Type 2 Diabetes
Conditions
Keywords
Diabetes
Brief summary
This trial investigates the value created by the highly innovative Fresh Food Farmacy (FFF) program at Geisinger Health. The program provides food-insecure diabetics with healthy food for their entire household: at least two meals per day, five days a week. The program also provides education on how to prepare the food, and education on healthy living including diabetes self management. The research measures the effects of the FFF program on patient health and wellbeing.
Detailed description
This is a pragmatic, prospective, randomized controlled trial of Geisinger's Fresh Food Farmacy (FFF) program as the program expands to new sites. Qualifying subjects will be randomized 1:1 to receive either early participation in the FFF program (treatment group) or later participation (control group). Approximately 500 Geisinger subjects will participate in this study with about half assigned to the treatment group and about half to the control group. The treatment group will begin the program soon after trial recruitment: the Begin Now group. The control group will begin the program after 6 months: the Begin Later group. Approximately 2000 household members will be included in the data-only portion of the research. Outcomes will include clinical measures, such as HbA1c, survey responses including self-assessed health measures, and utilization / healthy-behavior measures from EHR and paid claims data. These will be measured for subjects and their household members.
Interventions
OTHERFresh Food Farmacy
Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
Sponsors
Massachusetts Institute of Technology
Cornell University
Stanford University
Geisinger Clinic
John B Bulger, DO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Type II Diabetes and an HbA1c ≥ 8.0 as determined by the most recent measurement in the Geisinger EMR within the prior 12 months * Food insecure based on a two-question survey instrument * Age \> 17 & Age \<86 * Living within geographic reach of the program (Lewistown, PA and Scranton, PA)
Exclusion criteria
* Already enrolled in FFF in Shamokin * Not English speaking (working on changing this as the program evolves) * On hospice or palliative care * Acute or chronic psychosis * Resides in a facility which provides meals * Active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including: * Cancer; active treatment * Steroid dependent asthma/ COPD/ emphysema * Steroid dependent Colitis * Chronic Kidney Disease with GFR\< 30 mg/mmol * Celiac disease * Cirrhosis * Steroid dependent arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months after trial enrollment | Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood. Units are percentages; for differences between HbA1c values, units are percentage points. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outpatient Payments | 6 and 12 months after trial enrollment | Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment. |
| Times Eating Fruit in the Past 7 Days | 6 and 12 months after trial enrollment | Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fruit. |
| Times Eating Dark Green Vegetables in the Past 7 Days | 6 and 12 months after trial enrollment | Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate dark green vegetables. |
| Times Drinking Sweetened Beverages in the Past 7 Days | 6 and 12 months after trial enrollment | Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient drank sweetened beverages. |
| Times Eating Out in the Past 7 Days | 6 and 12 months after trial enrollment | Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fast food, takeout, or at a restaurant. |
| Participants Answering Yes for Diet Improvement Compared to One Year Ago | 6 and 12 months after trial enrollment | Patient-reported measure of diet improvement: Survey question: Do you believe your diet has improved compared to one year ago?. |
| Mean Proportion of Diabetes Knowledge Questions Answered Correctly | 6 and 12 months after trial enrollment | The proportion of questions testing patients' knowledge of how different factors contribute to blood sugar answered correctly. |
| Engagement Index Score | 6 and 12 months after trial enrollment | Survey-based index score for patient-reported positive engagement outcomes. Scores range from 0 to 1. Scores are standardized so that the control group always has a mean score of 0 and standard deviation of 1. Higher scores reflect better outcomes---here, better engagement with the program. Scores composite results from multiple survey questions while adjusting for covariance between questions. |
| Number of Outpatient Visits Claimed by Insurance | 6 and 12 months after trial enrollment | Healthcare utilization: Number of outpatient claims among continuously enrolled/insured subjects during the relevant time frame after trial enrollment. |
| Number of Inpatient and Emergency Department Visits Claimed by Insurance | 6 and 12 months after trial enrollment | Healthcare utilization: Number of inpatient and emergency department claims among continuously enrolled/insured subjects during the relevant time frame after enrollment. |
| Proportion of Participants Filing Outpatient Insurance Claims With Insurance | 6 and 12 months after trial enrollment | The number of subjects who were continuously enrolled/insured who had any outpatient claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm. |
| Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance | 6 and 12 months after trial enrollment | The number of subjects who were continuously enrolled/insured who had any inpatient or emergency department claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm. |
| Inpatient and Emergency Department Payments | 6 and 12 months after trial enrollment | Healthcare utilization: Total value (USD) of inpatient and emergency department payments among continuously enrolled/insured subjects during the relevant time frame after enrollment. |
| Number of Visits to a Dietician | 6 and 12 months after trial enrollment | The number of times an individual participant completed a medical appointment with a dietician in the relevant time frame, based on electronic health records. |
| Number of Diabetes Self-Management Trainings Completed | 6 and 12 months after trial enrollment | The number of times an individual participant completed a Diabetes Self-Management Training (DSMT) in the relevant time frame, based on electronic health records. |
