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CTRI Number  CTRI/2021/07/035289 [Registered on: 30/07/2021] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   A study to evaluate the effectiveness of a community based intense lifestyle intervention program to facilitate the conversion of dysglycemia (abnormal glucose level) to normoglycemia (normal glucose level)  
Scientific Title of Study   Randomized controlled trial to evaluate the effectiveness of a community based intense lifestyle intervention program to facilitate the regression to normoglycemia among women with isolated impaired fasting glucose in Kasaragod district, Kerala, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Elezebeth Mathews 
Designation  Assistant Professor 
Affiliation  Central University of Kerala 
Address  Brahmaputra, Central University of Kerala Periye
Periya
Kasaragod
KERALA
671316
India 
Phone  9495221707  
Fax    
Email  elezebethmathews@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Elezebeth Mathews 
Designation  Assistant Professor 
Affiliation  Central University of Kerala 
Address  Brahmaputra, Central University of Kerala Periye
Periya
Kasaragod
KERALA
671316
India 
Phone  9495221707  
Fax    
Email  elezebethmathews@gmail.com  
 
Details of Contact Person
Public Query  
Name  Elezebeth Mathews 
Designation  Assistant Professor 
Affiliation  Central University of Kerala 
Address  Brahmaputra, Central University of Kerala Periye
Periya
Kasaragod
KERALA
671316
India 
Phone  9495221707  
Fax    
Email  elezebethmathews@gmail.com  
 
Source of Monetary or Material Support  
Wellcome Trust DBT India Alliance 
 
Primary Sponsor  
Name  Wellcome Trust DBT India Alliance 
Address  2nd Floor, Nishant House, 8-2-351/N/1, Rd Number 2, Venkateshwara Hills, Banjara Hills, Hyderabad, Telangana 500034 
Type of Sponsor  Other [Funded by Department of Biotechnology, Government of India and the Wellcome Trust, UK] 
 
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 Elezebeth Mathews  Central University of Kerala  Department of Public Health and Community Medicine, Central University of Kerala, Kasaragod district Kerala
Kasaragod
KERALA 		 9495221707

elezebethmathews@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee Central University of Kerala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prediabetes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community based intense Lifestyle interventions  Intervention includes monthly session with group based sessions and individual based sessions for a period of 12 months. Group based sessions will be delivered the project team and peer mentors. Peer mentor will be identified from within each cluster in the intervention arm. Peer mentors will undergo 5 days capacity building training program to guide and assist the participants in making lifestyle modification with the support of the extended community stakeholders. Context-culture specific resource materials for participant and peer mentor will be developed. Apart from regular group and individual sessions, the first twelve months will also include activities that facilitate diabetes prevention such as kitchen garden training, yoga, walking groups and healthy cooking workshops that involve family members as well. There will be no active engagement of the project team during 13-24 months, to see the self-sustainability of the activities.  
Comparator Agent  Health education  Health Education will be given to the control arm. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  (I) Inclusion criteria for screening (stage 1):

1) Women aged 30-60 years, 2) able to read, write and speak Malayalam, the local language 3) consents to participate in the study, 4) not a known diabetic, 5) no prior history of GDM



(II) Inclusion criteria for the trial (stage 4):
Participants should satisfy all the inclusion criteria for screening and should be diagnosed with isolated impaired fasting glucose in OGTT.
 
 
ExclusionCriteria 
Details  (i) Exclusion criteria for screening:
-Women with T2DM, diabetes in pregnancy
-With prior history of GDM, having chronic illnesses/ disease conditions or on medications that alter glucose metabolism will be excluded. Women with mental illness based on ICD-10 classification44 will also be excluded

(ii) Exclusion criteria for the trial: all exclusion criteria for screening and also the newly diagnosed with diabetes or diabetes in pregnancy will be excluded. A screening questionnaire will be used to ensure that participants meet the inclusion and exclusion criteria.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of regression from iIFG to normoglycemia at 24 months   Incidence of regression from iIFG to normoglycemia at 24 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. Glycemic level assessment
2. Lipid profile assessment
3. Blood pressure monitoring
4. Anthropometric assessments
5. Behavioral risk factor assessment
6. Psychosocial assessment
7. Other clinical assessments such as fat percentage and muscle mass 		 Assessments will be made at 24 months 
 
Target Sample Size   Total Sample Size="448"
Sample Size from India="448" 
Final Enrollment numbers achieved (Total)= "1092"
Final Enrollment numbers achieved (India)="1092" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) 31/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

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

  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) -  Data associated with each publication will be available in an OSF platform

  6. For how long will this data be available start date provided 09-10-2022 and end date provided 09-11-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  

India has the second-largest number of people (77 million) living with T2DM, next only to China, with at least as many more undiagnosed. Kerala, the southernmost State of India is the most advanced state in epidemiological transition with the highest prevalence of T2DM (nearly 20 %) and its risk factors in the country. High prevalence rates of overweight (nearly half) and physical inactivity among women in Kerala pose a continuing threat to the T2DM burden. Most landmark lifestyle modification trials were done on individuals with impaired glucose tolerance (IGT)   as it is a better predictor of micro-vascular complications and metabolic syndrome and is a strong predictor of cardiovascular complications. However, the annual risk to the progression of T2DM is over 5 times for individuals with isolated impaired glucose tolerance (iIGT), 7 times for isolated impaired fasting glucose (iIFG) and over 12 times for those with both IFG and IGT when compared to normoglycemic individuals. Till date, only three large trials, one in Japan and two in India were conducted to prevent T2DM among individuals with iIFG.  However, all the three trials targeted individuals across pre-diabetes spectrum and found lower risk reduction among the iIFG group when compared to iIGT and IGT+IFG group. Lack of evidence on positive effects of lifestyle modification in the iIFG group among Asian Indians warrant further exploration on strategies to reduce the incidence of T2DM as individuals with isolated impaired fasting glucose constitute a major group (57.5%)  in the pre-diabetes spectrum among Indians. Furthermore, it is vital to see the effect of intense lifestyle modification intervention across the IFG spectrum in a representative sample of individuals with IFG. Early regression to normoglcemia in people with impaired glucose regulation is associated with reduction in T2DM and no trials have shown such effects in those with i-IFG.

This study aims to assess the effectiveness of a community based intense lifestyle modification program among women with isolated impaired fasting glucose in regression from dysglycemic state (iIFG) to normoglycemia. Collectivistic family centered decision making over individualistic in Kerala emphasizes the importance of peer support, family involvement and community engagement for a sustained behaviour change.


 
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