Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Massachusetts Institute of Technology | OTHER |
| Cornell University | OTHER |
| Stanford University | OTHER |
| Geisinger Clinic |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group-Begin Now | Experimental | 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). |
|
| Control Group-Begin Later | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh Food Farmacy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after trial enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after trial enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy Behaviors Observed in Electronic Health Record | Healthy behaviors observed in electronic health record, including preventive care and appointments kept | 6 months and 12 months |
| Healthy Behaviors Observed in Paid Claims HEDIS Measures |
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Bulger, MD | Geisinger Clinic | Principal Investigator |
| Joseph J Doyle | MIT Sloan School of Management | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fresh Food Farmacy | Lewistown | Pennsylvania | 17044 | United States | ||
| Fresh Food Farmacy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38147326 | Background | Doyle J, Alsan M, Skelley N, Lu Y, Cawley J. Effect of an Intensive Food-as-Medicine Program on Health and Health Care Use: A Randomized Clinical Trial. JAMA Intern Med. 2024 Feb 1;184(2):154-163. doi: 10.1001/jamainternmed.2023.6670. |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| doi:10.7910/DVN/LZUTU0 | Individual Participant Data Set | View IPD |
Deidentified data at the subject level, pending approval from the IRB and Geisinger.
Available pending approval from the IRB and after primary publication.
To be determined
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analysis Sample |
|
| |||||||||||||||||||||
| 6-month HbA1c Sample |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants from the 465-person analysis sample who completed an HbA1c blood test between 5 and 10 months after program enrollment. | Posted | Mean | Standard Deviation | % of hemoglobin | 6 months after trial enrollment |
|
18 months.
Study was deemed minimal risk by the Institutional Review Board, and study-related adverse events and unanticipated problems were tracked.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph doyle | MIT Sloan School of Management | 6174523761 | jjdoyle@mit.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2020 | Mar 4, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2019 | Apr 23, 2019 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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?". | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| Outpatient Payments | Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
| 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. | 6 and 12 months after trial enrollment |
Healthy behaviors observed in paid claims using Healthcare Effectiveness Data and Information Set (HEDIS) measures. These measures were not collected for this study.
| 6 months and 12 months |
| HbA1c for Household Members | HbA1c available in EHR records | 6 months and 12 months |
| Weight for Household Members | Weight in pounds as available in EHR records | 6 months and 12 months |
| BMI for Household Members | BMI in kg/m^2 in pounds as available in EHR records | 6 months and 12 months |
| Cholesterol for Household Members | Cholesterol as available in EHR records | 6 months and 12 months |
| Blood Pressure for Household Members | Blood pressure as available in EHR records | 6 months and 12 months |
| Triglycerides for Household Members | Triglycerides as available in EHR records | 6 months and 12 months |
| Fasting Glucose for Household Members | Fasting glucose as available in EHR records | 6 months and 12 months |
| Inpatient Utilization for Household Members in EHR Records | Inpatient utilization for household members as available in EHR records | 6 months and 12 months |
| Outpatient Utilization for Household Members in EHR Records | Outpatient utilization for household members as available in EHR records | 6 months and 12 months |
| Inpatient Utilization for Household Members in Paid Claims | Inpatient utilization for household members as available in paid claims | 6 months and 12 months |
| Outpatient Utilization for Household Members in Paid Claims | Outpatient utilization for household members as available in paid claims | 6 months and 12 months |
| Heterogeneity: HbA1c by Baseline Level of HbA1c | Separate results by tercile of baseline HbA1c | 6 months and 12 months |
| Heterogeneity: HbA1c by Site | Heterogeneity analysis by site of the clinic | 6 months and 12 months |
| Heterogeneity: HbA1c by Causal Tree | Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting. | 6 months and 12 months |
| Scranton |
| Pennsylvania |
| 18508 |
| United States |
| doi:10.7910/DVN/LZUTU0 | Analytic Code | View IPD |
| Participant from treated household |
|
| NOT COMPLETED |
|
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Prior-year healthcare use | Count of Participants | Participants |
|
| Clinic location | Count of Participants | Participants |
|
| OG001 | 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). |
|
|
|