| Number of Visits to an Endocrinologist | 6 and 12 months after trial enrollment | The number of times an individual participant completed a medical appointment with an endocrinologist in the relevant time frame, based on electronic health records. |
| Number of Weight Loss and Weight Management Appointments Completed | 6 and 12 months after trial enrollment | The number of times an individual participant completed a medical appointment regarding weight loss or weight management in the relevant time frame, based on electronic health records. |
| HbA1c | 12 months after trial enrollment | Glycated hemoglobin. Units are percentages (for differences, percentage points) reflecting the average share of glucose in the bloodstream over the previous 2-3 months. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome. |
| Fasting Glucose | 6 and 12 months after trial enrollment | Fasting blood glucose is a measure of blood sugar control over a short time period (the blood glucose content after an overnight fast). Units are mg/dL. To convert to mmol/L (SI), multiply by 0.0113. Lower fasting blood glucose levels indicate better health within the context of this study. |
| Weight (lb) | 6 and 12 months after trial enrollment | Weight in pounds. In the context of this study, higher values are considered a worse outcome. SI conversion factor: To convert pounds to kilograms, multiply by 0.4536. |
| Body Mass Index | 6 and 12 months after trial enrollment | Body Mass Index (BMI) in kg/m\^2. BMI is computed using weight (lb) and height (in). The CDC's healthy reference range for BMI among adults aged 20 and older is 18.5 to 24.9. BMI values greater than or equal to 30.0 indicate obesity. In the context of this study, higher BMI is considered a worse outcome. |
| Total Cholesterol | 6 and 12 months after trial enrollment | Total cholesterol in mg/dL. The CDC recommends total cholesterol levels around 150 mg/dL and classifies levels of 200 mg/dL and above as unhealthy (hyperlipidemia). In the context of this study, higher total cholesterol indicates a worse outcome. SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259. |
| LDL Cholesterol | 6 and 12 months after trial enrollment | Low-density lipoprotein (LDL) cholesterol, measured in mg/dL. The CDC recommends LDL levels of 100 mg/dL or below. In the context of this study, higher levels of LDL indicate a worse outcome. SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259. |
| HDL Cholesterol | 6 and 12 months after trial enrollment | High-density lipoprotein (HDL) cholesterol, measured in mg/dL. The CDC recommends HDL levels of at least 40 mg/dL in men and 50 mg/dL in women. In the context of this study, higher levels of HDL indicate a better outcome. SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0259. |
| Triglycerides | 6 and 12 months after trial enrollment | Triglycerides, measured in mg/dL. The CDC recommends levels of triglycerides below 150 mg/dL. In the context of this study, higher levels of triglycerides indicate worse outcomes. SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0113. |
| Systolic Blood Pressure | 6 and 12 months after trial enrollment | Systolic blood pressure, measured in mm Hg. The CDC identifies normal healthy systolic blood pressure as below 120 mm Hg. The American College of Cardiology identifies 120 to 129 mm Hg as elevated blood pressure and 130 mm Hg and higher as hypertensive. Higher systolic blood pressure levels indicate worse outcomes. |
| Diastolic Blood Pressure | 6 and 12 months after trial enrollment | Diastolic blood pressure, measured in mm Hg. The American College of Cardiology identifies normal diastolic blood pressure as below 80 mm Hg and elevated/hypertensive diastolic blood pressure as 80 mm Hg or above. Higher levels of diastolic blood pressure indicate worse outcomes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose for Household Members | 6 months and 12 months | Fasting glucose as available in EHR records |
| Healthy Behaviors Observed in Electronic Health Record | 6 months and 12 months | Healthy behaviors observed in electronic health record, including preventive care and appointments kept |
| Healthy Behaviors Observed in Paid Claims HEDIS Measures | 6 months and 12 months | Healthy behaviors observed in paid claims using Healthcare Effectiveness Data and Information Set (HEDIS) measures. These measures were not collected for this study. |
| HbA1c for Household Members | 6 months and 12 months | HbA1c available in EHR records |
| Weight for Household Members | 6 months and 12 months | Weight in pounds as available in EHR records |
| BMI for Household Members | 6 months and 12 months | BMI in kg/m\^2 in pounds as available in EHR records |
| Cholesterol for Household Members | 6 months and 12 months | Cholesterol as available in EHR records |
| Blood Pressure for Household Members | 6 months and 12 months | Blood pressure as available in EHR records |
| Outpatient Utilization for Household Members in EHR Records | 6 months and 12 months | Outpatient utilization for household members as available in EHR records |
| Inpatient Utilization for Household Members in Paid Claims | 6 months and 12 months | Inpatient utilization for household members as available in paid claims |
| Outpatient Utilization for Household Members in Paid Claims | 6 months and 12 months | Outpatient utilization for household members as available in paid claims |
| Heterogeneity: HbA1c by Baseline Level of HbA1c | 6 months and 12 months | Separate results by tercile of baseline HbA1c |
| Heterogeneity: HbA1c by Site | 6 months and 12 months | Heterogeneity analysis by site of the clinic |
| Heterogeneity: HbA1c by Causal Tree | 6 months and 12 months | Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting. |
| Inpatient Utilization for Household Members in EHR Records | 6 months and 12 months | Inpatient utilization for household members as available in EHR records |
| Triglycerides for Household Members | 6 months and 12 months | Triglycerides as available in EHR records |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group-Begin Now Group 1- Will be randomized to the treatment (Begin Now) group for the Fresh Food Farmacy program. Subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program right away when the program opens in their geographic area. Data will be collected during the first 12 months of subject participation and EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total).
