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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK119379 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Institutes of Health (NIH) | NIH |
| Rowan University | OTHER |
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The purpose of this study is to conduct a randomized controlled trial (RCT) to determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose control in adults with uncontrolled type 1 or type 2 diabetes. The study will randomize at least 290 adults with uncontrolled diabetes to a 6-month MBSR intervention or SME control. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. Outcomes will be assessed at baseline, a follow-up phone call after Class #4, and study visits at 2-months (2MO) and 6-months (6MO).
Specific Aims are: 1) To conduct a randomized controlled trial to determine the effects of an online 6-month Mindfulness-Based Stress Reduction (MBSR) intervention compared to an active control Stress Management Education (SME) on glucose levels in at least 290 adults with uncontrolled type 1 or type 2 diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing. The primary outcome will be hemoglobin A1c (HbA1c), a measure of the average glucose level over the past 3 months. We hypothesize that between the two groups, there will be a clinically significant 0.5% absolute difference in the mean change in HbA1c from baseline to 6-months. We will also look at the 2-month HbA1c, however it may be too brief a time period to fully capture the impact of MBSR. An absolute reduction in HbA1c of 0.5% would be expected to reduce the risk of any diabetes-related complication by at least 10%. Additionally, we will assess fasting glucose as a secondary outcome as it is linked with adverse health outcomes, and can be lowered with MBSR based on our pilot study; 2) To determine the effects of online MBSR compared to SME control on psychosocial, behavioral and physiological mechanisms potentially mediating the effects of MBSR and/or SME on glucose levels in adults with uncontrolled diabetes. Secondary outcomes include: diabetes-related distress, subjective stress, craving, the impact of Coronavirus Disease 2019 (COVID-19) on subjects' lives, subject expectancy, dietary intake, physical activity, and serum hsCRP as a marker of chronic inflammation. Adverse Childhood Experiences (ACEs) will be assessed at baseline. It is hypothesized that these measures may mediate the effects of MBSR and/or SME on glucose.
The proposed study has the potential to transform current standards of care for diabetes by using a novel long-term MBSR intervention as a powerful adjunct intervention for diabetes. MBSR could impact the clinical picture of diabetes by empowering patients with skills for strengthening their own internal resources to promote self regulation and adaptive coping and reduce stress reactivity, which are all essential for implementing healthy behaviors and are expected to lead to improved glucose control and reduced risk of diabetes complications. This proposal is relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct research on diabetes to improve people's health and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Experimental |
| |
| Stress Management Education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction | Behavioral | Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self-Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). | Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 6MO data are reported here as the primary comparison. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nazia T Raja-Khan, M.D., M.S. | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine, Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
De-identified individual participant data will be available upon request approval beginning one year following the trial's initial publication date. All data requests must be submitted to the Principal Investigator (PI) in the form of a brief proposal outlining the research questions and aims, statistical analysis plan, specific measures needed, funding availability or sponsors involved (if applicable), and any other details pertaining to the proposed project. Proposals will be reviewed by the PI and relevant study team members within 3 months upon receipt.
Proposals will be reviewed and considered for approval beginning one year following the trial's initial publication date
For data request proposals that receive approval, consultations will be scheduled to coordinate any relevant or applicable Institutional Review Board (IRB) considerations and/or data use agreements pertaining to the specific data requested.
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497 consents were signed following pre-screening at the start of the initial screening visit, reflecting n=492 unique consented individuals. Study eligibility criteria were assessed further during the screening visit and baseline visit. 183 individuals were consented but never randomized (never enrolled; n=161 ineligible at screening visit, n=1 ineligible at baseline visit, n=14 withdrew from the study, n=1 died, n=6 study team withdraws). 309 (492-183) individuals were enrolled and randomized.
