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AzTrials

DiabetesNCT02813668

Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India

A study testing Lifestyle Intervention Training Program in people with Diabetes and Heart Disease, run by Emory University at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will test the implementation, effectiveness, cost-effectiveness, and acceptability of a worksite lifestyle improvement program that includes lifestyle education classes led by trained individuals from the worksite and improvements in the worksite environment that will make it easier for employees at risk… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Heart Disease, Obesity
What is being tested?
Lifestyle Intervention Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,108 participants
Where
2 sitesIndia
Study dates
2 May 2017to 15 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI ≥23 kg/m2 and/or waist circumference ≥90 cm for men and ≥80 cm for women
  • Prediabetic (HbA1c of 5.7-6.4%) or diabetic (HbA1c≥6.5%)

Who cannot join

  • Currently taking any diabetes medications
  • Pregnant or breastfeeding
  • History of heart disease, current serious illness, or conditions which would impede participation in an unsupervised physical activity and diet change program

Trial locations and contacts

2 sites in 1 country.

India2 sites

  • Madras Diabetes Research Foundation

    Chennai

  • Public Health Foundation of India

    New Delhi

Other trials in India

About this study

This study will test the implementation, effectiveness, cost-effectiveness, and acceptability of a worksite lifestyle improvement program that includes lifestyle education classes led by trained individuals from the worksite and improvements in the worksite environment that will make it easier for employees at risk for diabetes or with unmedicated diabetes to lose weight, exercise more, and eat a healthier diet. A total of 2000 participants across 10 worksites in South, Central, and East India will be involved in this study.

Read the detailed description

This study will implement and evaluate in a pre-post design trial the acceptability, delivery, effectiveness, and cost-effectiveness of a worksite-based lifestyle improvement package including a peer-led lifestyle change education program (described below) augmented with changes in the worksite environment that promote social support, healthy eating and exercise. The lifestyle education program will include 2000 adults with prediabetes (HbA1c of 5.7-6.4%) or unmedicated diabetes (HbA1c ≥ 6.5% identified at screening) across ten diverse worksites in India (changes to the worksite environment will impact a much broader population of employees). A mixed methods approach will be used to evaluate implementation of the program.

Participants at high risk for diabetes or with unmedicated diabetes will be enrolled in a lifestyle intervention training program that includes strategies to maintain a healthy weight, maintain healthy blood glucose levels, eat a healthy diet, increase physical activity, overcome barriers, and build social support. Participants will be assigned two goals to achieve during lifestyle classes; to increase the physical activity to at least 150 minutes per week of moderate level activity and lose at least 5% of their baseline body weight. Participants also will be given knowledge and tools necessary to improve their diet quality and quantity.

Being tested
Lifestyle Intervention Training Program
Keywords
Nutrition, Occupational Health
Medical subject headings
Diabetes Mellitus, Heart Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle Intervention Training ProgramBehavioural

    Participants will be placed into a peer-led classes of 10 to 12 people. The curriculum contains sixteen core sessions that occur weekly for four months followed by an eight month maintenance period. During lifestyle classes, participants will learn strategies for eating a healthy diet, increasing physical activity, overcoming barriers, building social support, reaching and maintaining a healthy wait, and maintaining healthy blood glucose levels. Participants will also be assigned goals to achieve; increasing physical activity and losing 5% of their baseline body weight. During maintenance, participants will receive biweekly SMS text messages providing lifestyle advice tips and encouragement.

Study groups in NCT02813668
Study groupRoleWhat they receive
Lifestyle Intervention Training ProgramExperimentalParticipants at risk for developing diabetes or with unmedicated diabetes will participate in a lifestyle intervention training program. Individuals in the training program, as well as un-enrolled workers at the study sites, will be exposed to positive changes at the worksite to promote increased physical activity and healthier diets.
Receives: Behavioral: Lifestyle Intervention Training Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reaching Two or More Cardiometabolic Risk Goals

    The primary outcome assessing program effectiveness is a composite of achieving two or more cardiometabolic risk goals; participants will be scored on the number of risk factors they improve on (0-3) with success delineated by a HbA1c decrease ≥0.5%; a systolic blood pressure decrease ≥5 mm Hg; and a decrease in plasma triglycerides ≥10 mg/dl.

    Number of participants reaching two or more cardiometabolic Risk Goals will be reported.

    Measured: Annually up to 2 years

Secondary outcomes (13)

  1. Blood Pressure (BP)

    Blood pressure in mmHg will be measured with an automated blood pressure machine annually, from baseline to the end of follow-up (up to two years). Blood pressure measurements are as follows:

    Normal = systolic, less than 120 and diastolic, less than 80 Prehypertension = systolic, 120 - 139 or diastolic , 80 - 89 High Blood Pressure/(Hypertension) Stage 1 = systolic, 140 - 159 or diastolic, 90 - 99 High Blood Pressure (Hypertension) Stage 2 = systolic, 160 or higher or diastolic, 100 or higher Hypertensive Crisis (Emergency care needed) = systolic, Higher than 180 or diastolic, Higher than 110

    Measured: Baseline, Annually up to 2 years

  2. Mean Hemoglobin A1c (HbA1c) Level

    HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study follow-up (up to 2 years).