Fresh Food Farmacy: Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management. | 230 |
| Control Group-Begin Later Group 2- Will be randomized to the control (Begin Later) group for the FFF program. These subjects will be consented to join the FFF study prior to learning their program start date. They will join the FFF program approximately 6 months after the program opens in their geographic area. Data will be collected during the first 6 months of subject participation and used as control data for the study. EHR and claims data may be analyzed for an additional 12 month follow-up period (24 months in total from the start of the trial). | 235 |
| Total | 465 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 6-month HbA1c Sample | Lost to Follow-up | 60 | 56 |
| Analysis Sample | Legal hold on data | 1 | 0 |
| Analysis Sample | Participant from treated household | 0 | 1 |
| Analysis Sample | Withdrawal by Subject | 18 | 15 |
Baseline characteristics
| Characteristic | Total | Treatment Group-Begin Now | Control Group-Begin Later |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 11.8 | 54.8 years STANDARD_DEVIATION 11.3 | 54.4 years STANDARD_DEVIATION 12.4 |
| Clinic location Rural | 131 Participants | 64 Participants | 67 Participants |
| Clinic location Urban | 334 Participants | 166 Participants | 168 Participants |
| Prior-year healthcare use Any emergency department visit | 191 Participants | 97 Participants | 94 Participants |
| Prior-year healthcare use Any inpatient admission | 107 Participants | 59 Participants | 48 Participants |
| Race/Ethnicity, Customized Hispanic (any race) | 39 Participants | 16 Participants | 23 Participants |
| Race/Ethnicity, Customized Non-Hispanic and other race | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 41 Participants | 23 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 378 Participants | 189 Participants | 189 Participants |
| Region of Enrollment United States | 465 Participants | 230 Participants | 235 Participants |
| Sex: Female, Male Female | 255 Participants | 130 Participants | 125 Participants |
| Sex: Female, Male Male | 210 Participants | 100 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 249 | 0 / 251 |
| other Total, other adverse events | 0 / 249 | 0 / 251 |
| serious Total, serious adverse events | 0 / 249 | 0 / 251 |
Outcome results
Primary
HbA1c
Glycated hemoglobin (HbA1c) is a measure of the average share of glucose that has been in the bloodstream over the 2-3 months preceding measurement. HbA1c is measured by performing assays on samples of the participants' blood. Units are percentages; for differences between HbA1c values, units are percentage points. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.
Time frame: 6 months after trial enrollment
Population: Participants from the 465-person analysis sample who completed an HbA1c blood test between 5 and 10 months after program enrollment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group-Begin Now | HbA1c | 8.781177 % of hemoglobin | Standard Deviation 1.643995 |
| Control Group-Begin Later | HbA1c | 8.814526 % of hemoglobin | Standard Deviation 1.978937 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.863868895% CI: [-0.415628, 0.3489306]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.971457195% CI: [-0.371329, 0.358052]Regression, Linear
Secondary
Body Mass Index
Body Mass Index (BMI) in kg/m\^2. BMI is computed using weight (lb) and height (in). The CDC's healthy reference range for BMI among adults aged 20 and older is 18.5 to 24.9. BMI values greater than or equal to 30.0 indicate obesity. In the context of this study, higher BMI is considered a worse outcome.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants whose weight was recorded between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Body Mass Index | 6 months after trial enrollment | 36.77117 kg/m^2 | Standard Deviation 8.615884 |
| Treatment Group-Begin Now | Body Mass Index | 12 months after trial enrollment | 36.20175 kg/m^2 | Standard Deviation 8.299285 |
| Control Group-Begin Later | Body Mass Index | 6 months after trial enrollment | 37.6461 kg/m^2 | Standard Deviation 10.06821 |
| Control Group-Begin Later | Body Mass Index | 12 months after trial enrollment | 37.65195 kg/m^2 | Standard Deviation 9.895644 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.350231395% CI: [-2.714084, 0.9642311]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.039079795% CI: [0.0282451, 1.093399]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.128103295% CI: [-3.320109, 0.419716]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.304473295% CI: [-0.2549974, 0.8139224]Regression, Linear
Secondary
Diastolic Blood Pressure
Diastolic blood pressure, measured in mm Hg. The American College of Cardiology identifies normal diastolic blood pressure as below 80 mm Hg and elevated/hypertensive diastolic blood pressure as 80 mm Hg or above. Higher levels of diastolic blood pressure indicate worse outcomes.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who had their blood pressure recorded between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Diastolic Blood Pressure | 6 months after trial enrollment | 74.2043 mm Hg | Standard Deviation 10.71504 |
| Treatment Group-Begin Now | Diastolic Blood Pressure | 12 months after trial enrollment | 74.48235 mm Hg | Standard Deviation 9.271847 |
| Control Group-Begin Later | Diastolic Blood Pressure | 6 months after trial enrollment | 74.76041 mm Hg | Standard Deviation 10.40413 |
| Control Group-Begin Later | Diastolic Blood Pressure | 12 months after trial enrollment | 73.98343 mm Hg | Standard Deviation 10.46395 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.609147795% CI: [-2.693002, 1.58077]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.71394295% CI: [-2.409379, 1.651786]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.636206495% CI: [-1.573807, 2.571662]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.274888495% CI: [-0.9154561, 3.208027]Regression, Linear
Secondary
Engagement Index Score
Survey-based index score for patient-reported positive engagement outcomes. Scores range from 0 to 1. Scores are standardized so that the control group always has a mean score of 0 and standard deviation of 1. Higher scores reflect better outcomes---here, better engagement with the program. Scores composite results from multiple survey questions while adjusting for covariance between questions.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Engagement Index Score | 6 months after trial enrollment | 0.4018523 score on a scale | Standard Deviation 0.8282961 |
| Treatment Group-Begin Now | Engagement Index Score | 12 months after trial enrollment | 0.000623 score on a scale | Standard Deviation 0.8280342 |
| Control Group-Begin Later | Engagement Index Score | 6 months after trial enrollment | 0 score on a scale | Standard Deviation 1 |
| Control Group-Begin Later | Engagement Index Score | 12 months after trial enrollment | 0 score on a scale | Standard Deviation 1 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.000074395% CI: [0.2048311, 0.5988733]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.000447195% CI: [0.16227, 0.566349]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.995468395% CI: [-0.2150785, 0.2163243]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.885226895% CI: [-0.2357129, 0.2034834]Regression, Linear
Secondary
Fasting Glucose
Fasting blood glucose is a measure of blood sugar control over a short time period (the blood glucose content after an overnight fast). Units are mg/dL. To convert to mmol/L (SI), multiply by 0.0113. Lower fasting blood glucose levels indicate better health within the context of this study.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Fasting Glucose | 6 months after trial enrollment | 185.0236 mg/dL | Standard Deviation 76.36467 |
| Treatment Group-Begin Now | Fasting Glucose | 12 months after trial enrollment | 185.4696 mg/dL | Standard Deviation 68.86821 |
| Control Group-Begin Later | Fasting Glucose | 12 months after trial enrollment | 172.3441 mg/dL | Standard Deviation 68.18301 |
| Control Group-Begin Later | Fasting Glucose | 6 months after trial enrollment | 198.292 mg/dL | Standard Deviation 99.97935 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.224742695% CI: [-34.73804, 8.201347]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.279401595% CI: [-34.37119, 9.9679]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.170832895% CI: [-5.703702, 31.95466]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.280113895% CI: [-9.422762, 32.3743]Regression, Linear
Secondary
HbA1c
Glycated hemoglobin. Units are percentages (for differences, percentage points) reflecting the average share of glucose in the bloodstream over the previous 2-3 months. An HbA1c value of 6.5% is the lower threshold for type 2 diabetes. HbA1c values are rarely above 15-20%. In the context of this study (patients with type 2 diabetes), higher scores are considered a worse outcome.
