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| Name | Class |
|---|---|
| UnitedHealth Group | INDUSTRY |
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The study team will study the efficacy of a high intensity medical weight loss intervention paired with a digital platform to create weight loss and induce remission of type 2 diabetes mellitus (T2DM) compared to a diabetes self-management education intervention. The digital platform provides the capability to tailor the treatment plan, provide automated support, and alert providers when a participant may need more support from the clinical team. If shown to be efficacious, this research could be highly impactful, causing us to rethink our approach to care for those with T2DM and shift the paradigm for millions of individuals in the United States. Furthermore, this approach will demonstrate the feasibility of helping people engage in metabolic treatment strategies in a way that is scalable leveraging digital and mobile solutions that extend the patient-provider relationship, shift care from episodic approaches to more of an on-going model that extends into the life of the patient, while also integrated within the healthcare system workflows.
This project will determine if a data-assisted, high intensity medical weight loss intervention (HIWL) will lead to significant weight loss and diabetes remission in individuals with a Body Mass Index (BMI) 30-39.9 kg/m2 with T2DM of less than 6 years as compared to a diabetes self-management education intervention (DSME). Complete diabetes remission is considered to be achieved when the patient is not taking any anti-diabetes medication for at least 12 months, and the Glycated Hemoglobin (HbA1c) is < 5.7%. Partial remission is achieved when the patient is not taking any anti-diabetes medication and has an HbA1c of 5.7-6.4% for at least 12 months.Using a randomized controlled study design, we will randomly assign 90 participants to HIWL, HIWL + continuous glucose monitoring (CGM), or DSME. Participants assigned to HIWL will receive a high intensity behavioral weight loss intervention delivered using a digital patient engagement platform. Participants will be prescribed a low calorie dietary plan and a recommended physical activity program designed to produce 15-20% weight loss over 12 months. Those assigned to HIWL + CGM will receive the same intervention as HIWL; in addition we will provide them with CGM to use as part of their remote monitoring on a daily basis. Those assigned to DSME will participate in a comprehensive diabetes education program designed to provide education and skills for optimal diabetes management plus lifestyle modification counseling to produce 5% weight loss over the same timeframe. The primary outcome of weight loss will be assessed at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity medical weight loss (HIWL) | Experimental | Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss. |
|
| Diabetes self-management education (DSME) | Active Comparator | The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings. The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process. |
|
| High intensity medical weight loss (HIWL) plus continuous glucose monitoring (CGM) | Experimental | Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical weight loss | Behavioral | Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in weight from baseline | baseline through 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Change in hemoglobin A1c | baseline through 12 months |
| Number of Subjects in Diabetes Remission | Number of participants achieving A1c <6.5% and no anti-diabetes medications |
| Measure | Description | Time Frame |
|---|---|---|
| International Physical Activity Questionnaire (IPAC) Short Form: Walking Minutes | A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of walking for exercise. Outcome is average total minutes/week. | baseline, 3 months, 6 months, and 12 months |
Inclusion:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamy Ard, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Univesity Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Individual participant data that underlie the results of any reported manuscripts after deidentification will be made available for the specified timeframes. Researchers who provide a methodologically sound proposal for analysis will be granted access.
Beginning 9 months and ending 36 months following any publication.
Proposals will need to be sent to jard@wakehealth.edu for review and approval. To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Intensity Medical Weight Loss (HIWL) | Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss. Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight |
| FG001 | Diabetes Self-management Education (DSME) | The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings. The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process. Diabetes education: Participants will receive standard of care diabetes education |
| FG002 | High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM) | Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways. Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Intensity Medical Weight Loss (HIWL) | Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss. Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight |
| 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 | Change in Body Weight | Change in weight from baseline | HIWL Arm: 8 missing weight measurement at month 12. DSME Arm: 15 missing weight measurement at month 12. HIWL/CGM Arm: 4 missing weight measurement at month 12. | Posted | Mean | Standard Deviation | kg | baseline through 12 months |
|
