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A virtual assistance based lifestyle intervention in young employees of Information Technology industry in India: LIMIT (LIfestyle Modification in IT)


Funded By: Diabetes Unit, King Edward Memorial Hospital Research Center (KEMHRC), Pune, India and Department of Science & Technology (DST), Government of India, New Delhi, India
 
Month & Year of Commencement:  May 2012
Period of Study:  3 years
Current Status:  Completed

Principal Investigator: Dr. C.S.Yajnik, Director,Diabetes Unit, KEM Hospital and Research Centre,Pune,India
Co-Investigator: Tejas Limaye, Diabetes Unit, KEM Hospital and Research Centre, Pune, India.


STUDY DETAILS

Type of Trial:  Interventional

Study Design:  Randomized, Parallel Group Trial

Scientific Title of Study: A study to determine the effect of a lifestyle modification programme on preventing or delaying the onset of type 2 diabetes mellitus in pre-diabetic individuals in IT industry.

Public Title of Study: A study to determine the effect of a lifestyle modification programme on modifiable risk factors for type 2 diabetes mellitus in high risk individuals in information technology (IT) industry.

Acronym: LIMIT (LIfestyle Modification in IT)

Contact Person:

Scientific Query:

  • Name Prof Chittaranjan S Yajnik
  • Designation:  Director
  • Affiliation:  Diabetes unit, King Edward Memorial Hospital Research Center
  • Address:  6th Floor, Banoo Coyaji Building, King Edward Memorial Hospital Research Center (KEMHRC), Sardar Moodliyar Road, Rasta Peth Pune - 411011
  • Phone:  02026111958 Fax 02026111958
  • Email: diabetes@kemdiabetes.org

Public Query:

  • Name: Ms Tejas Y Limaye
  • Designation: Research Fellow
  • Affiliation:  Diabetes unit, King Edward Memorial Hospital Research Center
  • Address: 6th Floor, Banoo Coyaji Building, King Edward Memorial Hospital Research Center (KEMHRC), Sardar Moodliyar Road, Rasta Peth Pune - 411011
  • Phone:  02026111958 Fax 02026111958
  • Email: diabetes@kemdiabetes.org

Countries of Recruitment: India

Details of Ethics Committee:

Name of EC Committee: KEM Hospital Research Centre Ethics Committee, Pune

Approval Status: Approved

Date of Approval: 11/04/2011

Participants: Healthy Human Volunteers

Health Condition / Problems Studied: Type 2 diabetes mellitus and metabolic syndrome


Intervention / Comparator Agent:

Intervention:  Conventional lifestyle advice at baseline (group session, informative leaflets) Plus Intensive lifestyle advice through virtual assistance:
  1. Informative e-mails: twice a week
  2. Mobile messages: three times a week
  3. Website support for tracking progress
  4. Facebook page updates for reinforcement
  5. Every 3 months voice contact to remind on follow-up date

Comparator Agent : Standard lifestyle advice

  1. Conventional lifestyle advice at baseline (group session, informative leaflets)
  2. Every 3 months voice contact to remind on follow up date

Inclusion Criteria

Age: From 18.00 years to 70.00 years Gender: Both

Details

  • IT industry employees with three or more of the following eight risk factors:
  1. Family history of type 2 diabetes or cardiovascular disease
  2. Overweight or obesity (Body mass index ≥25kg/m2)
  3. Central obesity (waist circumference ≥90cm in men, ≥80cm in women)
  4. High triglyceride levels (≥150 mg/dL)
  5. Low HDL cholesterol (<40 mg/dL in men / <50 mg/dL in women)
  6. High LDL cholesterol (≥130 mg/dL)
  7. Raised blood pressure (systolic BP ≥130 or diastolic BP ≥ 85mm Hg)
  8. Impaired fasting glucose (≥100 mg/dL)
  • Individuals who are likely to stay in Pune for 12 months and willing to consent
  • Individuals possessing mobile phones, with the ability to read, reply & comprehend the messages in English.

Exclusion Criteria    

  • Individuals with known diabetes, hypertension or dyslipidemia (on treatment)
  • Individuals with other chronic illnesses or metabolic disorders needing treatment
  • Individuals with limitations on physical activity
  • Individuals not willing to participate or consent
  • Individuals not possessing mobile phones or unable to read, reply & comprehend the messages in English

Method of Generating Random Sequence: Computer generated randomization

Method of Concealment: On-site computer system

Blinding/Masking: Open Label (laboratory technicians and statisticians blinded)

Primary Outcome: Change in prevalence of overweight-obesity

Secondary Outcome:

Change in anthropometric and metabolic risk factors (weight, waist circumference, body composition, blood pressure, biochemical parameters – fasting plasma glucose, triglycerides, HDL cholesterol, LDL cholesterol etc.)

Follow-up

3, 6, 9 months (every quarter during intervention) - Anthropometric parameters and blood pressure

12 months (Post intervention)- All parameters including biochemical parameters

Target Sample Size: 264 (132 per group)

Pre-trial analysis (October 2011) of annual health records of IT employees from 2 IT industries in Pune showed a prevalence of 75% overweight-obesity in high-risk group. We set out to detect a difference of 25% in the prevalence of overweight-obesity between the intervention and the control groups (1:1) at 1 year at 5% significance and 80% power. A dropout of 25% was assumed due to high attrition rates and frequent travel schedules in IT professionals. This gave us the required sample size of 132 individuals in each group.

Date of First Enrollment: May 2012  

Estimated Duration of Trial: 3 years

Recruitment Status of Trial: Completed

Publication Details: Will be published as an original paper after completion

Brief Summary: This study is a randomized parallel group trial assessing the effectiveness of a lifestyle modification program (through virtual assistance) on modifiable risk factors for type 2 diabetes mellitus. We chose IT industry employees as our target population as this group has seen the maximum impact of the economic growth in India and also has sedentary work style, long working hours, erratic eating habits and high stress levels. We studied prevalence of risk factors for type 2 diabetes mellitus and launched a lifestyle modification program through virtual assistance. The participants were screened using a structured questionnaire, anthropometric measurements, blood pressure and fasting blood tests for glucose and lipids. High risk participants were individually randomized into control and intervention groups. Both groups received lifestyle advice at baseline while the intervention group continued to receive reinforcement on diet, exercise, weight and stress management through mobile messages (three times a week), emails (twice a week), website support and face book page updates for one year. Both groups were followed up every three months for anthropometry and blood pressure. Fasting blood tests were repeated at 12 months (1 year) of intervention.

Study Status: The intervention is completed; lab measurements and data analysis completed.

Expected outcomes: This study will throw light on effectiveness of an intervention through virtual assistance on lifestyle choices and modifiable risk factors for type 2 diabetes mellitus. With the IT sector continuing to grow in India, raising awareness and designing behaviour related interventions in the workplace may be an effective public health measure.




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