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CTRI Number  CTRI/2026/01/100513 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [interventions for diet modifications ]  
Study Design  Single Arm Study 
Public Title of Study   Healthy Eating and Active Living Program  
Scientific Title of Study   Development and Implementation of workplace-based lifestyle program for reducing the risk of Diabetes in employees 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rekha Rachel Philip 
Designation  Assistant Professor 
Affiliation  Government Medical College Kollam 
Address  Department of Community Medicine, Govt. Medical College Kollam, Parippally, Kerala

Kollam
KERALA
691574
India 
Phone  09447304155  
Fax    
Email  rekharachel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rekha Rachel Philip 
Designation  Assistant Professor 
Affiliation  Government Medical College Kollam 
Address  Department of Community Medicine, Govt. Medical College Kollam, Parippally, Kerala

Kollam
KERALA
691574
India 
Phone  09447304155  
Fax    
Email  rekharachel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rekha Rachel Philip 
Designation  Assistant Professor 
Affiliation  Government Medical College Kollam 
Address  Department of Community Medicine, Govt. Medical College Kollam, Parippally, Kerala

Kollam
KERALA
691574
India 
Phone  09447304155  
Fax    
Email  rekharachel@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College Kollam ,Kerala 
 
Primary Sponsor  
Name  Rekha Rachel Philip 
Address  Dept.of Community Medicine government Medical College Kollam Kerala 
Type of Sponsor  Other [Self ] 
 
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 
Rekha Rachel Philip  Offices of Kerala state electricity board   KSEB Office, Kollam
Kollam
KERALA 		 09447304155

rekharachel@gmail.com 
Rekha Rachel Philip  Vydyuti Bhavan  Vydyuti Bhavan Pattom Thiruvananthapuram
Thiruvananthapuram
KERALA 		 09447304155

rekharachel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Human Ethics Committee Government Medical College Kollam  Approved 
Human Ethics Committee Government Medical College Kollam  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Employees with high risk of diabetes  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  comparator  Not applicable 
Intervention  Intervention packages for reducing risk of diabetes in workplace  1.Risk communication- during recruitment the participants will be given a face to face counselling regarding their risk for developing Type 2 Diabetes. This communication is supposed to motivate the participants to achieve the risk reduction goals 2.Goal-based behavioural intervention weight loss goal- Participants are encouraged to achieve the 7% weight loss in the first 6 months of the lifestyle intervention, since previous behavioral weight loss studies have suggested that most individuals achieve their maximum weight loss within the first 20–24 weeks of a lifestyle intervention (17). The recommended pace of weight loss is 0.5-1 kg per week. Participants who wish to lose 7% of their baseline weight are encouraged to do so, as long as they continued to have a BMI of 21 kg/m2. waist circumference loss goal Physical activity goal- 150 min of moderate physical activities similar in intensity to brisk walking. This goal is similar to the WHO and NIN recommendations Food plate goal HbA1C reduction goal 3.Peer influencers:one professional health educator and identify two-three lay educators from among the staff at the site.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Employees of Kerala State Electricity Board with indian diabetic risk score of 30 or above 
 
ExclusionCriteria 
Details  1.Body Mass Index Less than 23 and or
2.waist circumference less than 90cm for men and <80 cm for women.
3.Those with self reported Renal,Cardiac diseases
4.Those with definite plans of migration in next one year
Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Program adoption -Proportion of employees adopting the intervention package (assumed as 60%)
2.Reach of the Programme-Proportion of employees exposed to the intervention programme 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Program adoption by participants at 6 months 2.Reach of the programme among the participants at 6 months
3Program effectiveness by evaluating the change in proportion of individuals reaching two or more diabetic risk goals namely reduction in waist circumference(more than or to 5cm), weight reduction more than7% baseline, systolic blood pressure decrease more than or equal to 5mmHg & HbA1C decrease more than or equal to 0.5%, after 3 & 6 months of intervention 		 1.Adoption & reach at 6 months
2.Effectiveness at 3 months & 6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   19/01/2026 
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="3"
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 - 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
    Response -  Analytic Code

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 10-01-2026 and end date provided 26-12-2055?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - only de-identified data will be shared
Brief Summary   We plan to develop an implementation model delivering lifestyle intervention (Diet and physical activity) for 80% coverage of employees in selected KSEB offices of Kollam and Vydyuti Bhavan and to measure the success of implementation of this intervention program by evaluating program adoption, fidelity to the program ,acceptability and effectiveness of the program

 and to determine  the effectiveness of the program among participants  by evaluating the change in proportion of individuals at high risk of developing diabetes  reaching two or more diabetes risk reduction goals namely reduction in waist circumference,  weight , Blood pressure and HbA1C.Our sample size is 400 with outcomes being evaluated at 3 months and 6 months.The intervention will be developed in the first phase of the study through qualitative methods.The intervention components will be risk communication, goal based intervention for weight loss, physical activity and food plate delivered through peer influencers in 16 sessions of 30 minutes each

 
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