baseline through month 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Intensity Medical Weight Loss (HIWL) | Participants randomized to the HIWL treatment group will be placed on a meal replacement-based weight loss protocol. Participants will consume a minimum of 80 grams of protein daily in 4-5 servings of meal replacement. Participants will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-24, caloric prescriptions will be between 1100 to 1600 calories a day, using a combination of meal replacements and food, for continued weight loss. Beyond week 25, caloric intake will be individually tailored to achieve continued gradual weight loss or maintenance of body weight based on individual weight loss goals. We will recommend continued use of at least 1 serving of meal replacement per day for maintenance of weight loss. Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| surgery, no hospitalization | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Newman | Atrium Health Wake Forest Baptist | 336-713-1411 | chelsea.newman@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2022 | Dec 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 8, 2023 | Feb 26, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Randomized controlled trial
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|
| Diabetes education | Behavioral | Participants will receive standard of care diabetes education |
|
| Continuous glucose monitoring | Behavioral | Participants will use CGM devices to track blood glucose levels in near real time |
|
| 12 months |
| Continuous Glucose Monitoring (CGM) Time in Range | Average time spent at an average glucose of 100 mg/dL or lower collected by FreeStyle Libre. | baseline and month 12 |
| Continuous Glucose Monitoring Time in Range--Post-meal Glucose | Average time spent at a post-meal glucose level of 110 mg/dL or lower collected by FreeStyle Libre. | baseline through 12 months |
| Continuous Glucose Monitor Time in Range--Fasting Glucose | Average time spent in normal fasting glucose between 72-85 mg/dL collected by FreeStyle Libre. | baseline through 12 months |
| Continuous Glucose Monitor - Episodes of Hypoglycemia | Number of episodes hypoglycemia (<70 mg/dL) episodes collected by FreeStyle Libre. | baseline and month 12 |
| Continuous Glucose Monitor - Glucose Variability | Coefficient of variance collected by FreeStyle Libre. | baseline and month 12 |
| Continuous Glucose Monitoring - Average Glucose | Average glucose (mg/dL) collected by FreeStyle Libre. | baseline and 12 months |
| Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake | kilocalories averaged across 3 days | baseline, 3 months, 6 months, and 12 months |
| ASA24 Macronutrient Composition of Diet | %Carbohydrate/Fat/Protein; averaged across 3 days | baseline, 3 months, 6 months, and 12 months |
| ASA24 Number of Eating Episodes Per Day | averaged across 3 days | baseline, 3 months, 6 months, and 12 months |
| ASA24 Healthy Eating Index (HEI)-2015 Score | A validated summary measure of dietary quality, rated on a 100-point scale with a higher score denoting better diet quality | baseline, 3 months, 6 months, and 12 months |
| Daily Step Counts | Collected by pedometer over 7 days during each period. At the end of the 7th day, participants will record the final step count, and return the pedometer to the study team via a pre-stamped mail envelope. | baseline, 3 months, 6 months, and 12 months |
| Change in Quality of Life | The EuroQol's EQ-5D-5L will be used to measure quality of life. This instrument takes responses to five questions on mobility, self-care, ability to perform usual activities, pain, and anxiety/depression to produce a validated quality score. Total score range is 5-25 with a lower score indicating a better quality of life. | from baseline to month 12 |
| Change in Perceived Health Rating | The EuroQol's EQ-5D-5L visual analog scale will be used to measure participants perceived health. On a scale of 0-100 participants will rate their health. 0 means the worst health you can imagine. 100 means the best health you can imagine. | from baseline to month 12 |
| International Physical Activity Questionnaire (IPAC) Short Form: Sitting Time |
A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of sitting time. Outcome is average total minutes/week. |
| baseline, 3 months, 6 months, and 12 months |
| International Physical Activity Questionnaire (IPAC) Short Form: Moderate-vigorous Physical Activity Minutes | A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of moderate and vigorous physical activity. Outcome is average total minutes/week. | baseline, 3 months, 6 months, and 12 months |
| Death |
|
| BG001 | Diabetes Self-management Education (DSME) | The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings. The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process. Diabetes education: Participants will receive standard of care diabetes education |
| BG002 | High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM) | Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways. Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Diabetes Self-management Education (DSME) | The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings. The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process. Diabetes education: Participants will receive standard of care diabetes education |
| OG002 | High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM) | Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways. Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time |
|
|
| Secondary | Change in Hemoglobin A1c | Change in hemoglobin A1c | HIWL Arm: 8 missing month 12 labs. DSME Arm: 15 missing month 12 labs. HIWL/CGM: 1 missing baseline labs, 5 missing month 12 labs. | Posted | Mean | Standard Deviation | percentage of change in hemoglobin A1c | baseline through 12 months |
|
|
|