Time frame: 12 months after trial enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group-Begin Now | HbA1c | 8.735975 % of hemoglobin | Standard Deviation 1.748229 |
| Control Group-Begin Later | HbA1c | 8.595031 % of hemoglobin | Standard Deviation 2.035983 |
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.503956595% CI: [-0.2735162, 0.5554053]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.568485495% CI: [-0.2970052, 0.5397882]Regression, Linear
Secondary
HDL Cholesterol
High-density lipoprotein (HDL) cholesterol, measured in mg/dL. The CDC recommends HDL levels of at least 40 mg/dL in men and 50 mg/dL in women. In the context of this study, higher levels of HDL indicate a better outcome. SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0259.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | HDL Cholesterol | 6 months after trial enrollment | 41.27718 mg/dL | Standard Deviation 12.98269 |
| Treatment Group-Begin Now | HDL Cholesterol | 12 months after trial enrollment | 42.34722 mg/dL | Standard Deviation 12.73743 |
| Control Group-Begin Later | HDL Cholesterol | 6 months after trial enrollment | 41.8323 mg/dL | Standard Deviation 12.08006 |
| Control Group-Begin Later | HDL Cholesterol | 12 months after trial enrollment | 43.73333 mg/dL | Standard Deviation 17.07761 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.697621695% CI: [-3.363839, 2.253605]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.632903595% CI: [-2.546815, 1.551216]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.44518195% CI: [-4.954999, 2.182777]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.554224195% CI: [-4.765783, 2.561956]Regression, Linear
Secondary
Inpatient and Emergency Department Payments
Healthcare utilization: Total value (USD) of inpatient and emergency department payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Inpatient and Emergency Department Payments | 6 months after trial enrollment | 2175.39 USD | Standard Deviation 6176.236 |
| Treatment Group-Begin Now | Inpatient and Emergency Department Payments | 12 months after trial enrollment | 3284.667 USD | Standard Deviation 7850.193 |
| Control Group-Begin Later | Inpatient and Emergency Department Payments | 6 months after trial enrollment | 2161.593 USD | Standard Deviation 5284.944 |
| Control Group-Begin Later | Inpatient and Emergency Department Payments | 12 months after trial enrollment | 4545.119 USD | Standard Deviation 9951.439 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.986408195% CI: [-1581.244, 1608.838]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.892913395% CI: [-1627.128, 1865.789]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.34372495% CI: [-3880.298, 1359.393]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.370965495% CI: [-3860.887, 1448.455]Regression, Linear
Secondary
LDL Cholesterol
Low-density lipoprotein (LDL) cholesterol, measured in mg/dL. The CDC recommends LDL levels of 100 mg/dL or below. In the context of this study, higher levels of LDL indicate a worse outcome. SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | LDL Cholesterol | 12 months after trial enrollment | 87.36268 mg/dL | Standard Deviation 36.73616 |
| Treatment Group-Begin Now | LDL Cholesterol | 6 months after trial enrollment | 93.54835 mg/dL | Standard Deviation 44.67019 |
| Control Group-Begin Later | LDL Cholesterol | 6 months after trial enrollment | 85.19621 mg/dL | Standard Deviation 36.72769 |
| Control Group-Begin Later | LDL Cholesterol | 12 months after trial enrollment | 84.72519 mg/dL | Standard Deviation 36.62367 |
Comparison: Unadjusted mean difference, 6 months after trial enrollment.p-value: 0.074306295% CI: [-0.8250086, 17.52929]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.127065495% CI: [-1.709219, 13.65159]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.55327795% CI: [-6.110146, 11.38512]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.51956295% CI: [-5.198658, 10.26164]Regression, Linear
Secondary
Mean Proportion of Diabetes Knowledge Questions Answered Correctly
The proportion of questions testing patients' knowledge of how different factors contribute to blood sugar answered correctly.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Mean Proportion of Diabetes Knowledge Questions Answered Correctly | 6 months after trial enrollment | 0.8267857 proportion of questions | Standard Deviation 0.1489169 |
| Treatment Group-Begin Now | Mean Proportion of Diabetes Knowledge Questions Answered Correctly | 12 months after trial enrollment | 0.8271728 proportion of questions | Standard Deviation 0.1416987 |
| Control Group-Begin Later | Mean Proportion of Diabetes Knowledge Questions Answered Correctly | 6 months after trial enrollment | 0.7756302 proportion of questions | Standard Deviation 0.1472909 |
| Control Group-Begin Later | Mean Proportion of Diabetes Knowledge Questions Answered Correctly | 12 months after trial enrollment | 0.8133472 proportion of questions | Standard Deviation 0.1444886 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.001872195% CI: [0.0190582, 0.0832528]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.010623195% CI: [0.0101555, 0.0764607]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.419789895% CI: [-0.0198584, 0.0475096]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.296147995% CI: [-0.0158442, 0.0518147]Regression, Linear
Secondary
Number of Diabetes Self-Management Trainings Completed
The number of times an individual participant completed a Diabetes Self-Management Training (DSMT) in the relevant time frame, based on electronic health records.
