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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL125442 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Public Health Foundation of India | OTHER |
| Madras Diabetes Research Foundation | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention Training Program | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Annually up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Beth Weber, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madras Diabetes Research Foundation | Chennai | India | ||||
| Public Health Foundation of India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37957783 | Derived | 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. | |
| 37577514 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants analyzed in each time point varies from overall number analyzed due to missing samples. | Posted | Count of Participants | Participants | Annually up to 2 years |
|
2 years post-intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Beth Weber | Emory University | 404-712-1902 | mbweber@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2023 | Jun 29, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 27, 2018 | Mar 16, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006331 | Heart Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Baseline, Annually up to 2 years |
| 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). | Baseline, annually up to 2 years |
| 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). | Baseline, end of follow up (up to 2 years post-baseline) |
| 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. | Baseline, annually up to 2 years |
| 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). | Baseline, Annually up to 2 years |
| 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). | Baseline, Annually up to 2 years |
| 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). | Baseline, Annually up to 2 years |
| 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. | Baseline, Annually up to 2 years |
| 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. | Annually up to 2 years |
| 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). | Baseline, annually up to 2 years |
| 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). | Baseline, Annually up to 2 years |
| 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). | Baseline, Annually up to 2 years |
| 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). | End of study follow-up (Up to 2 years post-intervention) |
| New Delhi |
| India |
| No longer at worksite |
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| Medical reasons not related to the study |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Number of participants at baseline without known diabetes | Count of Participants | Participants |
|
|
|
| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, Annually up to 2 years |
|
|
|
| Secondary | 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). | Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples. | Posted | Mean | Standard Deviation | percentage of HbA1C | Baseline, annually up to 2 years |
|
|
|
| Secondary | 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). | 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. | Posted | Count of Participants | Participants | Baseline, end of follow up (up to 2 years post-baseline) |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | mg/dl | Baseline, annually up to 2 years |
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|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, Annually up to 2 years |
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | Kg | Baseline, Annually up to 2 years |
|
|
|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | cm | Baseline, Annually up to 2 years |
|
|
|
| Secondary | 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. | Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about the weight. | Posted | Count of Participants | Participants | Baseline, Annually up to 2 years |
|
|
|
| Secondary | 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. | Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about Blood Pressure. | Posted | Count of Participants | Participants | Annually up to 2 years |
|
|
|
| Secondary | 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). | Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples. | Posted | Mean | Standard Deviation | mg/dl | Baseline, annually up to 2 years |
|
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| Secondary | 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). | Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients. | Posted | Mean | Standard Deviation | mg/dl | Baseline, Annually up to 2 years |
|
|
|
| Secondary | 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). | Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients. | Posted | Mean | Standard Deviation | mg/dl | Baseline, Annually up to 2 years |
|
|
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| Secondary | 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). | The overall number of participants analyzed in this outcome refers to the number of patients at baseline without known diabetes. | Posted | Count of Participants | Participants | End of study follow-up (Up to 2 years post-intervention) |
|
|
|
| 4 |
| 2,108 |
| 0 |
| 2,108 |
| 0 |
| 2,108 |
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| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Systolic Blood Pressure at 2 years post-intervention |
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| Baseline Diastolic Blood Pressure |
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| Diastolic Blood Pressure at 1 year post-intervention |
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| Diastolic Blood Pressure at 2 years post-intervention |
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| Ave HbA1c (%) at 2 years follow-up |
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| Mean Fasting Plasma Glucose at Ave 2 years post-intervention |
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| 2 years post-intervention |
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| 2 years post-intervention |
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| 2 years post-intervention |
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| Overweight patients at 2 years post-intervention |
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| Obese patients at Baseline |
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| Obese patients at 1 year post-intervention |
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| Obese patients at 2 years post-intervention |
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| Hypertension Stage 2 at 1 year post-intervention |
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| Hypertension Crisis at 1 year post-intervention |
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| Any Hypertension at 2 years post-intervention |
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| Hypertension Stage 1 at 2 years post-intervention |
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| Hypertension Stage 2 at 2 years post-intervention |
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| Hypertension Crisis at 2 years post-intervention |
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| 2 years post-intervention |
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| 2 years post-intervention |
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| 2 years post-intervention |
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