| 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
|
|
|
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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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. |
|
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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
|
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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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 |
|
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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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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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 |