Time frame: 6 and 12 months after trial enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Number of Diabetes Self-Management Trainings Completed | 6 months after trial enrollment | 2.243478 number of trainings | Standard Deviation 1.439258 |
| Treatment Group-Begin Now | Number of Diabetes Self-Management Trainings Completed | 12 months after trial enrollment | 3.791304 number of trainings | Standard Deviation 2.498893 |
| Control Group-Begin Later | Number of Diabetes Self-Management Trainings Completed | 12 months after trial enrollment | 2.140425 number of trainings | Standard Deviation 1.888297 |
| Control Group-Begin Later | Number of Diabetes Self-Management Trainings Completed | 6 months after trial enrollment | 0.3617021 number of trainings | Standard Deviation 0.7168763 |
Comparison: Unadjusted mean difference, 6 months after trial enrollment.p-value: <0.00195% CI: [1.673875, 2.089677]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollment.p-value: <0.00195% CI: [1.664499, 2.071943]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollment.p-value: <0.00195% CI: [1.246611, 2.055147]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollment.p-value: <0.00195% CI: [1.232994, 2.039618]Regression, Linear
Secondary
Number of Inpatient and Emergency Department Visits Claimed by Insurance
Healthcare utilization: Number of inpatient and emergency department claims among continuously enrolled/insured subjects during the relevant time frame after enrollment.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Number of Inpatient and Emergency Department Visits Claimed by Insurance | 6 months after trial enrollment | 0.6869565 Number of claims | Standard Deviation 1.363051 |
| Treatment Group-Begin Now | Number of Inpatient and Emergency Department Visits Claimed by Insurance | 12 months after trial enrollment | 1.221739 Number of claims | Standard Deviation 2.116365 |
| Control Group-Begin Later | Number of Inpatient and Emergency Department Visits Claimed by Insurance | 6 months after trial enrollment | 0.7914894 Number of claims | Standard Deviation 1.680434 |
| Control Group-Begin Later | Number of Inpatient and Emergency Department Visits Claimed by Insurance | 12 months after trial enrollment | 1.497872 Number of claims | Standard Deviation 3.350436 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.461240895% CI: [-0.3830955, 0.1740299]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.640186495% CI: [-0.2874987, 0.176954]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.287491395% CI: [-0.7857084, 0.2334419]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.456860195% CI: [-0.56713, 0.2554439]Regression, Linear
Secondary
Number of Outpatient Visits Claimed by Insurance
Healthcare utilization: Number of outpatient claims among continuously enrolled/insured subjects during the relevant time frame after trial enrollment.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Number of Outpatient Visits Claimed by Insurance | 6 months after trial enrollment | 5.765217 Number of claims | Standard Deviation 4.884394 |
| Treatment Group-Begin Now | Number of Outpatient Visits Claimed by Insurance | 12 months after trial enrollment | 10.1 Number of claims | Standard Deviation 8.088674 |
| Control Group-Begin Later | Number of Outpatient Visits Claimed by Insurance | 12 months after trial enrollment | 10.07234 Number of claims | Standard Deviation 8.314793 |
| Control Group-Begin Later | Number of Outpatient Visits Claimed by Insurance | 6 months after trial enrollment | 4.86383 Number of claims | Standard Deviation 4.628804 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.041741395% CI: [0.0338441, 1.768931]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.022222295% CI: [0.1282798, 1.65967]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.971010395% CI: [-1.467185, 1.522504]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.953911795% CI: [-1.244338, 1.319787]Regression, Linear
Secondary
Number of Visits to a Dietician
The number of times an individual participant completed a medical appointment with a dietician in the relevant time frame, based on electronic health records.
Time frame: 6 and 12 months after trial enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Number of Visits to a Dietician | 6 months after trial enrollment | 2.656522 number of visits | Standard Deviation 1.745694 |
| Treatment Group-Begin Now | Number of Visits to a Dietician | 12 months after trial enrollment | 4.53913 number of visits | Standard Deviation 3.029079 |
| Control Group-Begin Later | Number of Visits to a Dietician | 6 months after trial enrollment | 0.6212766 number of visits | Standard Deviation 1.263041 |
| Control Group-Begin Later | Number of Visits to a Dietician | 12 months after trial enrollment | 2.919149 number of visits | Standard Deviation 2.701269 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: <0.00195% CI: [1.757075, 2.313415]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: <0.00195% CI: [1.734473, 2.282927]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollment.p-value: <0.00195% CI: [1.096575, 2.143388]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollment.p-value: <0.00195% CI: [1.032797, 2.086488]Regression, Linear
Secondary
Number of Visits to an Endocrinologist
The number of times an individual participant completed a medical appointment with an endocrinologist in the relevant time frame, based on electronic health records.
