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CTRI Number  CTRI/2024/10/074559 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Mobile based application]  
Study Design  Cluster Randomized Trial 
Public Title of Study   Improving Health with a Mobile Lifestyle Toolkit: A Study on Cardiometabolic Conditions 
Scientific Title of Study   Effectiveness of a mHealth-Based Lifestyle Toolkit on Health Outcomes among Individuals with Cardiometabolic Multimorbidity: A Type 1 Hybrid Effectiveness-Implementation Study 
Trial Acronym  MultiLife 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanveer Rehman  
Designation  Scientist B 
Affiliation  ICMR- Regional Medical Research Centre, Bhubaneswar 
Address  Room no.-43, Division-Public Health, Dept.-Public Health, ICMR- Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha-751023

Khordha
ORISSA
751023
India 
Phone  8336922482  
Fax    
Email  drtanveerrehman@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tanveer Rehman  
Designation  Scientist B 
Affiliation  ICMR- Regional Medical Research Centre, Bhubaneswar 
Address  Room no.-43, Division-Public Health, Dept.-Public Health, ICMR- Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha-751023

Khordha
ORISSA
751023
India 
Phone  8336922482  
Fax    
Email  drtanveerrehman@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tanveer Rehman  
Designation  Scientist B 
Affiliation  ICMR- Regional Medical Research Centre, Bhubaneswar 
Address  Room no.-43, Division-Public Health, Dept.-Public Health, ICMR- Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha-751023

Khordha
ORISSA
751023
India 
Phone  8336922482  
Fax    
Email  drtanveerrehman@gmail.com  
 
Source of Monetary or Material Support  
ICMR- Regional Medical Research Centre, Bhubaneswar 
 
Primary Sponsor  
Name  ICMR- Regional Medical Research Centre, Bhubaneswar 
Address  ICMR- Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha-751023 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tanveer Rehman  Model Rural Health Research Unit, Namkum  Model Rural Health Research Unit (MRHRU), Namkum, Ranchi, Jharkhand- 834010
Ranchi
JHARKHAND 		 8336922482

drtanveerrehman@gmail.com 
Tanveer Rehman  Model Rural Health Research Unit, Sheragada  Model Rural Health Research Unit (MRHRU), at Sheragada, Ganjam - 761106
Ganjam
ORISSA 		 8336922482

drtanveerrehman@gmail.com 
Tanveer Rehman  Model Rural Health Research Unit, Tigiria.  Model Rural Health Research Unit, ICMR- RMRCBB, Nizigarh Block, Tigiria, Odisha 754030
Cuttack
ORISSA 		 8336922482

drtanveerrehman@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ICMR- REGIONAL MEDICAL RESEARCH CENTRE, BHUBANESWAR, INSTITUTIONAL HUMAN ETHICS COMMITTEE  Approved 
Institutional Ethics Committee, RIMS, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of Care  Participants will receive standard care provided by healthcare facilities, serving as a reference group for evaluating the effectiveness of the MultiLife intervention. 
Intervention  The MultiLife intervention (mHealth-based multicomponent lifestyle toolkit tailored for individuals with cardio-metabolic multimorbidity)   Intervention will span for six months and be delivered via smartphone, focusing on dietary guidance, physical activity promotion, tobacco/alcohol cessation support, and medication adherence strategies. Components of MultiLife: 1. Mobile App Installation 2. Daily Reminders and Alarms: The participants will receive daily one time app reminders and alarms from the application to support behavior change. 3. Health Education (HE) Broadcast: HE videos will be broadcasted by the app to all users twice monthly for first three months and once a month for subsequent three months, totaling nine videos. In this each session will be approximately 10 minutes long with audio and subtitles in the local language. The detailed frequency and content of the session is as follows: [1] Introductory education session on Diabetes Mellitus, Hypertension, Coronary Artery Disease and Stroke: Session 1 and 9 [2] Adherence to medications: Session 2 and 8 [3] Physical activity and stress management: Session 3 and 7 [4] Diet and nutrition: Session 4 and 6 [5] Tobacco and alcohol cessation: Session 5 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Individuals diagnosed with CMM
2. Aged 18 to 70 years, providing informed consent for participation and expressing
willingness to comply with follow-up requirements
3. Own an Android mobile phone. 
 
ExclusionCriteria 
Details  Patients with cognitive impairment hindering instruction-following,
bedridden status, severe mental illness, ongoing cancer treatment, or those in end-of-life care,
pregnancy, or individuals not planning to reside in the study area during the intervention period. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is the clinical effectiveness of MultiLife, shown by the change in HbA1c from baseline to six months post-intervention, with a clinically significant reduction defined as 0.5 percentage points or greater. HbA1c levels will be measured at baseline, three months, and six months.  Baseline (at zero month), three months, and six months. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcomes: Change in systolic and diastolic blood pressure, BMI & WC, QoL scores, dietary
patterns, tobacco and alcohol consumption, adherence to prescribed medications, level of physical activity. 		 BP(systolic and diastolic)- Baseline, Three months, Six months.
BMI & WC-Baseline, Three months, Six months.
QoL scores- Baseline and Six months.
Dietary patterns -Baseline, and six months.
Tobacco and alcohol consumption-Baseline and Six months.
Adherence to prescribed medications-Baseline and Six months.
Level of physical activity-Baseline and Six months. 
 
Target Sample Size   Total Sample Size="840"
Sample Size from India="840" 
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)   01/12/2024 
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 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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

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

  5. By what mechanism will data be made available?
    Response (Others) -  We will provide the dataset to individuals through the email i d

  6. For how long will this data be available start date provided 23-12-2026 and end date provided 23-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study evaluates the effectiveness of a lifestyle toolkit delivered via mHealth channels by primary health care staff in reducing HbA1c levels, BP, and BMI among individuals with cardiometabolic multimorbidity (CMM) in India. Using a two-arm parallel group 1:1 cluster randomized controlled trial design, the intervention group receives (a digital platform, ASHA/ PHC support, and usual care) against the control group (ASHA/ PHC support and usual care). Conducted over 24 months across three cohorts in states Jharkhand( MRHRU, Namkum ) and Odisha (MRHRU, Tigiria and MRHRU, Sheragada), the "MultiLife" intervention includes a mobile app providing daily reminders for lifestyle modifications and monthly health education videos. Primary outcome measures include changes in Glycemic control, with secondary outcomes encompassing Blood Pressure(systolic and diastolic), Body mass index and Waist circumference, Quality of life, stress levels, substance usage ( tobacco & alcohol usage), adherence to drugs and physical activities. This study aims to leverage community resources and technology to reduce the CMM burden in India, potentially informing public health strategy. 
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