| Secondary | Number of Subjects in Diabetes Remission | Number of participants achieving A1c <6.5% and no anti-diabetes medications | HIWL Arm: 8 missing month 12 labs. DSM Arm: 15 missing month 12 labs. HIWL/CGM Arm: 5 missing month 12 labs. Participants who are missing month 12 labs were lost to follow up, withdrew consent, or unwilling to perform labs at final study visit. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Continuous Glucose Monitoring (CGM) Time in Range | Average time spent at an average glucose of 100 mg/dL or lower collected by FreeStyle Libre. | Sample size reflects participants with at least one valid CGM reading contributing to the specified outcome. For baseline, data was missing from 2 participants in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 7 (5 without sufficient data, 1 was lost to follow up, and 1 was deceased). DSME Arm: 6 (5 without sufficient data; 1 participant missing due to withdrawing). HIWL/CGM Arm: 6 without sufficient data | Posted | Mean | Standard Deviation | % of time | baseline and month 12 |
|
|
|
| Secondary | Continuous Glucose Monitoring Time in Range--Post-meal Glucose | Average time spent at a post-meal glucose level of 110 mg/dL or lower collected by FreeStyle Libre. | Sample size reflects participants with at least one valid CGM reading contributing to the specified outcome. For baseline, data was missing from 2 participants in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 7 (5 without sufficient data, 1 was lost to follow up, and 1 was deceased). DSME Arm: 6 (5 without sufficient data; 1 participant missing due to withdrawing). HIWL/CGM Arm: 6 without sufficient data | Posted | Mean | Standard Deviation | % of time | baseline through 12 months |
|
|
|
| Secondary | Continuous Glucose Monitor Time in Range--Fasting Glucose | Average time spent in normal fasting glucose between 72-85 mg/dL collected by FreeStyle Libre. | Sample size reflects participants with at least one valid CGM reading contributing to the specified outcome. For baseline, data was missing from 2 participants in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 7 (5 without sufficient data, 1 was lost to follow up, and 1 was deceased). DSME Arm: 10 (9 without sufficient data; 1 participant missing due to withdrawing). HIWL/CGM Arm: 6 without sufficient data | Posted | Mean | Standard Deviation | % of time | baseline through 12 months |
|
|
|
| Secondary | Continuous Glucose Monitor - Episodes of Hypoglycemia | Number of episodes hypoglycemia (<70 mg/dL) episodes collected by FreeStyle Libre. | Baseline data was missing from 1 participant in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 4 not analyzed (3 participants missing due to withdrawing, and 1 was deceased). DSME Arm: 3 not analyzed (3 participants missing due to withdrawing). HIWL/CGM Arm: 1 participant due to withdrawing | Posted | Mean | Standard Deviation | number of hypoglycemia episodes/person | baseline and month 12 |
|
|
|
| Secondary | Continuous Glucose Monitor - Glucose Variability | Coefficient of variance collected by FreeStyle Libre. | Baseline data was missing from 1 participant in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 4 not analyzed (3 participants missing due to withdrawing, and 1 was deceased). DSME Arm: 3 not analyzed (3 participants missing due to withdrawing). HIWL/CGM Arm: 1 participant due to withdrawing | Posted | Mean | Standard Deviation | percentage of coefficient of variation | baseline and month 12 |
|
|
|
| Secondary | Continuous Glucose Monitoring - Average Glucose | Average glucose (mg/dL) collected by FreeStyle Libre. | Baseline data was missing from 1 participant in the HIWL Arm, 2 participants in the DSME Arm, and 1 participant in the HIWL/CGM Arm. For M12 data: HIWL Arm: 4 not analyzed (3 participants missing due to withdrawing, and 1 was deceased). DSME Arm: 3 not analyzed (3 participants missing due to withdrawing). HIWL/CGM Arm: 1 participant due to withdrawing | Posted | Mean | Standard Deviation | mg/dL | baseline and 12 months |
|
|
|
| Secondary | Automated Self-Administered 24-hour (ASA24) Total Daily Energy Intake | kilocalories averaged across 3 days | Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible. | Posted | baseline, 3 months, 6 months, and 12 months |
|
|
| Secondary | ASA24 Macronutrient Composition of Diet | %Carbohydrate/Fat/Protein; averaged across 3 days | Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible. | Posted | baseline, 3 months, 6 months, and 12 months |
|
|
| Secondary | ASA24 Number of Eating Episodes Per Day | averaged across 3 days | Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible. | Posted | baseline, 3 months, 6 months, and 12 months |
|
|
| Secondary | ASA24 Healthy Eating Index (HEI)-2015 Score | A validated summary measure of dietary quality, rated on a 100-point scale with a higher score denoting better diet quality | Outcome data for this variable cannot be reported because the data are no longer available. The relevant outcome measures were collected using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24). After completion of the study, the specific version of ASA24 used for data collection was sunset and decommissioned. The data could not be transferred to the subsequent version of the ASA24 platform, and the original dataset is no longer accessible. | Posted | baseline, 3 months, 6 months, and 12 months |
|
|
| Secondary | Daily Step Counts | Collected by pedometer over 7 days during each period. At the end of the 7th day, participants will record the final step count, and return the pedometer to the study team via a pre-stamped mail envelope. | HIWL Arm: Missing 1 participant at baseline, 19 at month 3, 18 at month 6, 19 at month 12. DSME Arm: Missing 1 participant at baseline, 18 at month 3, 17 at month 6, 22 at month 12. HIWL/CGM Arm: Missing 12 participants at month 3, 10 at month 6, 17 at month 12. Participants were missing due to failure to return equipment, refusal to use pedometer or lost to follow up. | Posted | Mean | Standard Deviation | step count | baseline, 3 months, 6 months, and 12 months |
