Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-23 @ 5:53 PM
Study NCT ID:
NCT02813668
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2016-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbweber@emory.edu', 'phone': '404-712-1902', 'title': 'Dr. Mary Beth Weber', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years post-intervention', 'eventGroups': [{'id': 'EG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.', 'otherNumAtRisk': 2108, 'deathsNumAtRisk': 2108, 'otherNumAffected': 0, 'seriousNumAtRisk': 2108, 'deathsNumAffected': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reaching Two or More Cardiometabolic Risk Goals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1411', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': '1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1411', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '485', 'groupId': 'OG000'}]}]}, {'title': '2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1193', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Annually up to 2 years', 'description': '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.\n\nNumber of participants reaching two or more cardiometabolic Risk Goals will be reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants analyzed in each time point varies from overall number analyzed due to missing samples.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '132.28', 'spread': '16.64', 'groupId': 'OG000'}]}]}, {'title': 'Systolic Blood Pressure at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '127', 'spread': '14.28', 'groupId': 'OG000'}]}]}, {'title': 'Systolic Blood Pressure at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '128.4', 'spread': '15.0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.21', 'spread': '10.36', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.6', 'spread': '9.4', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.8', 'spread': '9.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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:\n\nNormal = 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', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Hemoglobin A1c (HbA1c) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline HbA1c (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.41', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': 'Ave HbA1c (%) at 1 year follow-up visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1418', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Ave HbA1c (%) at 2 years follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, annually up to 2 years', 'description': 'HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study follow-up (up to 2 years).', 'unitOfMeasure': 'percentage of HbA1C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples.'}, {'type': 'SECONDARY', 'title': 'Number of New Diabetes Cases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '660', 'groupId': 'OG000'}]}]}, {'title': 'End of study follow-up (up to 2 years post-baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1448', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '481', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, end of follow up (up to 2 years post-baseline)', 'description': '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline Mean Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1628', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '105.80', 'spread': '27.75', 'groupId': 'OG000'}]}]}, {'title': 'Mean Fasting Plasma Glucose at Ave 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1356', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '108.6', 'spread': '33.6', 'groupId': 'OG000'}]}]}, {'title': 'Mean Fasting Plasma Glucose at Ave 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1030', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '113.6', 'spread': '37.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, annually up to 2 years', 'description': '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.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.35', 'spread': '3.61', 'groupId': 'OG000'}]}]}, {'title': '1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1378', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.2', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': '2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '3.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Mean Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline body weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '12.4', 'groupId': 'OG000'}]}]}, {'title': '1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1381', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.4', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': '2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1255', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '12.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.5', 'spread': '8.9', 'groupId': 'OG000'}]}]}, {'title': '1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1377', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': '2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.0', 'spread': '9.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Overweight or Obese', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Overweight patients at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '639', 'groupId': 'OG000'}]}]}, {'title': 'Overweight patients at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1378', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '653', 'groupId': 'OG000'}]}]}, {'title': 'Overweight patients at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '604', 'groupId': 'OG000'}]}]}, {'title': 'Obese patients at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '863', 'groupId': 'OG000'}]}]}, {'title': 'Obese patients at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1378', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '604', 'groupId': 'OG000'}]}]}, {'title': 'Obese patients at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '524', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about the weight.'}, {'type': 'SECONDARY', 'title': 'Prevalence of Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Any Hypertension at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '388', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension Stage 1 at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension Stage 2 at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension Crisis at 1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1379', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Any Hypertension at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension Stage 1 at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '280', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension Stage 2 at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Hypertension Crisis at 2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Annually up to 2 years', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about Blood Pressure.'}, {'type': 'SECONDARY', 'title': 'Mean Triglycerides Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1630', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '140.58', 'spread': '85.53', 'groupId': 'OG000'}]}]}, {'title': '1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1398', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '148.8', 'spread': '95.2', 'groupId': 'OG000'}]}]}, {'title': '2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1189', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '155.8', 'spread': '89.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, annually up to 2 years', 'description': '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).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples.'