil Nadu and Chennai is the most eligible urban area where numerous studies can be conducted to fulfil the need of epidemiological studies among the urban population as studies have shown higher prevalence in this population. Lifestyle modification is the main key steps to prevent or reverse the condition. In order to bring the lifestyle modification more easier for this particular age group, involvement of digital platform would be the most appropriate option. Gamification is one of the emerging method in digital health which has a great potential to influence the young adults in adopting lifestyle modifications. Additionally, social media is the most trending culture among this age group and will also have a huge impact on changing the lifestyle. Hence, finding out the prevalence of risk for metabolic syndrome among the young adult age group and providing gamification and social media based lifestyle modification intervention would be a beneficial step towards controlling and reversing the metabolic syndrome in our country.

PURPOSE

This research study is an experimental study which will be conducted among the UG students who belongs to 18-25 years of age. The purpose of the study is to find out the effectiveness of Gamification and Social media based Lifestyle Modification Package (GSLMP) on metabolic syndrome risk factors and health promoting behaviors among UG students with metabolic syndrome risk

 
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