Recruitment from medical clinics, support groups, health fairs, StudyFinder, ResearchMatch, HealthGrades, and social media began 2/26/20 with final participant screened 1/17/24. First consent to study was 7/28/20. Type 2 diabetics were eligible for the study until 7/22/21, then expanding to all diabetics (except gestational diabetes). Eligibility was HbA1c ≥ 8 until 5/9/22, when eligible HbA1c dropped to ≥ 7.5. Final follow-up for primary outcome data collection was on 8/9/24.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Based Stress Reduction | MBSR course (Intervention) - 8-week University of Massachusetts Mindfulness-Based Stress Reduction curriculum adapted for live online delivery due to the Coronavirus Disease 2019 (COVID-19) pandemic; 1 orientation, 6 weekly classes, 1 retreat (long class session), 2 weekly classes, 4 monthly booster sessions; participants are asked to do at least 25-30 minutes of home practice homework per day for 6 days each week for the first 7 weeks following the first class. Home practice homework included mindfulness activities in accordance with the standard MBSR curriculum. Following the last weekly class, participants are encouraged to continue their home practice activities regularly on their own. Examples of MBSR activity engagement includes mindful walking, mindful yoga, mindful eating, and body scans. MBSR does not cover health education. Both arms received the following general information at their baseline visit: Two handouts from the American Diabetes Association Patient Education Library, 1) "Plan Your Portions" Diabetes Placemat and 2) "The Diabetes Advisor - Physical Activity", and three additional handouts covering 3) Hyperglycemia/Hypoglycemia, 4) Glucometer Best Practices, and 5) Blood Glucose Meter Correlation. |
| FG001 | Stress Management Education | SME course (Active Control) - Dr. Elizabeth Hoge's Stress Management Education program curriculum adapted for live online delivery due to the COVID-19 pandemic; 1 orientation, 6 weekly classes, 1 retreat (long class session), 2 weekly classes, 4 monthly booster sessions; participants are asked to do at least 25-30 minutes of home practice homework per day for 6 days each week for the first 7 weeks after the first class. Home practice homework included listening to excerpts of audiobooks about general stress management or nutrition facts. Following the last weekly class, participants are encouraged to continue their home practice activities regularly on their own. The SME curriculum was specifically created as a control condition for MBSR studies to parallel the intervention's structure with respect to time, schedule, social support, homework, etc. SME does not cover mindfulness. The SME program includes nutrition (adapted for individuals with diabetes), exercise as gentle stretching with Theraband to parallel the yoga component of MBSR, and other general health topics, such as sleep. Both arms received the following general information at their baseline visit: Two handouts from the American Diabetes Association Patient Education Library, 1) "Plan Your Portions" Diabetes Placemat and 2) "The Diabetes Advisor - Physical Activity", and three additional handouts covering 3) Hyperglycemia/Hypoglycemia, 4) Glucometer Best Practices, and 5) Blood Glucose Meter Correlation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All randomized participants; participants age 18 or older were eligible to participate.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Based Stress Reduction | Mindfulness Based Stress Reduction: Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations. |
| Units | Counts |
|---|---|
| Participants |
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| 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 A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 6-Months (6MO) | Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self-Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). | Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=306 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=151; SME=155) and n=237 contributing values to the 6MO timepoint Least Squares Mean (MBSR=114; SME=123). | Posted | Least Squares Mean | 95% Confidence Interval | percentage of glycated hemoglobin | Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 6MO data are reported here as the primary comparison. |
Adverse event data were collected from consent through end of trial for each individual (up to roughly 6 months after orientation). Adverse events were followed until resolution/stabilization or until end of trial.
All Serious Adverse Events (SAEs) are reported here for all consenting individuals. Adverse Events (AEs) were regularly solicited at baseline, 4-wk call, 2MO, and 6MO visits via systematic open-ended check-ins ("Have there been any changes to your health since the last visit?") and questionnaires (e.g. Hypoglycemia Survey) through self-report. Self-initiated reporting of AEs between visits was encouraged. Efforts were made to obtain supporting documentation from medical records as needed.
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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 | Mindfulness Based Stress Reduction | Mindfulness Based Stress Reduction: Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
The study could not be conducted without participant awareness of their randomly assigned course. Course cohorts were variable in size. SME course cohorts were taught by several different instructors throughout the duration of the trial. The COVID-19 pandemic may have impacted participant stress. HbA1c was measured using home kits. Study visits were conducted remotely, and surveys were completed electronically, therefore biasing the study sample towards more technologically capable participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nazia T Raja-Khan, M.D., M.S., Associate Prof, Dept of Medicine, Div. of Endocrin & Diabetes | Milton S. Hershey Medical Center, Penn State Hershey College of Medicine | 717-531-8395 | nrajakhan@pennstatehealth.psu.edu |
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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 | Dec 13, 2024 | Aug 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 1, 2024 | Aug 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003922 | Diabetes Mellitus, Type 1 |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| West Chester University of Pennsylvania |
| OTHER |
| Georgetown University | OTHER |
This is a randomized, parallel group two-arm trial that will determine the effects of an online 6-month Mindfulness-based stress reduction (MBSR) intervention compared to Stress Management Education (SME) (active control) on glucose control in at least 290 patients with uncontrolled diabetes. Both MBSR and SME will be delivered online by experienced instructors in a live interactive virtual classroom using videoconferencing.
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The PI, study coordinator, and all study personnel collecting outcomes, will be blinded from the treatment assignments. Only the MBSR and SME instructors and the study personnel who schedule the classes, videorecord the classes, and code the videos will have knowledge of the assignments, and these individuals will not be involved in the collection of outcomes. Subjects will be asked to keep their treatment assignment concealed from study personnel collecting outcomes. However, complete blinding may not be possible given the nature of this study.