Time frame: 6 and 12 months after trial enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Number of Visits to an Endocrinologist | 6 months after trial enrollment | 0.5913044 number of appointments | Standard Deviation 0.8605437 |
| Treatment Group-Begin Now | Number of Visits to an Endocrinologist | 12 months after trial enrollment | 1.095652 number of appointments | Standard Deviation 1.468588 |
| Control Group-Begin Later | Number of Visits to an Endocrinologist | 6 months after trial enrollment | 0.4808511 number of appointments | Standard Deviation 0.7970668 |
| Control Group-Begin Later | Number of Visits to an Endocrinologist | 12 months after trial enrollment | 0.8893617 number of appointments | Standard Deviation 1.302731 |
Comparison: Unadjusted mean difference, 6 months after trial enrollment.p-value: 0.151915395% CI: [-0.040785, 0.2616915]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollment.p-value: 0.364125495% CI: [-0.0691675, 0.1880824]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollment.p-value: 0.110018695% CI: [-0.0468859, 0.4594669]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollment.p-value: 0.253130395% CI: [-0.0834025, 0.3158775]Regression, Linear
Secondary
Number of Weight Loss and Weight Management Appointments Completed
The number of times an individual participant completed a medical appointment regarding weight loss or weight management in the relevant time frame, based on electronic health records.
Time frame: 6 and 12 months after trial enrollment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Number of Weight Loss and Weight Management Appointments Completed | 6 months after trial enrollment | 0.0521739 number of appointments | Standard Error 0.3457409 |
| Treatment Group-Begin Now | Number of Weight Loss and Weight Management Appointments Completed | 12 months after trial enrollment | 0.0521739 number of appointments | Standard Error 0.3457409 |
| Control Group-Begin Later | Number of Weight Loss and Weight Management Appointments Completed | 6 months after trial enrollment | 0.1106383 number of appointments | Standard Error 0.5193825 |
| Control Group-Begin Later | Number of Weight Loss and Weight Management Appointments Completed | 12 months after trial enrollment | 0.2212766 number of appointments | Standard Error 0.9707113 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.15291895% CI: [-0.1387132, 0.0217844]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollment.p-value: 0.054834495% CI: [-0.1183728, 0.0012186]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollment.p-value: 0.012323895% CI: [-0.3013583, -0.036847]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollment.p-value: 0.003253495% CI: [-0.2831584, -0.0571266]Regression, Linear
Secondary
Outpatient Payments
Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Outpatient Payments | 6 months after trial enrollment | 3313.627 USD | Standard Deviation 6553.01 |
| Treatment Group-Begin Now | Outpatient Payments | 12 months after trial enrollment | 5327.305 USD | Standard Deviation 7561.854 |
| Control Group-Begin Later | Outpatient Payments | 6 months after trial enrollment | 2023.022 USD | Standard Deviation 3492.728 |
| Control Group-Begin Later | Outpatient Payments | 12 months after trial enrollment | 4117.954 USD | Standard Deviation 5205.939 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.079508795% CI: [-153.3215, 2734.532]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.168978695% CI: [-517.7854, 2933.309]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.208014595% CI: [-679.1596, 3097.86]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.244590495% CI: [-869.3893, 3386.563]Regression, Linear
Secondary
Participants Answering Yes for Diet Improvement Compared to One Year Ago
Patient-reported measure of diet improvement: Survey question: Do you believe your diet has improved compared to one year ago?.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group-Begin Now | Participants Answering Yes for Diet Improvement Compared to One Year Ago | 12 months after trial enrollment | 137 Participants |
| Treatment Group-Begin Now | Participants Answering Yes for Diet Improvement Compared to One Year Ago | 6 months after trial enrollment | 153 Participants |
| Control Group-Begin Later | Participants Answering Yes for Diet Improvement Compared to One Year Ago | 12 months after trial enrollment | 129 Participants |
| Control Group-Begin Later | Participants Answering Yes for Diet Improvement Compared to One Year Ago | 6 months after trial enrollment | 132 Participants |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.000025295% CI: [0.0868814, 0.2351126]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.000020495% CI: [0.0922183, 0.2461232]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.913081695% CI: [-0.0486635, 0.0543825]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.540005395% CI: [-0.0367394, 0.0700045]Regression, Linear
Secondary
Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance
The number of subjects who were continuously enrolled/insured who had any inpatient or emergency department claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group-Begin Now | Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance | 6 months after trial enrollment | 70 Participants |
| Treatment Group-Begin Now | Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance | 12 months after trial enrollment | 96 Participants |
| Control Group-Begin Later | Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance | 12 months after trial enrollment | 110 Participants |
| Control Group-Begin Later | Proportion of Participants Filing Inpatient or Emergency Department Claims With Insurance | 6 months after trial enrollment | 84 Participants |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.224516795% CI: [-0.1388926, 0.0326946]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.055191395% CI: [-0.1650069, 0.0018204]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.272137395% CI: [-0.1413002, 0.0399126]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.064007195% CI: [-0.1637776, 0.0046516]Regression, Linear
Secondary
Proportion of Participants Filing Outpatient Insurance Claims With Insurance
The number of subjects who were continuously enrolled/insured who had any outpatient claims during the relevant time frame after trial enrollment. For statistical analyses, coefficients and errors represent proportions of participants, relative to the size of the group/treatment arm.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed may differ due to differences in the number of participants who remained continuously enrolled in the health plan between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Group-Begin Now | Proportion of Participants Filing Outpatient Insurance Claims With Insurance | 6 months after trial enrollment | 215 Participants |
