Clinical trial NCT03249610: Randomized Control Trial for Overweight Employees in Worksites
Official title: Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Metabolic Syndrome
Lifestyle Risk Reduction
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
Collaborators: name: Sprim Advanced Life Sciences
name: Abbott
First posted: 2017-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with reduced Body Mass Index
timeFrame: 6 months
Secondary outcomes:
measure: Number of subjects with reduced Fasting Blood Glucose
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Diabetes Foundation, India
name: Dr. Anoop Misra
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shrivastava U, Fatma M, Mohan S, Singh P, Misra A. Randomized Control Trial for Reduction of Body Weight, Body Fat Patterning, and Cardiometabolic Risk Factors in Overweight Worksite Employees in Delhi, India. J Diabetes Res. 2017;2017:7254174. doi: 10.1155/2017/7254174. Epub 2017 Nov 29.