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| Stress Management Education | Behavioral | Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc. |
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| Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 2MO data are reported here as the secondary comparison |
| Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 ("not a problem") to 6 ("a very serious problem"), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). | The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 2MO data are reported here as the comparison for this outcome. |
| Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 ("not a problem") to 6 ("a very serious problem"), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). | The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 6MO data are reported here as the comparison for this outcome. |
| Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). | PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 2MO data are presented here as the comparison for this outcome. |
| Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). | PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 6MO data are presented here as the comparison for this outcome. |
| Physician Decision |
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| Pregnancy |
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| Withdrawal by Subject |
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| Participant Non-Compliance: Orientation not completed prior to Class #2 |
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| BG001 | Stress Management Education | Stress Management Education: Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
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| Type of Diabetes | Type of diabetes diagnosed for at least one year prior to trial eligibility assessment; only participants with Type 2 Diabetes were eligible to participate in the trial until 07/22/2021 (cohorts 1-4), after which time recruitment was expanded to include any type of diabetes, except gestational diabetes during pregnancy (cohorts 5-14). Therefore, this measure reflects values self-reported by participants collected during the screening visit, from the participant's electronic medical record (EMR), and/or baseline visit. | Count of Participants | Participants | No |
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| Randomization Stratification Factor; Taking Insulin at Baseline | Does the participant report currently taking any form of insulin at the time of the baseline visit prior to randomization?; self-reported by participants and verified on participant medications list by research coordinator. | Count of Participants | Participants | No |
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| A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values | Home Hemoglobin A1c (HbA1c) was measured using the PTS Diagnostics A1CNow® Self-Check Kit during screening and/or baseline visit (pre-randomization values). 89 values were carried forward to baseline from screening that took place within 14 days prior to baseline, and 217 values were collected at baseline. Of the n=154 participants randomized to MBSR arm, n=3 participants were missing pre-randomization values (n=2 protocol deviations - values not recollected at baseline with screening values collected > 14 days prior; n=1 protocol deviation - no pre-randomization home kit value collected). | Of the n=154 participants randomized to MBSR arm, n=3 participants were missing pre-randomization values (n=2 protocol deviations - values not recollected at baseline with screening values collected > 14 days prior; n=1 protocol deviation - no pre-randomization home kit value collected). | Mean | Standard Deviation | percentage of glycated hemoglobin |
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| Class Cohort Number | The trial enrolled 14 class cohorts. Orientation date reflects the start of the class cohort. | Count of Participants | Participants | No |
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| Diabetes Distress Scale (DDS) Mean Item Score | The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 ("not a problem") to 6 ("a very serious problem"), with higher scores indicating more diabetes-related distress, with a recall timeframe for the past month. The DDS Mean Item score is calculated as the average of all 17 items on the scale. | Mean | Standard Deviation | scores on a scale |
|
| Perceived Stress Scale-10 (PSS-10) Score | The Perceived Stress Scale-10 (PSS-10) is a 10-item survey measuring subjective stress on a scale from 0 ("never") to 4 ("very often"), with a recall timeframe for the last month, collected at screening and baseline visits. The scale includes both positive and negative worded items. After reversing four positive items, the score is calculated as the sum of all 10 items (0 to 40), with higher scores indicating higher levels of perceived stress. Pts screening for cohorts 1 and 2 (until 9/3/20) were eligible if their score upon screening was at least 20; then onward, a score of at least 12. | Mean | Standard Deviation | scores on a scale |
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| Secondary | Change in A1CNow® Self-Check Hemoglobin A1c (HbA1c) Home Kit Values From Baseline to 2-Months (2MO) | Home Hemoglobin A1c (HbA1c) was measured and collected using the PTS Diagnostics A1CNow® Self Check Kit. See Baseline Characteristics section for more details on this outcome measure. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). | Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=306 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=151; SME=155) and n=244 contributing values to the 2MO timepoint Least Squares Mean (MBSR=122; SME=122). | Posted | Least Squares Mean | 95% Confidence Interval | percentage of glycated hemoglobin | Home HbA1c was collected during the screening and/or baseline visit (pre-randomization values; see Baseline Characteristics section), 2MO visit, and 6MO visit (post-randomization values). Baseline and 2MO data are reported here as the secondary comparison |
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| Secondary | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 2-Months (2MO) | The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 ("not a problem") to 6 ("a very serious problem"), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). | Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=247 contributing values to the 2MO timepoint Least Squares Mean (MBSR=123; SME=124). | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 2MO data are reported here as the comparison for this outcome. |
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| Secondary | Change in Diabetes Distress Scale (DDS) Mean Item Score From Baseline to 6-Months (6MO) | The Diabetes Distress Scale (DDS) is a 17-item survey asked on a scale from 1 ("not a problem") to 6 ("a very serious problem"), with higher scores indicating more diabetes-related distress. The DDS Mean Item score is calculated as the average of all 17 items on the scale. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). | Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=236 contributing values to the 6MO timepoint Least Squares Mean (MBSR=115; SME=121). | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | The DDS was collected during each participant's baseline, 2MO, and 6MO visit and is framed with a recall time frame of the past month. Baseline and 6MO data are reported here as the comparison for this outcome. |
