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CTRI Number  CTRI/2025/09/095092 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Measuring Mental Wellbeing and Resilience in Type 2 diabetes mellitus patients MERIT-2-DM 
Scientific Title of Study   Effectiveness of peer-group, buddy-paired, and individual diabetes care models for promoting Mental well-being and Resilience in adults with Type 2 Diabetes mellitus from rural central India (MERIT-2 DM): a three-arm parallel cluster randomized controlled trial. 
Trial Acronym  MERIT-2 DM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SREERAM B 
Designation  JUNIOR RESIDENT 
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES 
Address  Room number 5, Dr.Sushila Nayar School of Public health(incorporating the Department of Community Medicine)old hospital building, bapu kuti road, Mahatma Gandhi Institute of Medical Sciences(MGIMS), Sevagram, Wardha, Maharashtra. 442102

Wardha
MAHARASHTRA
442102
India 
Phone  8056849969  
Fax    
Email  doctorsrofficial@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ABHISHEK V RAUT 
Designation  ASSISTANT PROFESSOR 
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES 
Address  Room number 5, Dr.Sushila Nayar School of Public health(incorporating the Department of Community Medicine)old hospital building, bapu kuti road, Mahatma Gandhi Institute of Medical Sciences(MGIMS),Sevagram, Wardha, Maharashtra. 442102

Wardha
MAHARASHTRA
442102
India 
Phone  9422518347  
Fax    
Email  abhishekvraut@gmail.com  
 
Details of Contact Person
Public Query  
Name  SREERAM B 
Designation  JUNIOR RESIDENT 
Affiliation  MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES 
Address  Room number 5,Dr.Sushila Nayar School of Public health(incorporating the Department of Community Medicine)old hospital building, bapu kuti road, Mahatma Gandhi Institute of Medical Sciences(MGIMS),Sevagram, Wardha, Maharashtra. 442102

Wardha
MAHARASHTRA
442102
India 
Phone  8056849969  
Fax    
Email  doctorsrofficial@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Institute of Medical Sciences,Sewagram,Wardha,Maharashtra,India. 442102 
 
Primary Sponsor  
Name  Mahatma Gandhi Institute of Medical Sciences 
Address  Dr.Sushila Nayar School of Public health(incorporating the Department of Community Medicine)old hospital building, bapu kuti road, Mahatma Gandhi Institute of Medical Sciences(MGIMS),Sevagram, Wardha, Maharashtra. 442102 
Type of Sponsor  Other [Government aided Medical College 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 
SREERAM B  Mahatma Gandhi Institute of Medical Sciences  Room number 5, Dr.Sushila Nayar School of Public health(incorporating the Department of Community Medicine)old hospital building, bapu kuti road, Mahatma Gandhi Institute of Medical Sciences(MGIMS),Sevagram, Wardha, Maharashtra. 442102
Wardha
MAHARASHTRA 		 8056849969

doctorsrofficial@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diabetes care package given through peer-group. buddy pairing and individual arms.  As this study compares effectiveness, each arm will act as a comparator for others thereby serving as both intervention and control for the study related outcomes. 
Intervention  Diabetes care package given through peer-group. buddy pairing and individual arms.  The diabetes care package will be developed in coordination with stakeholders and primary health care team. As this study compares effectiveness, each arm will act as a comparator for others thereby serving as both intervention and control for the study related outcomes. A. Arm 1 . Peer group support: Participants will be organized into peer groups of 3 to 6 members to support each other to practice the co-designed diabetes care package. B. Arm-2: Buddy pairing: Participants will be grouped into buddy pairs that is 2 members in each group to support each other to practice the co-designed diabetes care package. C. Arm-3: Individual care: Participants will receive individual-level care as per the co-designed intervention package and will self-support to practice the co-designed diabetes care package. The co-designed diabetes care package would focus on interventions for enhancing mental well being. interpersonal relationship. skill building. coping strategies. physical activity. mindfulness. managing diabetes and diet and nutrition and so on. The interventions will be implemented through trained primary health care team once a month for a cumulative duration of 40 to 60 minutes every month for 6 consecutive months. The interventions will be delivered to all the participating patients in the study and they will be expected to practice individually and support each other either through peer groups or buddy pairing or self-support depending on the arm of the study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA FOR CLUSTERS
Villages under PHCs with no vacancy in primary health care staff namely CHO NCD ANM and ASHA under NP NCD program with good network connectivity will be selected
A radius of 30 km is being kept for including villages under the field practice area.

