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CTRI Number  CTRI/2017/09/009710 [Registered on: 11/09/2017] Trial Registered Retrospectively
Last Modified On: 11/09/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening 
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness of mobile health (mHealth) intervention programme (mHealth-MS) on Metabolic Syndrome 
Scientific Title of Study   Epidemiological study of Metabolic Syndrome in Rural Population of Rajasthan & Effectiveness of mHealth intervention programme (mHealth-MS) on its components: A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arvind Kumar 
Designation  Assistant Professor 
Affiliation   
Address  Dept, of PSM, RUHS College of Medical Sciences, Sector 11, Kumbha marg, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302015
India 
Phone  8559814816  
Fax    
Email  dranuaiims@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Arvind Kumar 
Designation  Assistant Professor 
Affiliation  RUHS 
Address  dept. of PSM, RUHS College of Medical Sciences, sector 11, Kumbha Marg, Tonk Road Jaipur
Rajasthan University of Health Sciences, sector 18, Kumbha Marg, Tonk Road Jaipur
Jaipur
RAJASTHAN
302033
India 
Phone  8559814816  
Fax    
Email  dranuaiims@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Arvind Kumar 
Designation  Assistant Professor 
Affiliation  RUHS 
Address  dept. of PSM, RUHS College of Medical Sciences, sector 11, Kumbha Marg, Tonk Road Jaipur
Rajasthan University Of Health sciences, sector 18, Kumbha Marg, Tonk Road Jaipur
Jaipur
RAJASTHAN
302033
India 
Phone  8559814816  
Fax    
Email  dranuaiims@yahoo.com  
 
Source of Monetary or Material Support  
Rajasthan University of Health Sciences,RUHS College of Medical Sciences, sector 18, Kumbha Marg, Tonk Phatak Jaipur  
 
Primary Sponsor  
Name  Rajasthan University of Health Sciences 
Address  RUHS College of Medical Sciences, Sector 18, Pratap Nagar, Kumbha Marg, Sanganer,Sector 18, Pratap Nagar, Kumbha Marg, Sanganer, Jaipur 
Type of Sponsor  Government funding agency 
 
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 Arvind Sharma  RUHS College of Medical Sciences, Jaipur  dept. of PSM, RUHS College of Medical Sciences, sector 11, Kumbha Marg, Tonk Phatak Jaipur
Jaipur
RAJASTHAN 
8559814816
8559814816
dranuaiims@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RUHS college of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy, prediabetics, Diabetics, Prehypertensive, Hypertensive, obase  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  mhealth Intervention  • Unidirectional daily IVRS audio clip will be used to deliver health messages and triggers to promote knowledge, healthy eating, exercise, self-efficacy, and medication adherence. In this study, subjects will receive two IVRS audio clip daily (7 a.m. and 8 p.m.) on their mobile phone for 1 year. IVRS will be delivered by a fully automated system.  
Comparator Agent  standard care  •standard care  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. all individual greater than or equal to twenty years of age
2. have metabolic syndrome
3. Has a text message–capable mobile phone
4. Know how to receive IVRS audio messages
5. Speak and read Hindi.
 
 
ExclusionCriteria 
Details  1. individual below 20 years of age
2. pregnant women
3. overt psychosis,
4. those participants who are not willing or in position to give consent due to any reason
5. Individuals with a previous physician diagnosis of hypertension or diabetes mellitus, who had not reported medication use
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Disease progression
2. Knowledge about Diabetes, Hypertension, Obesity, Hypercholestromia 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
ï‚§ Quality of Life (EQ-5D questionnaire)
ï‚§ Cost effectiveness of IVRS interventions  
1 year 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "1000"
Final Enrollment numbers achieved (India)="1000" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/11/2016 
Date of Study Completion (India) 20/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Intensive programs like lifestyle modifications, drug adherence, exercise, etc. through mobile phone messages to effect significantly reduce or delay the onset of MS. mHealth refers to the utilization of mobile phones and other personal mobile devices as a platform for public health or medical interventions. The present study will be undertaken with the objectives to study the prevalence of MS and to assess the effect of mHealth-MS intervention programme on its selected components in rural population of Rajasthan. A community based intervention study including 4000 subjects’ age 20 years & above will be selected using multi stage cluster sampling method & PRePAre risk assessment study’s questionnaire was used to study risk factors. Each cluster would be 100 participants from each primary sampling unit (PSUs) and total no. of required clusters are 40. In this study comparing [1] standard of care (50% clusters) with standard of care plus a mobile phone based IVRS intervention [50% clusters] for 1 year among patients with MS. IVRS audio messages will be delivered health messages and triggers to promote knowledge, healthy eating, exercise, self-efficacy, and medication adherence for one year. After the development of tools and strategy and assessing the success of this intervention (midterm), research cum action projects will be developed for other regions of the Rajasthan.

 
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