Randomized Control Trial for Overweight Employees in Worksites

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249610
• Other study ID #: Worksite_2014
• Status: Completed
• Phase: N/A
• First received: July 1, 2017
• Last updated: August 12, 2017
• Start date: March 11, 2014
• Est. completion date: June 15, 2017

Study information

• Verified date: August 2017
• Source: Diabetes Foundation, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 15, 2017
• Est. primary completion date: March 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Lifestyle Risk Reduction
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Lifestyle intervention
Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Diabetes Foundation, India	Abbott India Ltd, Sprim Global Investments Pte Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with reduced Body Mass Index	Body Mass Index measured in kg/m^2	6 months
Secondary	Number of subjects with reduced Fasting Blood Glucose	Fasting Blood Glucose measured in mg/dl	6 months