| 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. | Posted | Mean | Standard Deviation | % of hemoglobin | 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | pounds (lb) | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | kg/m^2 | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mm Hg | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mm Hg | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment. | Posted | Mean | Standard Deviation | # times | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment. | Posted | Mean | Standard Deviation | # times | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment. | Posted | Mean | Standard Deviation | # times | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment. | Posted | Mean | Standard Deviation | # times | 6 and 12 months after trial enrollment |
|
|
|
|
| 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?". | Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment. | Posted | Count of Participants | Participants | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment. | Posted | Mean | Standard Deviation | proportion of questions | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Number of participants analyzed differs due to differences in survey (non)response between surveys completed at 6 and 12 months after trial enrollment. | Posted | Mean | Standard Deviation | score on a scale | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Number of claims | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Number of claims | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | USD | 6 and 12 months after trial enrollment |
|
|
|
|
| Secondary | Outpatient Payments | Healthcare utilization: Value (USD) of outpatient payments among continuously enrolled/insured subjects during the relevant time frame after enrollment. | 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. | Posted | Mean | Standard Deviation | USD | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | number of visits | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | number of trainings | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | number of appointments | 6 and 12 months after trial enrollment |
|
|
|
|
| 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. | Posted | Mean | Standard Error | number of appointments | 6 and 12 months after trial enrollment |
|
|
|
|
| Other Pre-specified | Healthy Behaviors Observed in Electronic Health Record | Healthy behaviors observed in electronic health record, including preventive care and appointments kept | Not Posted | Jan 2027 | 6 months and 12 months | Participants |
| 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. | Not Posted | Jan 2027 | 6 months and 12 months | Participants |
| Other Pre-specified | HbA1c for Household Members | HbA1c available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Weight for Household Members | Weight in pounds as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | BMI for Household Members | BMI in kg/m^2 in pounds as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Cholesterol for Household Members | Cholesterol as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Blood Pressure for Household Members | Blood pressure as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Triglycerides for Household Members | Triglycerides as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Fasting Glucose for Household Members | Fasting glucose as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Inpatient Utilization for Household Members in EHR Records | Inpatient utilization for household members as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Outpatient Utilization for Household Members in EHR Records | Outpatient utilization for household members as available in EHR records | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Inpatient Utilization for Household Members in Paid Claims | Inpatient utilization for household members as available in paid claims | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Outpatient Utilization for Household Members in Paid Claims | Outpatient utilization for household members as available in paid claims | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Heterogeneity: HbA1c by Baseline Level of HbA1c | Separate results by tercile of baseline HbA1c | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Heterogeneity: HbA1c by Site | Heterogeneity analysis by site of the clinic | Not Posted | 6 months and 12 months | Participants |
| Other Pre-specified | Heterogeneity: HbA1c by Causal Tree | Heterogeneity analysis by causal trees using the baseline characteristics to explore heterogeneity, sample size permitting. | Not Posted | 6 months and 12 months | Participants |
| 0 |
| 249 |
| 0 |
| 249 |
| 0 |
| 249 |
| EG001 | 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). | 0 | 251 | 0 | 251 | 0 | 251 |
Not provided
Not provided
Adjusted mean difference for full controls, 12 months after trial enrollment |
| Regression, Linear |
| 0.5684854 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.1213915 |
| Standard Error of the Mean |
| 0.2126328 |
| 2-Sided |
| 95 |
| -0.2970052 |
| 0.5397882 |
| Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.2794015 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -12.20164 |
| Standard Error of the Mean |
| 11.25555 |
| 2-Sided |
| 95 |
| -34.37119 |
