Trial Outcomes & Findings for Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India (NCT NCT02813668)
NCT ID: NCT02813668
Last Updated: 2023-09-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2108 participants
Primary outcome timeframe
Annually up to 2 years
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
Lifestyle Intervention Training Program
Participants 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.
Lifestyle Intervention Training Program: 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.
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|---|---|
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Overall Study
STARTED
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2108
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Overall Study
COMPLETED
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1358
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Overall Study
NOT COMPLETED
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750
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Reasons for withdrawal
| Measure |
Lifestyle Intervention Training Program
Participants 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.
Lifestyle Intervention Training Program: 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.
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Overall Study
Death
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4
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Overall Study
Lost to Follow-up
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509
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Overall Study
Withdrawal by Subject
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148
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Overall Study
No longer at worksite
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85
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Overall Study
Medical reasons not related to the study
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4
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Baseline Characteristics
Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Baseline characteristics by cohort
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Age, Continuous
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45.83 years
STANDARD_DEVIATION 8.77 • n=5 Participants
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Sex: Female, Male
Female
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477 Participants
n=5 Participants
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Sex: Female, Male
Male
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1631 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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2108 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
India
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2108 participants
n=5 Participants
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Number of participants at baseline without known diabetes
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1448 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Annually up to 2 yearsPopulation: Number of participants analyzed in each time point varies from overall number analyzed due to missing samples.
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.
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=1411 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Number of Participants Reaching Two or More Cardiometabolic Risk Goals
1 year post-intervention
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485 Participants
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Number of Participants Reaching Two or More Cardiometabolic Risk Goals
2 years post-intervention
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351 Participants
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SECONDARY outcome
Timeframe: Baseline, Annually up to 2 yearsPopulation: Number of participants analyzed in each row differ from overall number analyzed due to patients unable to complete the visit or unable to provide the BP measure.
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
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Blood Pressure (BP)
Baseline Systolic Blood Pressure
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132.28 mmHg
Standard Deviation 16.64
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Blood Pressure (BP)
Systolic Blood Pressure at 1 year post-intervention
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127 mmHg
Standard Deviation 14.28
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Blood Pressure (BP)
Systolic Blood Pressure at 2 years post-intervention
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128.4 mmHg
Standard Deviation 15.0
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Blood Pressure (BP)
Baseline Diastolic Blood Pressure
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85.21 mmHg
Standard Deviation 10.36
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Blood Pressure (BP)
Diastolic Blood Pressure at 1 year post-intervention
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83.6 mmHg
Standard Deviation 9.4
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Blood Pressure (BP)
Diastolic Blood Pressure at 2 years post-intervention
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83.8 mmHg
Standard Deviation 9.50
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SECONDARY outcome
Timeframe: Baseline, annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples.
HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study follow-up (up to 2 years).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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|---|---|
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Mean Hemoglobin A1c (HbA1c) Level
Baseline HbA1c (%)
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6.41 percentage of HbA1C
Standard Deviation 0.97
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Mean Hemoglobin A1c (HbA1c) Level
Ave HbA1c (%) at 1 year follow-up visit
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6.1 percentage of HbA1C
Standard Deviation 1.1
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Mean Hemoglobin A1c (HbA1c) Level
Ave HbA1c (%) at 2 years follow-up
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6.3 percentage of HbA1C
Standard Deviation 1.2
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SECONDARY outcome
Timeframe: Baseline, end of follow up (up to 2 years post-baseline)Population: Number analyzed at ave 2 years post-intervention included number of participants that completed the ave 2 years post-intervention visit and provided data for diabetes incidence.
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).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Number of New Diabetes Cases
Baseline
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660 Participants
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Number of New Diabetes Cases
End of study follow-up (up to 2 years post-baseline)
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481 Participants
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SECONDARY outcome
Timeframe: Baseline, annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to missing blood samples for this outcome and patients that were lost to follow up.
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.
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Mean Fasting Plasma Glucose
Baseline Mean Fasting Plasma Glucose
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105.80 mg/dl
Standard Deviation 27.75
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Mean Fasting Plasma Glucose
Mean Fasting Plasma Glucose at Ave 1 year post-intervention
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108.6 mg/dl
Standard Deviation 33.6
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Mean Fasting Plasma Glucose
Mean Fasting Plasma Glucose at Ave 2 years post-intervention
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113.6 mg/dl
Standard Deviation 37.5
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SECONDARY outcome
Timeframe: Baseline, Annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to patients unable to complete the study visit and provide data for this outcome.
