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CTRI Number  CTRI/2025/12/098669 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Screening 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of Community-Based Lifestyle Improvement Programme (CLIP) on Health Behaviours and Blood Glucose Control among Prediabetic Adults in Bengaluru 
Scientific Title of Study   Impact of Community based Lifestyle Improvement Programme (CLIP) on Healthy Behaviours, Glycemic control and Body metrices among prediabetic adults at selected community Bengaluru - A Quasi Experimental design 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kala suneetha 
Designation  Professor / Research Scholar 
Affiliation  sri Balaji Vidyapeeth University puducherry 
Address  Padmashree Institute of Nursing 146 padmashree campus kommaghatta sulikere post Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  07829616332  
Fax    
Email  suneemsc2009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Sumathy P 
Designation  Professor / Vice Principal 
Affiliation  sri Balaji Vidyapeeth University puducherry 
Address  sri Balaji Vidyapeeth University SBV Campus, Pillayarkuppam, Puducherry 607402
SBV Campus, Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY
560060
India 
Phone  9944759280  
Fax    
Email  sumathyp@kgnc.ac.in  
 
Details of Contact Person
Public Query  
Name  kala suneetha 
Designation  Professor / Research Scholar 
Affiliation  sri Balaji Vidyapeeth University puducherry 
Address  Padmashree Institute of Nursing 146 padmashree campus kommaghatta sulikere post Bangalore

Bangalore
KARNATAKA
560060
India 
Phone  07829616332  
Fax    
Email  suneemsc2009@gmail.com  
 
Source of Monetary or Material Support  
Self Funding 
 
Primary Sponsor  
Name  Kala Suneetha 
Address  Padmashree Institute of Nursing 146 padmashree campus Kommaghatta Sulikere Post Bangalore - 560060 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
kala suneetha  Primary Health Centre   Byrohalli Village, Sulikere Post Kengeri Bangalore
Bangalore
KARNATAKA 		 07829616332

suneemsc2009@gmail.com 
kala suneetha  Primary Health Centre  Sulikere Village Kengeri Bangalore
Bangalore
KARNATAKA 		 07829616332

suneemsc2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Padmashree Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Willing to Participate in the study 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community Life style Intervention  Education Session 45 Min Chair Pushup Exercises Yoga Mudra Distribution of Information booklet. later Reinforcement every month till 9th month. 
Comparator Agent  Control  Basic Education 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Between the age group of 30 – 60 yrs
Willing to participate in the study
who are residing in selected community of sulikere and Byrohalli
Able to write and read Kannada or English
 
 
ExclusionCriteria 
Details  Diagnosed with Diabetes mellitus
Critically ill, physically and mentally challenged
Diagnosed with other systemic diseases like HTN, CVD, Cancer, Renal diseases etc
Men and Women who are all under hormonal treatment
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Healthy Behaviour, FBS,HBA1c and Body Metrices
 		 3th Month; 6th Month; 9th Month
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   06/01/2026 
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="6"
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 - 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 - Informed Consent Form
    Response - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [suneemsc2009@gmail.com].

  6. For how long will this data be available start date provided 29-10-2027 and end date provided 29-05-2028?
    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 - NONE
Brief Summary  

This study aims to evaluate the effectiveness of a Community-based Lifestyle Improvement Programme (CLIP) on healthy behaviors, glycemic control, and body metrics among experimental and control groups, as well as to explore correlations and associations with demographic variables. The CLIP intervention includes structured education sessions, distribution of informational booklets, and a nine-month period of self-monitored physical activity and dietary modifications.

Key Objectives

  1. Effectiveness on Healthy Behaviors: Assess whether CLIP improves physical activity and dietary habits compared to controls.
  2. Effectiveness on Glycemic Control: Determine the impact of CLIP on glycemic markers (HbA1c, FBS) between groups.
  3. Effectiveness on Body Metrics: Evaluate changes in weight, height, BMI, waist circumference, and waist-hip ratio.
  4. Correlation Analysis: Examine the relationship between glycemic control and body metrics.
  5. Association with Demographics: Investigate how healthy behaviors, glycemic control, and body metrics relate to demographic factors.
 
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