| 9.9679 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.1708328 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 13.12548 | Standard Error of the Mean | 9.550462 | 2-Sided | 95 | -5.703702 | 31.95466 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.2801138 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 11.47577 | Standard Error of the Mean | 10.59479 | 2-Sided | 95 | -9.422762 | 32.3743 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0480884 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 3.493798 |
| Standard Error of the Mean |
| 1.761916 |
| 2-Sided |
| 95 |
| 0.0295297 |
| 6.958066 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.1276817 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -9.681804 | Standard Error of the Mean | 6.34136 | 2-Sided | 95 | -22.15188 | 2.788269 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.3318554 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1.658257 | Standard Error of the Mean | 1.706497 | 2-Sided | 95 | -1.698022 | 5.014535 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0390797 |
Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.5608222 |
| Standard Error of the Mean |
| 0.2708671 |
| 2-Sided |
| 95 |
| 0.0282451 |
| 1.093399 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.1281032 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -1.450197 | Standard Error of the Mean | 0.9508997 | 2-Sided | 95 | -3.320109 | 0.419716 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.3044732 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.2794625 | Standard Error of the Mean | 0.2717457 | 2-Sided | 95 | -0.2549974 | 0.8139224 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.3859868 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 4.472004 |
| Standard Error of the Mean |
| 5.150772 |
| 2-Sided |
| 95 |
| -5.66534 |
| 14.60935 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | Regression, Linear | 0.9324908 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.5461143 | Standard Error of the Mean | 6.440905 | 2-Sided | 95 | -13.22545 | 12.13323 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.6328075 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -2.752831 | Standard Error of the Mean | 5.754947 | 2-Sided | 95 | -14.08487 | 8.579205 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.1270654 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 5.971188 |
| Standard Error of the Mean |
| 3.902349 |
| 2-Sided |
| 95 |
| -1.709219 |
| 13.65159 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.553277 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 2.637485 | Standard Error of the Mean | 4.443227 | 2-Sided | 95 | -6.110146 | 11.38512 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.519562 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 2.53149 | Standard Error of the Mean | 3.925307 | 2-Sided | 95 | -5.198658 | 10.26164 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.6329035 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -0.4977997 |
| Standard Error of the Mean |
| 1.041102 |
| 2-Sided |
| 95 |
| -2.546815 |
| 1.551216 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.445181 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -1.386111 | Standard Error of the Mean | 1.812939 | 2-Sided | 95 | -4.954999 | 2.182777 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.5542241 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -1.101914 | Standard Error of the Mean | 1.860687 | 2-Sided | 95 | -4.765783 | 2.561956 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.3675252 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 13.49781 |
| Standard Error of the Mean |
| 14.95579 |
| 2-Sided |
| 95 |
| -15.93658 |
| 42.9322 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.6709307 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -11.35256 | Standard Error of the Mean | 26.69115 | 2-Sided | 95 | -63.8992 | 41.19407 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.6766844 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -8.912496 | Standard Error of the Mean | 21.34891 | 2-Sided | 95 | -50.95358 | 33.12859 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.6566494 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -0.8636408 |
| Standard Error of the Mean |
| 1.941141 |
| 2-Sided |
| 95 |
| -4.681041 |
| 2.95376 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.0484944 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -3.772051 | Standard Error of the Mean | 1.905125 | 2-Sided | 95 | -7.519021 | -0.0250809 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.234947 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -2.167034 | Standard Error of the Mean | 1.821244 | 2-Sided | 95 | -5.749627 | 1.415558 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.713942 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -0.3787962 |
| Standard Error of the Mean |
| 1.032547 |
| 2-Sided |
| 95 |
| -2.409379 |
| 1.651786 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.6362064 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.4989275 | Standard Error of the Mean | 1.053869 | 2-Sided | 95 | -1.573807 | 2.571662 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.2748884 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1.146286 | Standard Error of the Mean | 1.048105 | 2-Sided | 95 | -0.9154561 | 3.208027 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.4829339 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.2619965 |
| Standard Error of the Mean |
| 0.3729922 |
| 2-Sided |
| 95 |
| -0.4718566 |
