Diabetes, Heart Disease, Obesity
Conditions
Keywords
Nutrition, Occupational Health
Brief summary
This study will test the implementation, effectiveness, cost-effectiveness, and acceptability of a worksite lifestyle improvement program that includes lifestyle education classes led by trained individuals from the worksite and improvements in the worksite environment that will make it easier for employees at risk 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.
Detailed description
This study will implement and evaluate in a pre-post design trial the acceptability, delivery, effectiveness, and cost-effectiveness of a worksite-based lifestyle improvement package including a peer-led lifestyle change education program (described below) augmented with changes in the worksite environment that promote social support, healthy eating and exercise. The lifestyle education program will include 2000 adults with prediabetes (HbA1c of 5.7-6.4%) or unmedicated diabetes (HbA1c ≥ 6.5% identified at screening) across ten diverse worksites in India (changes to the worksite environment will impact a much broader population of employees). A mixed methods approach will be used to evaluate implementation of the program. Participants at high risk for diabetes or with unmedicated diabetes will be enrolled in a lifestyle intervention training program that includes strategies to maintain a healthy weight, maintain healthy blood glucose levels, eat a healthy diet, increase physical activity, overcome barriers, and build social support. Participants will be assigned two goals to achieve during lifestyle classes; to increase the physical activity to at least 150 minutes per week of moderate level activity and lose at least 5% of their baseline body weight. Participants also will be given knowledge and tools necessary to improve their diet quality and quantity.
Interventions
BEHAVIORALLifestyle 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.
Sponsors
Public Health Foundation of India
Madras Diabetes Research Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* BMI ≥23 kg/m2 and/or waist circumference ≥90 cm for men and ≥80 cm for women * Prediabetic (HbA1c of 5.7-6.4%) or diabetic (HbA1c≥6.5%)
Exclusion criteria
* Currently taking any diabetes medications * Pregnant or breastfeeding * History of heart disease, current serious illness, or conditions which would impede participation in an unsupervised physical activity and diet change program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching Two or More Cardiometabolic Risk Goals | Annually up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Fasting Plasma Glucose | Baseline, annually up to 2 years | 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. |
| Blood Pressure (BP) | Baseline, Annually up to 2 years | 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 |
| Mean Hemoglobin A1c (HbA1c) Level | Baseline, annually up to 2 years | HbA1c will be assessed via blood draw and processing annually, from baseline to the end of study follow-up (up to 2 years). |
| Mean Body Mass Index (BMI) | Baseline, Annually up to 2 years | 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). |
| Mean Body Weight | Baseline, Annually up to 2 years | 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). |
| Waist Circumference | Baseline, Annually up to 2 years | 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 of New Diabetes Cases | Baseline, end of follow up (up to 2 years post-baseline) | 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). |
| Prevalence of Hypertension | Annually up to 2 years | 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. |
| Mean Triglycerides Level | Baseline, annually up to 2 years | 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). |
| Mean Low Density Lipoprotein (LDL) | Baseline, Annually up to 2 years | 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). |
| Mean High Density Lipoprotein (HDL) | Baseline, Annually up to 2 years | 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 of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates | End of study follow-up (Up to 2 years post-intervention) | Number of participants with Dysglycemia (HbA1c \> 5.7%) that reach normoglycemia (HbA1c \< 5.7%) at the end of the study (up to two years). |
| Number of Patients Overweight or Obese | Baseline, Annually up to 2 years | 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. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,108 |
| Total | 2,108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 509 |
| Overall Study | Medical reasons not related to the study | 4 |
| Overall Study | No longer at worksite | 85 |
| Overall Study | Withdrawal by Subject | 148 |
Baseline characteristics
| Characteristic | Lifestyle Intervention Training Program |
|---|---|
| Age, Continuous | 45.83 years STANDARD_DEVIATION 8.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of participants at baseline without known diabetes | 1448 Participants |
| Region of Enrollment India | 2108 participants |
| Sex: Female, Male Female | 477 Participants |
| Sex: Female, Male Male | 1631 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 2,108 |
| other Total, other adverse events | 0 / 2,108 |
| serious Total, serious adverse events | 0 / 2,108 |
Outcome results
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.