INCLUSION CRITERIA FOR INDIVIDUALS/PARTICIPANTS

Providing written informed consent
Know diabetic resident of the same village for over 6 months
Willing to comply with the intervention activities and study procedures
Willing to stay in study area for the entire study duration

 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA FOR CLUSTERS
NP NCD staff under the concerned health and wellness centre not consenting to support the study

Villages lacking adequate

EXCLUSION CRITERIA FOR INDIVIDUALS/PARTICIPANTS

Patients under 18 years of age
Those who will be categorized under severe score that is score of 9 to 13 during the initial screening using PHQ 4 questionnaire

Patients with complication in chronic conditions such as cardiovascular issues chronic kidney disease stroke and so on
Patients who are already on psychiatric treatment
Pregnant and Lactating females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Mental well-being
2) Resilience  		 1)Baseline and post 6 months of intervention.
2)Baseline and post 6 months of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Diabetes related quality of life will be assessed with "Diabetes Quality of life Brief Clinical Inventory a 15 item inventory.  Baseline data will be collected using the above mentioned questionnaires during the initial Implementation phase after taking informed consent.

Endline assessment will be done in the Post implementation phase using the same scales as mentioned priorly. 
Control of Diabetes measured through HbA1c levels from early morning blood sample under standardized quality-controlled procedures following aseptic precautions.  Baseline value will be collected during the Implementation phase before starting the intervention.
Endline values will be collected in post-implementation phase. 
Factors determining acceptability and practice of Diabetic care package interventions will be analyzed using PARIHS(Promoting Action on Research Implementation in Health Services) framework.  Post implementation phase. 
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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)   02/10/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  
The MERIT-2 DM study is a cluster-randomized controlled trial aimed at evaluating the effectiveness of three models of diabetes care: peer-group support, buddy pairing, and individual care-in improving mental well-being, resilience, quality of life, and diabetes control among adults with Type 2 Diabetes Mellitus (T2DM) and acceptability and practice such models  in rural central India. With the rising diabetes in India, particularly in underserved areas, and the psychological impact of the disease, this study integrates psychosocial interventions into diabetes management.

A total of 192 participants from 24 rural clusters (villages) across three Ayushman Arogya Mandir Primary Health Centers will be enrolled. Participants will be randomized into one of three arms: (1) peer-group support, (2) buddy-pairing, or (3) individual standard care. Over a 6-month intervention period, trained health workers will deliver structured diabetes care sessions focusing on mental well-being, lifestyle changes, interpersonal skills, and self-management. These sessions will be followed by another 6 months of follow-up and evaluation.

Primary outcomes include improvements in mental well-being (measured using WHO-5) and resilience (measured by the Brief Resilience Scale). Secondary outcomes include changes in diabetes-related quality of life, HbA1c levels, and acceptability of the intervention models. Both quantitative (via validated scales and blood tests) and qualitative methods (via interviews and thematic analysis) will be used to assess impact.

As the study is trying to assess the effectiveness of the different methods of diabetes care delivery such as  peer groups, buddy pairs, and individual level each arm will serve as both intervention and control arm and hence blinding will not be possible for this study.

This study addresses a critical gap in India’s NP-NCD program, which currently lacks mental health integration in diabetes care. If successful, the MERIT-2 DM model could serve as a cost-effective, scalable, and culturally relevant strategy to improve psychosocial and clinical outcomes among rural diabetic populations, potentially informing national policy and strengthening community-based chronic disease care. Approval from ethics committee was obtained and  currently submission of approved documents and title and synopsis of the thesis is under process  to the the concerned university. Once the university shows no objection to proceed I the principal investigator will begin with the study in a phased manner, such as preparatory phase, implementation phase and post implementation phase. 
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