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).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Mean Body Mass Index (BMI)
Baseline
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27.35 kg/m^2
Standard Deviation 3.61
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Mean Body Mass Index (BMI)
1 year post-intervention
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27.2 kg/m^2
Standard Deviation 3.7
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Mean Body Mass Index (BMI)
2 years post-intervention
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27.1 kg/m^2
Standard Deviation 3.7
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SECONDARY outcome
Timeframe: Baseline, Annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to patients unable to complete the study visit and provide data for this outcome.
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).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Mean Body Weight
Baseline body weight
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74.2 Kg
Standard Deviation 12.4
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Mean Body Weight
1 year post-intervention
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73.4 Kg
Standard Deviation 12.5
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Mean Body Weight
2 years post-intervention
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72.7 Kg
Standard Deviation 12.2
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SECONDARY outcome
Timeframe: Baseline, Annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to patients unable to complete the study visit and provide data for this outcome.
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).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Waist Circumference
Baseline
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95.5 cm
Standard Deviation 8.9
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Waist Circumference
1 year post-intervention
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93.7 cm
Standard Deviation 9.1
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Waist Circumference
2 years post-intervention
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94.0 cm
Standard Deviation 9.2
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SECONDARY outcome
Timeframe: Baseline, Annually up to 2 yearsPopulation: Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about the weight.
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.
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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Number of Patients Overweight or Obese
Overweight patients at Baseline
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639 Participants
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Number of Patients Overweight or Obese
Overweight patients at 1 year post-intervention
|
653 Participants
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Number of Patients Overweight or Obese
Overweight patients at 2 years post-intervention
|
604 Participants
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Number of Patients Overweight or Obese
Obese patients at Baseline
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863 Participants
|
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Number of Patients Overweight or Obese
Obese patients at 1 year post-intervention
|
604 Participants
|
|
Number of Patients Overweight or Obese
Obese patients at 2 years post-intervention
|
524 Participants
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SECONDARY outcome
Timeframe: Annually up to 2 yearsPopulation: Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about Blood Pressure.
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.
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=1379 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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|---|---|
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Prevalence of Hypertension
Any Hypertension at 1 year post-intervention
|
388 Participants
|
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Prevalence of Hypertension
Hypertension Stage 1 at 1 year post-intervention
|
307 Participants
|
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Prevalence of Hypertension
Hypertension Stage 2 at 1 year post-intervention
|
68 Participants
|
|
Prevalence of Hypertension
Hypertension Crisis at 1 year post-intervention
|
13 Participants
|
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Prevalence of Hypertension
Any Hypertension at 2 years post-intervention
|
357 Participants
|
|
Prevalence of Hypertension
Hypertension Stage 1 at 2 years post-intervention
|
280 Participants
|
|
Prevalence of Hypertension
Hypertension Stage 2 at 2 years post-intervention
|
64 Participants
|
|
Prevalence of Hypertension
Hypertension Crisis at 2 years post-intervention
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples.
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).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=2108 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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|---|---|
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Mean Triglycerides Level
Baseline
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140.58 mg/dl
Standard Deviation 85.53
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Mean Triglycerides Level
1 year post-intervention
|
148.8 mg/dl
Standard Deviation 95.2
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Mean Triglycerides Level
2 years post-intervention
|
155.8 mg/dl
Standard Deviation 89.0
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SECONDARY outcome
Timeframe: Baseline, Annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients.
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).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=1630 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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|---|---|
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Mean Low Density Lipoprotein (LDL)
Baseline LDL
|
117.0 mg/dl
Standard Deviation 35.3
|
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Mean Low Density Lipoprotein (LDL)
1 year post-intervention
|
119.0 mg/dl
Standard Deviation 35.8
|
|
Mean Low Density Lipoprotein (LDL)
2 years post-intervention
|
121.6 mg/dl
Standard Deviation 34.7
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SECONDARY outcome
Timeframe: Baseline, Annually up to 2 yearsPopulation: Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients.
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).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=1630 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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|---|---|
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Mean High Density Lipoprotein (HDL)
Baseline
|
43.54 mg/dl
Standard Deviation 9.18
|
|
Mean High Density Lipoprotein (HDL)
1 year-post-intervention
|
44.2 mg/dl
Standard Deviation 9.2
|
|
Mean High Density Lipoprotein (HDL)
2 years post-intervention
|
43.9 mg/dl
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: End of study follow-up (Up to 2 years post-intervention)Population: The overall number of participants analyzed in this outcome refers to the number of patients at baseline without known diabetes.
Number of participants with Dysglycemia (HbA1c \> 5.7%) that reach normoglycemia (HbA1c \< 5.7%) at the end of the study (up to two years).
Outcome measures
| Measure |
Lifestyle Intervention Training Program
n=1448 Participants
Participants 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.
Lifestyle Intervention Training Program: 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.
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|---|---|
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Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates
|
330 Participants
|
Adverse Events
Lifestyle Intervention Training Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place