Time frame: Annually up to 2 years
Population: Number of participants analyzed in each time point varies from overall number analyzed due to missing samples.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Intervention Training Program | Number of Participants Reaching Two or More Cardiometabolic Risk Goals | 1 year post-intervention | 485 Participants |
| Lifestyle Intervention Training Program | Number of Participants Reaching Two or More Cardiometabolic Risk Goals | 2 years post-intervention | 351 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
Time frame: Baseline, Annually up to 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Blood Pressure (BP) | Baseline Systolic Blood Pressure | 132.28 mmHg | Standard Deviation 16.64 |
| Lifestyle Intervention Training Program | Blood Pressure (BP) | Systolic Blood Pressure at 1 year post-intervention | 127 mmHg | Standard Deviation 14.28 |
| Lifestyle Intervention Training Program | Blood Pressure (BP) | Systolic Blood Pressure at 2 years post-intervention | 128.4 mmHg | Standard Deviation 15 |
| Lifestyle Intervention Training Program | Blood Pressure (BP) | Baseline Diastolic Blood Pressure | 85.21 mmHg | Standard Deviation 10.36 |
| Lifestyle Intervention Training Program | Blood Pressure (BP) | Diastolic Blood Pressure at 1 year post-intervention | 83.6 mmHg | Standard Deviation 9.4 |
| Lifestyle Intervention Training Program | Blood Pressure (BP) | Diastolic Blood Pressure at 2 years post-intervention | 83.8 mmHg | Standard Deviation 9.5 |
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).
Time frame: Baseline, Annually up to 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Mean Body Mass Index (BMI) | Baseline | 27.35 kg/m^2 | Standard Deviation 3.61 |
| Lifestyle Intervention Training Program | Mean Body Mass Index (BMI) | 1 year post-intervention | 27.2 kg/m^2 | Standard Deviation 3.7 |
| Lifestyle Intervention Training Program | Mean Body Mass Index (BMI) | 2 years post-intervention | 27.1 kg/m^2 | Standard Deviation 3.7 |
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).
Time frame: Baseline, Annually up to 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Mean Body Weight | Baseline body weight | 74.2 Kg | Standard Deviation 12.4 |
| Lifestyle Intervention Training Program | Mean Body Weight | 1 year post-intervention | 73.4 Kg | Standard Deviation 12.5 |
| Lifestyle Intervention Training Program | Mean Body Weight | 2 years post-intervention | 72.7 Kg | Standard Deviation 12.2 |
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.
Time frame: Baseline, annually up to 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Mean Fasting Plasma Glucose | Baseline Mean Fasting Plasma Glucose | 105.80 mg/dl | Standard Deviation 27.75 |
| Lifestyle Intervention Training Program | Mean Fasting Plasma Glucose | Mean Fasting Plasma Glucose at Ave 1 year post-intervention | 108.6 mg/dl | Standard Deviation 33.6 |
| Lifestyle Intervention Training Program | Mean Fasting Plasma Glucose | Mean Fasting Plasma Glucose at Ave 2 years post-intervention | 113.6 mg/dl | Standard Deviation 37.5 |
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).
Time frame: Baseline, annually up to 2 years
Population: Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Mean Hemoglobin A1c (HbA1c) Level | Baseline HbA1c (%) | 6.41 percentage of HbA1C | Standard Deviation 0.97 |
| Lifestyle Intervention Training Program | Mean Hemoglobin A1c (HbA1c) Level | Ave HbA1c (%) at 1 year follow-up visit | 6.1 percentage of HbA1C | Standard Deviation 1.1 |
| Lifestyle Intervention Training Program | Mean Hemoglobin A1c (HbA1c) Level | Ave HbA1c (%) at 2 years follow-up | 6.3 percentage of HbA1C | Standard Deviation 1.2 |
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).
