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OpenTrials
Completed

NCT Number: NCT03249610

Randomized Control Trial for Overweight Employees in Worksites

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lifestyle Risk Reduction Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Risk Reduction Behavior

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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

Primary outcomes

  1. Number of subjects with reduced Body Mass Index

    Time frame: 6 months

    Body Mass Index measured in kg/m^2

Secondary outcomes

  1. Number of subjects with reduced Fasting Blood Glucose

    Time frame: 6 months

    Fasting Blood Glucose measured in mg/dl

Sponsors and collaborators

Lead sponsor

Diabetes Foundation, India

Other

Collaborators

  • Abbott
  • Sprim Advanced Life Sciences

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Aug 15, 2017
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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