| Treatment Group-Begin Now | Proportion of Participants Filing Outpatient Insurance Claims With Insurance | 12 months after trial enrollment | 221 Participants |
| Control Group-Begin Later | Proportion of Participants Filing Outpatient Insurance Claims With Insurance | 6 months after trial enrollment | 207 Participants |
| Control Group-Begin Later | Proportion of Participants Filing Outpatient Insurance Claims With Insurance | 12 months after trial enrollment | 224 Participants |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.044241895% CI: [0.0013953, 0.1064678]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.045485795% CI: [0.0011025, 0.1082124]Regression, Linear
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.68376495% CI: [-0.0293401, 0.0446963]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.770885295% CI: [-0.0306419, 0.0413103]Regression, Linear
Secondary
Systolic Blood Pressure
Systolic blood pressure, measured in mm Hg. The CDC identifies normal healthy systolic blood pressure as below 120 mm Hg. The American College of Cardiology identifies 120 to 129 mm Hg as elevated blood pressure and 130 mm Hg and higher as hypertensive. Higher systolic blood pressure levels indicate worse outcomes.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who had their blood pressure recorded between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Systolic Blood Pressure | 6 months after trial enrollment | 128.3118 mm Hg | Standard Deviation 19.06545 |
| Treatment Group-Begin Now | Systolic Blood Pressure | 12 months after trial enrollment | 126.0235 mm Hg | Standard Deviation 17.24071 |
| Control Group-Begin Later | Systolic Blood Pressure | 12 months after trial enrollment | 129.7956 mm Hg | Standard Deviation 18.45165 |
| Control Group-Begin Later | Systolic Blood Pressure | 6 months after trial enrollment | 130.1823 mm Hg | Standard Deviation 20.29064 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.35612395% CI: [-5.851219, 2.110291]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.656649495% CI: [-4.681041, 2.95376]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.048494495% CI: [-7.519021, -0.0250809]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.23494795% CI: [-5.749627, 1.415558]Regression, Linear
Secondary
Times Drinking Sweetened Beverages in the Past 7 Days
Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient drank sweetened beverages.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Times Drinking Sweetened Beverages in the Past 7 Days | 6 months after trial enrollment | 2.777778 # times | Standard Deviation 3.449728 |
| Treatment Group-Begin Now | Times Drinking Sweetened Beverages in the Past 7 Days | 12 months after trial enrollment | 2.377622 # times | Standard Deviation 3.116978 |
| Control Group-Begin Later | Times Drinking Sweetened Beverages in the Past 7 Days | 6 months after trial enrollment | 3.407186 # times | Standard Deviation 4.495186 |
| Control Group-Begin Later | Times Drinking Sweetened Beverages in the Past 7 Days | 12 months after trial enrollment | 2.550725 # times | Standard Deviation 3.60266 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.154449195% CI: [-1.496923, 0.238107]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.179348695% CI: [-1.497352, 0.2809987]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.667461895% CI: [-0.9653829, 0.6191784]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.599211395% CI: [-1.047063, 0.6054567]Regression, Linear
Secondary
Times Eating Dark Green Vegetables in the Past 7 Days
Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate dark green vegetables.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Times Eating Dark Green Vegetables in the Past 7 Days | 6 months after trial enrollment | 6.288343 # times | Standard Deviation 20.69643 |
| Treatment Group-Begin Now | Times Eating Dark Green Vegetables in the Past 7 Days | 12 months after trial enrollment | 4.202797 # times | Standard Deviation 2.378186 |
| Control Group-Begin Later | Times Eating Dark Green Vegetables in the Past 7 Days | 12 months after trial enrollment | 5.782609 # times | Standard Deviation 8.36899 |
| Control Group-Begin Later | Times Eating Dark Green Vegetables in the Past 7 Days | 6 months after trial enrollment | 4.011765 # times | Standard Deviation 2.9007 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.165034395% CI: [-0.9420086, 5.495166]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.144212695% CI: [-0.6843682, 4.663284]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollment.p-value: 0.033549895% CI: [-3.03574, -0.1238828]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.039893795% CI: [-3.447175, -0.0820899]Regression, Linear
Secondary
Times Eating Fruit in the Past 7 Days
Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fruit.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Times Eating Fruit in the Past 7 Days | 6 months after trial enrollment | 5.564417 # times | Standard Deviation 3.344494 |
| Treatment Group-Begin Now | Times Eating Fruit in the Past 7 Days | 12 months after trial enrollment | 5.097222 # times | Standard Deviation 2.377986 |
| Control Group-Begin Later | Times Eating Fruit in the Past 7 Days | 6 months after trial enrollment | 5.241177 # times | Standard Deviation 3.397799 |
| Control Group-Begin Later | Times Eating Fruit in the Past 7 Days | 12 months after trial enrollment | 5.79562 # times | Standard Deviation 3.343428 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.382322495% CI: [-0.4036366, 1.050118]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.482933995% CI: [-0.4718566, 0.9958495]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.04550695% CI: [-1.382737, -0.0140597]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.062555195% CI: [-1.280906, 0.0329412]Regression, Linear
Secondary
Times Eating Out in the Past 7 Days
Patient-reported measure of diet improvement: Number of times in the last 7 days when the patient ate fast food, takeout, or at a restaurant.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Times Eating Out in the Past 7 Days | 6 months after trial enrollment | 4.5 # times | Standard Deviation 3.948285 |
| Treatment Group-Begin Now | Times Eating Out in the Past 7 Days | 12 months after trial enrollment | 4.402778 # times | Standard Deviation 3.956617 |
| Control Group-Begin Later | Times Eating Out in the Past 7 Days | 6 months after trial enrollment | 4.017544 # times | Standard Deviation 3.78771 |