| 0.9958495 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.045506 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.6983982 | Standard Error of the Mean | 0.3476441 | 2-Sided | 95 | -1.382737 | -0.0140597 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.0625551 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.6239824 | Standard Error of the Mean | 0.3336405 | 2-Sided | 95 | -1.280906 | 0.0329412 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.1442126 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 1.989458 |
| Standard Error of the Mean |
| 1.359013 |
| 2-Sided |
| 95 |
| -0.6843682 |
| 4.663284 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment. | t-test, 2 sided | 0.0335498 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -1.579811 | Standard Error of the Mean | 0.739612 | 2-Sided | 95 | -3.03574 | -0.1238828 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.0398937 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -1.764632 | Standard Error of the Mean | 0.8545352 | 2-Sided | 95 | -3.447175 | -0.0820899 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.1793486 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -0.6081765 |
| Standard Error of the Mean |
| 0.451915 |
| 2-Sided |
| 95 |
| -1.497352 |
| 0.2809987 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.6674618 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.1731023 | Standard Error of the Mean | 0.4024787 | 2-Sided | 95 | -0.9653829 | 0.6191784 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.5992113 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.2208031 | Standard Error of the Mean | 0.4196435 | 2-Sided | 95 | -1.047063 | 0.6054567 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.4025977 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.3545817 |
| Standard Error of the Mean |
| 0.4230741 |
| 2-Sided |
| 95 |
| -0.4777863 |
| 1.186949 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.9825739 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.0102657 | Standard Error of the Mean | 0.4695747 | 2-Sided | 95 | -0.9346107 | 0.9140792 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.9443607 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.0340184 | Standard Error of the Mean | 0.4869778 | 2-Sided | 95 | -0.9928399 | 0.9248032 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0000204 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.1691707 |
| Standard Error of the Mean |
| 0.0391132 |
| 2-Sided |
| 95 |
| 0.0922183 |
| 0.2461232 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.9130816 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0028595 | Standard Error of the Mean | 0.0261733 | 2-Sided | 95 | -0.0486635 | 0.0543825 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.5400053 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0166325 | Standard Error of the Mean | 0.0271062 | 2-Sided | 95 | -0.0367394 | 0.0700045 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0106231 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.0433081 |
| Standard Error of the Mean |
| 0.0168497 |
| 2-Sided |
| 95 |
| 0.0101555 |
| 0.0764607 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.4197898 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0138256 | Standard Error of the Mean | 0.0171112 | 2-Sided | 95 | -0.0198584 | 0.0475096 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.2961479 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0179852 | Standard Error of the Mean | 0.0171811 | 2-Sided | 95 | -0.0158442 | 0.0518147 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0004471 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.3643095 |
| Standard Error of the Mean |
| 0.1026922 |
| 2-Sided |
| 95 |
| 0.16227 |
| 0.566349 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.9954683 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0006229 | Standard Error of the Mean | 0.1095781 | 2-Sided | 95 | -0.2150785 | 0.2163243 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.8852268 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.0161147 | Standard Error of the Mean | 0.1115322 | 2-Sided | 95 | -0.2357129 | 0.2034834 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0222222 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.8939751 |
| Standard Error of the Mean |
| 0.3896126 |
| 2-Sided |
| 95 |
| 0.1282798 |
| 1.65967 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.9710103 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0276596 | Standard Error of the Mean | 0.7606961 | 2-Sided | 95 | -1.467185 | 1.522504 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.9539117 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0377244 | Standard Error of the Mean | 0.6523585 | 2-Sided | 95 | -1.244338 | 1.319787 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.6401864 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -0.0552724 |
| Standard Error of the Mean |
| 0.1181649 |
| 2-Sided |
| 95 |
| -0.2874987 |
| 0.176954 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.2874913 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.2761332 | Standard Error of the Mean | 0.2593125 | 2-Sided | 95 | -0.7857084 | 0.2334419 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.4568601 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.155843 | Standard Error of the Mean | 0.2092772 | 2-Sided | 95 | -0.56713 | 0.2554439 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0454857 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.0546574 |
| Standard Error of the Mean |
| 0.0272506 |
| 2-Sided |
| 95 |
