Diabetes Mellitus, Type 2NCT03249610
Randomized Control Trial for Overweight Employees in Worksites
A study testing Lifestyle intervention in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Diabetes Foundation, India.
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… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metabolic Syndrome, Lifestyle Risk Reduction
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2014to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years
- Individuals who are willing to participate in the study
Who cannot join
- 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
About this study
Official title: Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors
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.
Read the 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.
- Being tested
- Lifestyle intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors
| Study group | Role | What they receive |
|---|---|---|
| Jindal Steel Pvt Ltd | Experimental | Lifestyle intervention given Receives: Behavioral: Lifestyle intervention |
| Maruti Udyog Ltd | Experimental | Lifestyle intervention given Receives: Behavioral: Lifestyle intervention |
| Tata Capital | No intervention | Control arm so no intervention given |
| Powergrid Corporation | No intervention | Control arm so no intervention given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with reduced Body Mass Index
Body Mass Index measured in kg/m^2
Measured: 6 months
Secondary outcomes (1)
Number of subjects with reduced Fasting Blood Glucose
Fasting Blood Glucose measured in mg/dl
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start11 Mar 2014
- Primary completion12 Mar 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Collaborators
- Sprim Advanced Life Sciences, Abbott
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Dr. Anoop Misra, Principal investigator, Diabetes Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249610
- Sponsor's protocol ID
- Worksite_2014
- Status last verified
- Aug 2017
- First submitted
- 1 Jul 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29318159
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Worksite Intervention Trial With Multi-Component Lifestyle Intervention and Digital Health Platform for Reduction of Body Weight and Cardio-metabolic Risk Factors
- ClinicalTrials.gov ID
- NCT03249610
- Acronym / sponsor ID
- Worksite_2014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Collaborators
- Sprim Advanced Life Sciences, Abbott
- Study start
- 11 Mar 2014 (actual)
- Primary completion
- 12 Mar 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Jindal Steel Pvt Ltd | Experimental | Behavioral: Lifestyle interventionLifestyle intervention given |
| Maruti Udyog Ltd | Experimental | Behavioral: Lifestyle interventionLifestyle intervention given |
| Tata Capital | No intervention | –Control arm so no intervention given |
| Powergrid Corporation | No intervention | –Control arm so no intervention given |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Overweight (≥23kg/m 2 ) individuals in the age group 25-55 years
- Individuals who are willing to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionIntervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors | Behavioural | Jindal Steel Pvt Ltd, Maruti Udyog Ltd |
Primary outcome
Number of subjects with reduced Body Mass Index
Time frame: 6 months
Body Mass Index measured in kg/m^2
1 secondary outcome
Number of subjects with reduced Fasting Blood Glucose
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Derived from this study: PubMed 29318159Shrivastava 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Anoop Misra principal investigator
Diabetes Foundation, India
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Diabetes Foundation, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with reduced Body Mass Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.