Time frame: Baseline, Annually up to 2 years
Population: Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Mean High Density Lipoprotein (HDL) | Baseline | 43.54 mg/dl | Standard Deviation 9.18 |
| Lifestyle Intervention Training Program | Mean High Density Lipoprotein (HDL) | 1 year-post-intervention | 44.2 mg/dl | Standard Deviation 9.2 |
| Lifestyle Intervention Training Program | Mean High Density Lipoprotein (HDL) | 2 years post-intervention | 43.9 mg/dl | Standard Deviation 9.7 |
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).
Time frame: Baseline, Annually up to 2 years
Population: Number analyzed in one or more rows differs from overall number analyzed due to missing samples and lost to follow up patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Mean Low Density Lipoprotein (LDL) | Baseline LDL | 117.0 mg/dl | Standard Deviation 35.3 |
| Lifestyle Intervention Training Program | Mean Low Density Lipoprotein (LDL) | 1 year post-intervention | 119.0 mg/dl | Standard Deviation 35.8 |
| Lifestyle Intervention Training Program | Mean Low Density Lipoprotein (LDL) | 2 years post-intervention | 121.6 mg/dl | Standard Deviation 34.7 |
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).
Time frame: Baseline, annually up to 2 years
Population: Number analyzed in one or more rows differs from overall number analyzed due to lost to follow up patients and missing samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Mean Triglycerides Level | Baseline | 140.58 mg/dl | Standard Deviation 85.53 |
| Lifestyle Intervention Training Program | Mean Triglycerides Level | 1 year post-intervention | 148.8 mg/dl | Standard Deviation 95.2 |
| Lifestyle Intervention Training Program | Mean Triglycerides Level | 2 years post-intervention | 155.8 mg/dl | Standard Deviation 89 |
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Intervention Training Program | Number of New Diabetes Cases | Baseline | 660 Participants |
| Lifestyle Intervention Training Program | Number of New Diabetes Cases | End of study follow-up (up to 2 years post-baseline) | 481 Participants |
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.
Time frame: Baseline, Annually up to 2 years
Population: Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about the weight.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Intervention Training Program | Number of Patients Overweight or Obese | Overweight patients at Baseline | 639 Participants |
| Lifestyle Intervention Training Program | Number of Patients Overweight or Obese | Overweight patients at 1 year post-intervention | 653 Participants |
| Lifestyle Intervention Training Program | Number of Patients Overweight or Obese | Overweight patients at 2 years post-intervention | 604 Participants |
| Lifestyle Intervention Training Program | Number of Patients Overweight or Obese | Obese patients at Baseline | 863 Participants |
| Lifestyle Intervention Training Program | Number of Patients Overweight or Obese | Obese patients at 1 year post-intervention | 604 Participants |
| Lifestyle Intervention Training Program | Number of Patients Overweight or Obese | Obese patients at 2 years post-intervention | 524 Participants |
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).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lifestyle Intervention Training Program | Number of Patients With Prediabetes or Newly Detected Diabetes That Achieve Normoglycemia Rates | 330 Participants |
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.
Time frame: Annually up to 2 years
Population: Number analyzed in each time point include patients that completed each follow up visit and where able to provide data about Blood Pressure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Any Hypertension at 1 year post-intervention | 388 Participants |
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Hypertension Stage 1 at 1 year post-intervention | 307 Participants |
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Hypertension Stage 2 at 1 year post-intervention | 68 Participants |
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Hypertension Crisis at 1 year post-intervention | 13 Participants |
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Any Hypertension at 2 years post-intervention | 357 Participants |
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Hypertension Stage 1 at 2 years post-intervention | 280 Participants |
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Hypertension Stage 2 at 2 years post-intervention | 64 Participants |
| Lifestyle Intervention Training Program | Prevalence of Hypertension | Hypertension Crisis at 2 years post-intervention | 13 Participants |
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).
Time frame: Baseline, Annually up to 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention Training Program | Waist Circumference | Baseline | 95.5 cm | Standard Deviation 8.9 |
| Lifestyle Intervention Training Program | Waist Circumference | 1 year post-intervention | 93.7 cm | Standard Deviation 9.1 |
| Lifestyle Intervention Training Program | Waist Circumference | 2 years post-intervention | 94.0 cm | Standard Deviation 9.2 |