| Control Group-Begin Later | Times Eating Out in the Past 7 Days | 12 months after trial enrollment | 4.413043 # times | Standard Deviation 3.927682 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.254903795% CI: [-0.349686, 1.314598]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.402597795% CI: [-0.4777863, 1.186949]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.982573995% CI: [-0.9346107, 0.9140792]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.944360795% CI: [-0.9928399, 0.9248032]Regression, Linear
Secondary
Total Cholesterol
Total cholesterol in mg/dL. The CDC recommends total cholesterol levels around 150 mg/dL and classifies levels of 200 mg/dL and above as unhealthy (hyperlipidemia). In the context of this study, higher total cholesterol indicates a worse outcome. SI conversion factor: To convert from mg/dL to mmol/L, multiply by 0.0259.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Total Cholesterol | 12 months after trial enrollment | 164.8345 mg/dL | Standard Deviation 50.04346 |
| Treatment Group-Begin Now | Total Cholesterol | 6 months after trial enrollment | 170.3087 mg/dL | Standard Deviation 55.49542 |
| Control Group-Begin Later | Total Cholesterol | 6 months after trial enrollment | 160.5404 mg/dL | Standard Deviation 48.39021 |
| Control Group-Begin Later | Total Cholesterol | 12 months after trial enrollment | 165.3806 mg/dL | Standard Deviation 56.96481 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.100746395% CI: [-1.907847, 21.44455]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.385986895% CI: [-5.66534, 14.60935]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.932490895% CI: [-13.22545, 12.13323]Regression, Linear
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.632807595% CI: [-14.08487, 8.579205]Regression, Linear
Secondary
Triglycerides
Triglycerides, measured in mg/dL. The CDC recommends levels of triglycerides below 150 mg/dL. In the context of this study, higher levels of triglycerides indicate worse outcomes. SI conversion factor: To convert mg/dL to mmol/L, multiply by 0.0113.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who completed blood tests including cholesterol measurements between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Triglycerides | 12 months after trial enrollment | 212.7762 mg/dL | Standard Deviation 153.4214 |
| Treatment Group-Begin Now | Triglycerides | 6 months after trial enrollment | 223.5705 mg/dL | Standard Deviation 155.5674 |
| Control Group-Begin Later | Triglycerides | 12 months after trial enrollment | 224.1288 mg/dL | Standard Deviation 268.9378 |
| Control Group-Begin Later | Triglycerides | 6 months after trial enrollment | 201.0123 mg/dL | Standard Deviation 157.1144 |
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.204534895% CI: [-12.35316, 57.4694]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.367525295% CI: [-15.93658, 42.9322]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.670930795% CI: [-63.8992, 41.19407]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.676684495% CI: [-50.95358, 33.12859]Regression, Linear
Secondary
Weight (lb)
Weight in pounds. In the context of this study, higher values are considered a worse outcome. SI conversion factor: To convert pounds to kilograms, multiply by 0.4536.
Time frame: 6 and 12 months after trial enrollment
Population: Number of participants analyzed differs due to differences in the number of participants who had their weight recorded between 6 and 12 months after trial enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group-Begin Now | Weight (lb) | 6 months after trial enrollment | 230.8205 pounds (lb) | Standard Deviation 60.13527 |
| Treatment Group-Begin Now | Weight (lb) | 12 months after trial enrollment | 227.9171 pounds (lb) | Standard Deviation 58.1217 |
| Control Group-Begin Later | Weight (lb) | 6 months after trial enrollment | 238.9561 pounds (lb) | Standard Deviation 66.3286 |
| Control Group-Begin Later | Weight (lb) | 12 months after trial enrollment | 237.5989 pounds (lb) | Standard Deviation 63.47953 |
Comparison: Adjusted mean difference for full controls, 12 months after trial enrollmentp-value: 0.331855495% CI: [-1.698022, 5.014535]Regression, Linear
Comparison: Unadjusted mean difference, 6 months after trial enrollmentp-value: 0.199102895% CI: [-20.57023, 4.299061]t-test, 2 sided
Comparison: Adjusted mean difference for full controls, 6 months after trial enrollmentp-value: 0.048088495% CI: [0.0295297, 6.958066]Regression, Linear
Comparison: Unadjusted mean difference, 12 months after trial enrollmentp-value: 0.127681795% CI: [-22.15188, 2.788269]t-test, 2 sided
Other Pre-specified
Blood Pressure for Household Members
Blood pressure as available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
BMI for Household Members
BMI in kg/m\^2 in pounds as available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
Cholesterol for Household Members
Cholesterol as available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
Fasting Glucose for Household Members
Fasting glucose as available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
HbA1c for Household Members
HbA1c available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
Healthy Behaviors Observed in Electronic Health Record
Healthy behaviors observed in electronic health record, including preventive care and appointments kept
Time frame: 6 months and 12 months
Other Pre-specified
Healthy Behaviors Observed in Paid Claims HEDIS Measures
Healthy behaviors observed in paid claims using Healthcare Effectiveness Data and Information Set (HEDIS) measures. These measures were not collected for this study.
Time frame: 6 months and 12 months
Other Pre-specified
Heterogeneity: HbA1c by Baseline Level of HbA1c
Separate results by tercile of baseline HbA1c
Time frame: 6 months and 12 months
Other Pre-specified
Heterogeneity: HbA1c by Causal Tree
Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting.
Time frame: 6 months and 12 months
Other Pre-specified
Heterogeneity: HbA1c by Site
Heterogeneity analysis by site of the clinic
Time frame: 6 months and 12 months
Other Pre-specified
Inpatient Utilization for Household Members in EHR Records
Inpatient utilization for household members as available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
Inpatient Utilization for Household Members in Paid Claims
Inpatient utilization for household members as available in paid claims
Time frame: 6 months and 12 months
Other Pre-specified
Outpatient Utilization for Household Members in EHR Records
Outpatient utilization for household members as available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
Outpatient Utilization for Household Members in Paid Claims
Outpatient utilization for household members as available in paid claims
Time frame: 6 months and 12 months
Other Pre-specified
Triglycerides for Household Members
Triglycerides as available in EHR records
Time frame: 6 months and 12 months
Other Pre-specified
Weight for Household Members
Weight in pounds as available in EHR records
Time frame: 6 months and 12 months