    Measured: Baseline, annually up to 2 years

  3. Number of New Diabetes Cases

    Number of new cases of diabetes is the number of participants diagnosed with a new onset of diabetes using the HbA1c test (HbA1c levels of 6.5% or higher indicate diabetes). Number of new cases of diabetes will be collected annually, from baseline to the end of study follow-up (up to 2 years).

    Measured: Baseline, end of follow up (up to 2 years post-baseline)

  4. Mean Fasting Plasma Glucose

    Fasting plasma glucose will be assessed via blood draw. Fasting plasma glucose will be collected annually, from baseline to the end of study follow-up (up to 2 years). A normal fasting blood sugar on awakening is less under 100 mg/dl.

    Measured: Baseline, annually up to 2 years

  5. Mean Body Mass Index (BMI)

    BMI will be calculated in kg/m^2 from annual measures of height (m) and weight (kg). BMI will be collected annually, from baseline to the end of study follow-up (up to 2 years).

    Measured: Baseline, Annually up to 2 years

  6. Mean Body Weight

    Weight will be measured in kilograms using a digital scale. Weight will be collected annually post-intervention from baseline to the end of study follow-up (up to 2 years).

    Measured: Baseline, Annually up to 2 years

  7. Waist Circumference

    Waist circumference will be measured in centimeters using a non-elastic measuring tape. Waist circumference will be collected annually, from baseline to the end of study follow-up (up to 2 years).

    Measured: Baseline, Annually up to 2 years

  8. Number of Patients Overweight or Obese

    The number of participants of participants who are overweight or obese will be calculated from the body mass index annually, from baseline to the end of study follow-up (up to two years). Overweight and Obesity will be defined using WHO-recommended outpoints for Asian populations: overweight = BMI of 23-<27.5 kg/m^2 and obese = BMI of 27.5 kg/m2 or greater.

    Measured: Baseline, Annually up to 2 years

  9. Prevalence of Hypertension

    Number of participants with hypertension will be calculated from annual blood pressure measurements, from baseline to the end of study follow-up (up to two years). Hypertension is defined as the following: Stage 1: systolic 140 - 159 mmHg or diastolic 90 - 99 mmHg; Stage 2: systolic 160 mmHg or higher, or diastolic 100 mmHg or higher; hypertensive crisis (emergency care needed): systolic higher than 180 mmHg or diastolic higher than 110 mmHg.

    Measured: Annually up to 2 years

  10. Mean Triglycerides Level

    Plasma triglycerides will be assessed via blood draw and will be assessed annually, from baseline to the end of study follow-up (up to two years).

    Measured: Baseline, annually up to 2 years

  11. Mean Low Density Lipoprotein (LDL)

    LDL cholesterol will be assessed via blood draw and will be measured annually, from baseline to the end of study follow-up (up to two years).

    Measured: Baseline, Annually up to 2 years

  12. Mean High Density Lipoprotein (HDL)

    HDL cholesterol will be assessed via blood draw and will be measured annually, from baseline to the end of study follow-up (up to 2 years).

    Measured: Baseline, Annually up to 2 years

  13. Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates

    Number of participants with Dysglycemia (HbA1c > 5.7%) that reach normoglycemia (HbA1c < 5.7%) at the end of the study (up to two years).

    Measured: End of study follow-up (Up to 2 years post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2016 (estimated)
  2. Study start2 May 2017
  3. Primary completion15 Jan 2022
  4. Study completion15 Jan 2022

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813668
Sponsor's protocol ID
IRB00080327
Other IDs
R01HL125442
Status last verified
Sep 2023
First submitted
17 Jun 2016
Last updated
21 Sep 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weber MB, Rhodes EC, Ranjani H, Jeemon P, Ali MK, Hennink MM, Anjana RM, Mohan V, Narayan KMV, Prabhakaran D. Adapting and scaling a proven diabetes prevention program across 11 worksites in India: the INDIA-WORKS trial. Implement Sci Commun. 2023 Nov 13;4(1):134. doi: 10.1186/s43058-023-00516-1.

    PubMed 37957783

  • Weber MB, Rhodes EC, Ranjani H, Jeemon P, Ali MK, Hennink MM, Anjana RM, Mohan V, Narayan KV, Prabhakaran D. Adapting and scaling a proven diabetes prevention program across 11 worksites in India: the INDIA-WORKS trial. Res Sq [Preprint]. 2023 Aug 4:rs.3.rs-3143470. doi: 10.21203/rs.3.rs-3143470/v1.

    PubMed 37577514

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Intervention Training Program in people with Diabetes and Heart Disease, run by Emory University at 2 sites in 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 3 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants Reaching Two or More Cardiometabolic Risk Goals (time frame: Annually up to 2 years). 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 NCT02813668, which also lists 2 linked publications.

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 21 Sep 2023.

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