| 0.0011025 |
| 0.1082124 |
| Superiority |
| Unadjusted mean difference, 6 months after trial enrollment | t-test, 2 sided | 0.683764 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0076781 | Standard Error of the Mean | 0.0188378 | 2-Sided | 95 | -0.0293401 | 0.0446963 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.7708852 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.0053342 | Standard Error of the Mean | 0.0183059 | 2-Sided | 95 | -0.0306419 | 0.0413103 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.0551913 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -0.0815933 |
| Standard Error of the Mean |
| 0.0424438 |
| 2-Sided |
| 95 |
| -0.1650069 |
| 0.0018204 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.2721373 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.0506938 | Standard Error of the Mean | 0.0461078 | 2-Sided | 95 | -0.1413002 | 0.0399126 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.0640071 | Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.079563 | Standard Error of the Mean | 0.0428514 | 2-Sided | 95 | -0.1637776 | 0.0046516 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.8929133 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 119.3302 |
| Standard Error of the Mean |
| 885.2058 |
| 2-Sided |
| 95 |
| -1627.128 |
| 1865.789 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.343724 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -1260.452 | Standard Error of the Mean | 1327.743 | 2-Sided | 95 | -3880.298 | 1359.393 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.3709654 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -1206.216 | Standard Error of the Mean | 1344.574 | 2-Sided | 95 | -3860.887 | 1448.455 | Superiority |
| 12 months after trial enrollment |
|
|
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| 0.1689786 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 1207.762 |
| Standard Error of the Mean |
| 874.6068 |
| 2-Sided |
| 95 |
| -517.7854 |
| 2933.309 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment | t-test, 2 sided | 0.2080145 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1209.35 | Standard Error of the Mean | 957.1006 | 2-Sided | 95 | -679.1596 | 3097.86 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment | Regression, Linear | 0.2445904 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1258.587 | Standard Error of the Mean | 1077.807 | 2-Sided | 95 | -869.3893 | 3386.563 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment |
| Regression, Linear |
| <0.001 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 2.0087 |
| Standard Error of the Mean |
| 0.1395364 |
| 2-Sided |
| 95 |
| 1.734473 |
| 2.282927 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment. | t-test, 2 sided | <0.001 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1.619982 | Standard Error of the Mean | 0.2663507 | 2-Sided | 95 | 1.096575 | 2.143388 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment. | Regression, Linear | <0.001 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1.559642 | Standard Error of the Mean | 0.2680774 | 2-Sided | 95 | 1.032797 | 2.086488 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment. |
| Regression, Linear |
| <0.001 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 1.868221 |
| Standard Error of the Mean |
| 0.1036609 |
| 2-Sided |
| 95 |
| 1.664499 |
| 2.071943 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment. | t-test, 2 sided | <0.001 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1.650879 | Standard Error of the Mean | 0.2057239 | 2-Sided | 95 | 1.246611 | 2.055147 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment. | Regression, Linear | <0.001 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 1.636306 | Standard Error of the Mean | 0.2052192 | 2-Sided | 95 | 1.232994 | 2.039618 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment. |
| Regression, Linear |
| 0.3641254 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| 0.0594575 |
| Standard Error of the Mean |
| 0.0654489 |
| 2-Sided |
| 95 |
| -0.0691675 |
| 0.1880824 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment. | t-test, 2 sided | 0.1100186 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.2062905 | Standard Error of the Mean | 0.1288363 | 2-Sided | 95 | -0.0468859 | 0.4594669 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment. | Regression, Linear | 0.2531303 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | 0.1162375 | Standard Error of the Mean | 0.1015839 | 2-Sided | 95 | -0.0834025 | 0.3158775 | Superiority |
Adjusted mean difference for full controls, 6 months after trial enrollment. |
| Regression, Linear |
| 0.0548344 |
Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. |
| Mean Difference (Net) |
| -0.0585771 |
| Standard Error of the Mean |
| 0.0304262 |
| 2-Sided |
| 95 |
| -0.1183728 |
| 0.0012186 |
| Superiority |
| Unadjusted mean difference, 12 months after trial enrollment. | t-test, 2 sided | 0.0123238 | Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.1691027 | Standard Error of the Mean | 0.0673022 | 2-Sided | 95 | -0.3013583 | -0.036847 | Superiority |
| Adjusted mean difference for full controls, 12 months after trial enrollment. | Regression, Linear | 0.0032534 | Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors. | Mean Difference (Net) | -0.1701425 | Standard Error of the Mean | 0.0575065 | 2-Sided | 95 | -0.2831584 | -0.0571266 | Superiority |