}, {'type': 'SECONDARY', 'title': 'Mean Low Density Lipoprotein (LDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1630', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline LDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1630', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '117.0', 'spread': '35.3', 'groupId': 'OG000'}]}]}, {'title': '1 year post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1398', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119.0', 'spread': '35.8', 'groupId': 'OG000'}]}]}, {'title': '2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '121.6', 'spread': '34.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients.'}, {'type': 'SECONDARY', 'title': 'Mean High Density Lipoprotein (HDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1630', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1630', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.54', 'spread': '9.18', 'groupId': 'OG000'}]}]}, {'title': '1 year-post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1398', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.2', 'spread': '9.2', 'groupId': 'OG000'}]}]}, {'title': '2 years post-intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1189', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.9', 'spread': '9.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1448', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '330', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of study follow-up (Up to 2 years post-intervention)', 'description': 'Number of participants with Dysglycemia (HbA1c \\> 5.7%) that reach normoglycemia (HbA1c \\< 5.7%) at the end of the study (up to two years).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed in this outcome refers to the number of patients at baseline without known diabetes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1358'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '750'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '509'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '148'}]}, {'type': 'No longer at worksite', 'reasons': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'Medical reasons not related to the study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2108', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lifestyle Intervention Training Program', 'description': '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.\n\nLifestyle 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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.83', 'spread': '8.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '477', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1631', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2108', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '2108', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants at baseline without known diabetes', 'classes': [{'categories': [{'measurements': [{'value': '1448', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-31', 'size': 500171, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-29T13:14', 'hasProtocol': True}, {'date': '2018-11-27', 'size': 192561, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-16T16:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'dispFirstSubmitDate': '2023-01-12', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2016-06-17', 'dispFirstSubmitQcDate': '2023-01-12', 'resultsFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2016-06-22', 'dispFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-16', 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reaching Two or More Cardiometabolic Risk Goals', 'timeFrame': 'Annually up to 2 years', 'description': '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.\n\nNumber of participants reaching two or more cardiometabolic Risk Goals will be reported.'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure (BP)', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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:\n\nNormal = 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'}, {'measure': 'Mean Hemoglobin A1c (HbA1c) Level', 'timeFrame': 'Baseline, annually up to 2 years', 'description': 'HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study follow-up (up to 2 years).'}, {'measure': 'Number of New Diabetes Cases', 'timeFrame': 'Baseline, end of follow up (up to 2 years post-baseline)', 'description': '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).'}, {'measure': 'Mean Fasting Plasma Glucose', 'timeFrame': 'Baseline, annually up to 2 years', 'description': '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.'}, {'measure': 'Mean Body Mass Index (BMI)', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).'}, {'measure': 'Mean Body Weight', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).'}, {'measure': 'Waist Circumference', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).'}, {'measure': 'Number of Patients Overweight or Obese', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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.'}, {'measure': 'Prevalence of Hypertension', 'timeFrame': 'Annually up to 2 years', 'description': '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.'}, {'measure': 'Mean Triglycerides Level', 'timeFrame': 'Baseline, annually up to 2 years', 'description': '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).'}, {'measure': 'Mean Low Density Lipoprotein (LDL)', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).'}, {'measure': 'Mean High Density Lipoprotein (HDL)', 'timeFrame': 'Baseline, Annually up to 2 years', 'description': '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).'}, {'measure': 'Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates', 'timeFrame': 'End of study follow-up (Up to 2 years post-intervention)', 'description': 'Number of participants with Dysglycemia (HbA1c \\> 5.7%) that reach normoglycemia (HbA1c \\< 5.7%) at the end of the study (up to two years).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Occupational Health'], 'conditions': ['Diabetes', 'Heart Disease', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '37957783', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37577514', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥23 kg/m2 and/or waist circumference ≥90 cm for men and ≥80 cm for women\n* Prediabetic (HbA1c of 5.7-6.4%) or diabetic (HbA1c≥6.5%)\n\nExclusion Criteria:\n\n* Currently taking any diabetes medications\n* Pregnant or breastfeeding\n* History of heart disease, current serious illness, or conditions which would impede participation in an unsupervised physical activity and diet change program'}, 'identificationModule': {'nctId': 'NCT02813668', 'briefTitle': 'Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Worksite Lifestyle Program for Reducing Diabetes and Cardiovascular Risk in India', 'orgStudyIdInfo': {'id': 'IRB00080327'}, 'secondaryIdInfos': [{'id': 'R01HL125442', 'link': 'https://reporter.nih.gov/quickSearch/R01HL125442', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Intervention Training Program', 'description': '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.', 'interventionNames': ['Behavioral: Lifestyle Intervention Training Program']}], 'interventions': [{'name': 'Lifestyle Intervention Training Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Lifestyle Intervention Training Program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chennai', 'country': 'India', 'facility': 'Madras Diabetes Research Foundation', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Public Health Foundation of India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Mary Beth Weber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Foundation of India', 'class': 'OTHER'}, {'name': 'Madras Diabetes Research Foundation', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mary Beth Weber', 'investigatorAffiliation': 'Emory University'}}}}