Randomized Control Trial for Overweight Employees in Worksites

Diabetes Foundation, India

Status: Completed

Conditions: Lifestyle Risk Reduction; Diabetes Mellitus, Type 2; Metabolic Syndrome

Treatments: Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03249610

Worksite_2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Jindal Steel Pvt Ltd

Experimental group

Description:

Lifestyle intervention given

Treatment:

Behavioral: Lifestyle intervention

Maruti Udyog Ltd

Experimental group

Description:

Lifestyle intervention given

Treatment:

Behavioral: Lifestyle intervention

Tata Capital

No Intervention group

Description:

Control arm so no intervention given

Powergrid Corporation

No Intervention group

Description:

Control arm so no intervention given