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| Secondary | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 2-Months (2MO) | PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 2MO from this model (where all three study visit timepoints are included in the time effect). | Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=246 contributing values to the 2MO timepoint Least Squares Mean (MBSR=123; SME=123). | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 2MO data are presented here as the comparison for this outcome. |
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| Secondary | Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline to 6-Months (6MO) | PSS-10 is a 10-item survey that includes both positive and negative phrased items on a scale of 0-4. After reversing 4 positive items, the summative score ranges from 0-40, where higher values indicate higher levels of perceived stress, with a recall time frame for the last month. The Least Squares Means reported are model-based estimates of constructed contrasts from the linear mixed effects model further specified in the Stat Analysis results section that included fixed effects for arm, time (visit; baseline, 2MO, 6MO), the randomization stratification factor of insulin status at baseline, and the interaction between arm and time, with random effects accounting for subjects and class cohort number nested within arm, and a residual effect to account for longitudinally repeated measures over time. This outcome measure reports the difference between group arms in the change from Baseline to 6MO from this model (where all three study visit timepoints are included in the time effect). | Following intention-to-treat (ITT) principles, all N=309 randomized participants were included in the analysis model. Therefore, the overall number of participants analyzed for this outcome remains N=309, with n=309 participants contributing values to the baseline timepoint Least Squares Mean (MBSR=154; SME=155) and n=238 contributing values to the 6MO timepoint Least Squares Mean (MBSR=115; SME=123). | Posted | Least Squares Mean | 95% Confidence Interval | scores on a scale | PSS-10 was assessed at screening, baseline (pre-randomization), 2MO, and 6MO visits. Baseline and 6MO data are presented here as the comparison for this outcome. |
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|
|
| 0 |
| 154 |
| 15 |
| 154 |
| 43 |
| 154 |
| EG001 | Stress Management Education | Stress Management Education: Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc. | 0 | 155 | 18 | 155 | 46 | 155 |
| EG002 | Consented - Not Randomized | Individuals who consented to the trial but were not randomized to a study group arm. | 1 | 183 | 1 | 183 | 0 | 183 |
| Hematoma | Blood and lymphatic system disorders | CTCAE v5.0 | Systematic Assessment |
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| Conduction Disorder | Cardiac disorders | CTCAE v5.0 | Systematic Assessment |
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| Gastroparesis | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
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| Bone Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Lung Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Skin Infection | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | CTCAE v5.0 | Systematic Assessment |
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| Wound Dehiscence | Injury, poisoning and procedural complications | CTCAE v5.0 | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE v5.0 | Systematic Assessment |
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| Rotator Cuff Injury | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
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| Cutaneous T-cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v5.0 | Systematic Assessment |
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| Stroke | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Suicidal Ideations | Psychiatric disorders | CTCAE v5.0 | Systematic Assessment |
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| Renal Calculi | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
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| Thromboembolic event subacute thrombosis right leg bypass graft | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | CTCAE v5.0 | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004191 |
| Behavioral Disciplines and Activities |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Latent Autoimmune Diabetes in Adults (LADA) |
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| Diabetes due to pancreatitis or pancreatectomy (surgical removal of all or part of the pancreas) |
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| Drug- or chemical-induced diabetes (such as with steroid use or after organ transplantation) |
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| Cohort 3: Orientation Date = 05/06/2021 |
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| Cohort 4: Orientation Date = 07/20/2021 |
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| Cohort 5: Orientation Date = 09/28/2021 |
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| Cohort 6: Orientation Date = 01/25/2022 |
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| Cohort 7: Orientation Date = 04/19/2022 |
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| Cohort 8: Orientation Date = 07/26/2022 |
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| Cohort 9: Orientation Date = 10/04/2022 |
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| Cohort 10: Orientation Date = 01/24/2023 |
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| Cohort 11: Orientation Date = 04/18/2023 |
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| Cohort 12: Orientation Date = 07/11/2023 |
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| Cohort 13: Orientation Date = 09/26/2023 |
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| Cohort 14: Orientation Date = 01/23/2024 |
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| 2MO |
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| Change from Baseline to 2MO |
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All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms. |
| 2MO |
|
|
| Change from Baseline to 2MO |
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|
All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms. |
| 6MO |
|
|
| Change from Baseline to 6MO |
|
|
All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms. |
| 2MO |
|
|
| Change from Baseline to 2MO |
|
|
All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms. |
| 6MO |
|
|
| Change from Baseline to 6MO |
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|
All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms. |