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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:
- Informative e-mails: twice a week
- Mobile messages: three times a week
- Website support for tracking progress
- Facebook page updates for reinforcement
- Every 3 months voice contact to remind on follow-up date
Comparator
Agent :
Standard lifestyle advice
- Conventional lifestyle advice at
baseline (group session, informative
leaflets)
- 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:
- Family history of type 2 diabetes or
cardiovascular disease
- Overweight or obesity (Body mass index
≥25kg/m2)
- Central obesity (waist circumference
≥90cm in men, ≥80cm in women)
- High triglyceride levels (≥150 mg/dL)
- Low HDL cholesterol (<40 mg/dL in
men / <50 mg/dL in women)
- High LDL cholesterol (≥130 mg/dL)
- Raised blood pressure (systolic BP
≥130 or diastolic BP ≥ 85mm Hg)
- 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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