Diabetes Mellitus, Type 2, Lifestyle Risk Reduction, Metabolic Syndrome
Conditions
Brief summary
Impact of lifestyle intervention in at-risk Asian Indians at worksite remains largely unexplored. The aim of this study was to assess impact of the multi-component interventions on body weight, body fat patterning and cardio-metabolic risk factors in overweight individuals working in corporate worksites in New Delhi, north India.
Detailed description
A randomized open label clinical trial is planned in 4 worksites. The total study duration is 18 months. Four workplace sites will be divided into two active intervention and two control sites. Intensive awareness generation activities for overweight and obese employees and a general awareness health, nutrition and physical education programme for the rest of the employees. The study subjects will be part of awareness sessions which will be conducted in the 6 month intervention period. Besides group sessions individual diet charts will also be worked out by a trained nutritionist. Physical activity advice will be provided to them keeping their specific requirements in mind. Pedometers will be provided to them and they will be encouraged to walk for 15 minutes in pre-lunch period. Leg movements at the desk will also be encouraged.
Interventions
BEHAVIORALLifestyle intervention
Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors
Sponsors
Sprim Advanced Life Sciences
Abbott
Diabetes Foundation, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years * Individuals who are willing to participate in the study
Exclusion criteria
* Previously diagnosed diabetics and patients with coronary artery disease. * Have received any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, (e.g. metformin, thiazolidinediones, steroids etc.) and on any medication that activate steroid and xenobiotic receptors * Pregnant and lactating women * Severe end organ damage or chronic diseases:renal/hepatic failure, any malignancy, major systemic illness etc. * Known case of HIV infection * Unwillingness to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with reduced Body Mass Index | 6 months | Body Mass Index measured in kg/m\^2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with reduced Fasting Blood Glucose | 6 months | Fasting Blood Glucose measured in mg/dl |
Outcome results
None listed