|
|
|
| Secondary | Change in Quality of Life | The EuroQol's EQ-5D-5L will be used to measure quality of life. This instrument takes responses to five questions on mobility, self-care, ability to perform usual activities, pain, and anxiety/depression to produce a validated quality score. Total score range is 5-25 with a lower score indicating a better quality of life. | 8 participants in HIWL arm, 15 participants in DSME arm and 4 participants in HIWL/CGM arm were lost to follow up, dropped from study or missing data at baseline visit. | Posted | Mean | Standard Deviation | score on a scale | from baseline to month 12 |
|
|
|
| Secondary | Change in Perceived Health Rating | The EuroQol's EQ-5D-5L visual analog scale will be used to measure participants perceived health. On a scale of 0-100 participants will rate their health. 0 means the worst health you can imagine. 100 means the best health you can imagine. | 8 participants in HIWL arm, 16 participants in DSME arm and 4 participants in HIWL/CGM arm were lost to follow up, dropped from study or missing data at baseline visit. | Posted | Mean | Standard Deviation | score on a scale | from baseline to month 12 |
|
|
|
| Other Pre-specified | International Physical Activity Questionnaire (IPAC) Short Form: Walking Minutes | A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of walking for exercise. Outcome is average total minutes/week. | This measure was not collected as it was considered redundant with the other assessment of physical activity and was not part of the IRB approved measures. | Posted | baseline, 3 months, 6 months, and 12 months |
|
|
| Other Pre-specified | International Physical Activity Questionnaire (IPAC) Short Form: Sitting Time | A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of sitting time. Outcome is average total minutes/week. | This measure was not collected as it was considered redundant with the other assessment of physical activity and was not part of the IRB approved measures. | Posted | baseline, 3 months, 6 months, and 12 months |
|
|
| Other Pre-specified | International Physical Activity Questionnaire (IPAC) Short Form: Moderate-vigorous Physical Activity Minutes | A validated self-report measure of daily physical activity levels. Responses are given as minutes per day over the last week of moderate and vigorous physical activity. Outcome is average total minutes/week. | This measure was not collected as it was considered redundant with the other assessment of physical activity and was not part of the IRB approved measures. | Posted | baseline, 3 months, 6 months, and 12 months |
|
|
| 1 |
| 22 |
| 1 |
| 22 |
| 8 |
| 22 |
| EG001 | Diabetes Self-management Education (DSME) | The DSME intervention will be administered and delivered at the Wake Forest Baptist Health Diabetes Center, located next to the Weight Management Center, by a team of certified diabetes educators, nurses, and nutritionists in group and individual settings. The diabetes education program is accredited by the American Diabetes Association in recognition of meeting national standards for diabetes self-management education. The goal of the program is to provide participants with information to make informed decisions about how to best integrate diabetes management strategies into their daily lives. Assessment, planning, implementation, and evaluation are the basic components of the diabetes education process. Diabetes education: Participants will receive standard of care diabetes education | 0 | 22 | 0 | 22 | 2 | 22 |
| EG002 | High Intensity Medical Weight Loss (HIWL) Plus Continuous Glucose Monitoring (CGM) | Participants randomized to the HIWL + CGM treatment group will be placed on a meal replacement-based weight loss protocol as described in the HIWL arm. In addition, the participants in this arm will receive a supply of continuous glucose monitors to use throughout the trial. The CGM we provide will give the patient instant feedback on blood glucose levels and be readable using a mobile phone device or an associated CGM reader. The data from the CGM will be integrated into the Carium app and used to help guide the patient's actions based on defined care pathways. Medical weight loss: Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight Continuous glucose monitoring: Participants will use CGM devices to track blood glucose levels in near real time | 0 | 20 | 0 | 20 | 5 | 20 |
| broken bone | Injury, poisoning and procedural complications | Systematic Assessment |
|
| shortness of breath | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| dizziness/balance problem | General disorders | Systematic Assessment |
|
| leg weakness | General disorders | Systematic Assessment |
|
| nausea | General disorders | Systematic Assessment |
|
| muscle or joint pain | General disorders | Systematic Assessment |
|
| Covid-19 | Infections and infestations | Systematic Assessment |
|
| abscess | General disorders | Systematic Assessment |
|
| constipation | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
| month 12 |
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| 12 months |
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| 12 months |
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| month 12 |
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| month 12 |
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| month 12 |
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| month 3 |
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| month 6 |
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| month 12 |
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