Mindful Stress Reduction in Diabetes Self-management Education for Veterans

A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores are summed and multiplied by 1.25. Minimum value = 0; Maximum value = 100. Higher scores denote higher levels of diabetes related distress. The cutoff for significant distress is 33; a score of 40 is consistent with diabetes burn-out.

Time frame: baseline, 12 weeks and 24 weeks

Population: Numbers analyzed differ among rows from the overall number analyzed because of attrition and missed visits.

Change in mean arterial blood pressure, calculated as blood pressure + 2 (diastolic blood pressure) divided by 3.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed visit or shortened visit. Two participants did not have their BP taken at week 24 due to social distancing and COVID-19 precautions.~Analyzed as intention to treat with imputation moving last value forward.

Weight in pounds

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition or missed visit.~Analyzed as intention to treat with imputation moving last value forward.

An 8-item psychometrically validated self-report questionnaire on a 10- point Likert Scale (1= Not confident at all; 10 = Totally confident). This scale measures diabetes self efficacy, a critical pathway to improved self-management that refers to an individual's confidence in their ability to perform key diabetes self-management behaviors. Scores are derived as the mean of the 8 questions. Minimum score =1; Maximum Score = 10. Higher scores denote higher diabetes self-efficacy.

Time frame: baseline, 12 weeks and 24 weeks

Population: Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.

A blood test that measures the percentage of glycated hemoglobin in red blood cells as a means of estimating the average blood sugar concentrations for the preceding two to three months. Lower percentage denote better blood glucose levels and may range from 4.5% in persons without diabetes t0 \>15% in persons with poorly managed hyperglycemia. . An A1C \<7% has been associated with prevention of diabetes complications. A1C\>9% denotes chronic,severe blood glucose elevation. All tests were performed at VAPHS according to National Glyco-hemoglobin Standardization Program-approved methods.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed research assessment, missed visit or failure to go to the lab to have bloodwork done following the research assessment. Three participant in the intervention group and 2 participants in the DSME-alone group did not have A1C done following the 24 week assessment related to closure of the outpatient lab due to COVID-19.~Analyzed as intention to treat with imputation moving last value forward.

A 15-item psychometrically validated questionnaire on a 6-point Likert scale (1=Almost Always and 6= Never) The scale is scored by computing the mean of the 15 items. (Minimum score = 1; maximum score = 6). Higher scores reflect higher levels of dispositional (trait) mindfulness. Average score in the general US population is 4.22. Mindfulness is a mental state achieved by focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition and missed or abbreviated visit. One participant had to leave the 24 week visit after completing just 3 of the questionnaires and before completing the other questionnaires. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since 3 assessments including the primary outcome assessment were completed.~Analyzed as intention to treat with imputation moving last value forward.

The Patient Health Questionnaire (PHQ-8) is a standardized, validated scale that assesses 8 key symptoms of depression experienced over the prior two weeks on a 4-point Likert scale (0=not at all; 3= nearly every day). It is the same as the PHQ-9, without the question regarding suicidal ideation. Score is the sum of the 8 items (Minimum value =0; Maximum= 24). A score of 10 or greater is considered major depression, 20 or more is severe major depression.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed visit or missed assessments.One participant had to leave the 24 week visit after completing just 3 of the questionnaires. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since 3 assessments including the primary outcome assessment (PAID) were completed.~Analyzed as intention to treat with imputation moving last value forward.

The Abbreviated PCL-C is a validated 6-item civilian version of the PTSD check- list designed for use in general medical settings to assess symptoms of PTSD using a 5-point Likert scale. Scores reflect how much the participant has been bothered by specific PTSD symptoms during the past month. (0= not at all; 4= extremely) .Scores are summed. (Minimum value =0; maximum values = 24). Scores \>14 are suggestive of PTSD, with higher scores reflecting greater PTSD symptoms.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed or incomplete assessments. One participant left the 24- week visit early after completing just 3 of the questionnaires. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since 3 assessments including that for the primary outcome assessment were completed.~Analyzed as intention to treat with imputation moving last value forward.

A 2-item subscale of the SDSCA that measures 1) the number of days on which the participant tested their blood glucose over the past 7 days and 2) the number of days on which they tested their blood glucose according to the number of times recommended by their health care provider over the past 7-days. Scores= mean number of days per week. Minimum score is 0 Maximum score is 7.Higher scores denote healthier self-monitoring behaviors. Each SDSCA subscale scored separately

Time frame: baseline, 12 weeks, 24 weeks

Population: Differing sample sizes are due to attrition and missed research visits or skipped questionnaires. One person in each group did not complete the questionnaire at baseline because they were not prescribed blood glucose monitoring by their diabetes care providers.

A 2-item subscale of the SDSCA that measures the number of days over the past 7-days on which the participant engaged in physical activity . Score = mean score of days over the past 7 days (Min.=1; Max.=7). Higher scores denote healthier exercise behaviors. Each SDSCA subscale scored separately.

Time frame: baseline, 12 weeks, 24 weeks

Population: Differing sample sizes are due to attrition and missed research visits.

A 2-item subscale of the SDSCA that measures the number of days the participant 1) inspected their feet and 2) inspected the inside of their shoes over the past 7-days. Score = mean number of days (Min=0; max=7). Higher scores denote healthier footcare behaviors.

Time frame: baseline, 12 weeks, 24 weeks

Population: Differing sample sizes are due to attrition and missed research visits.

A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of general dietary behaviors each day over the past 7-days and number of days per week over the past month (0= no days; 7 = 7 days). Scores = mean number of days per week ( Minimum score =0; maximum score = 7) . Higher scores denote healthier dietary behaviors.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition or missed visit.

A 2-item subscale of the SDCSA that measures the frequency of 1) taking prescribed insulin and 2)prescribed number of diabetes pills each day over the past 7-days. Scores from the 2 items are summed. Minimum score =0; maximum score = 7). Higher scores denote greater adherence to diabetes medications. Participants entered N/A if they were not prescribed insulin or diabetes pills. Each subscale of the SDSCA is scored independently with no calculated composite score.

Time frame: baseline, 12 weeks, 24 weeks

Population: Differing sample sizes are due to attrition, missed research visits or missing assessment questions. One person in Usual Care Control Group did not take any diabetes medications as reflected in the overall number of participants analyzed in that group.

A 2-item subscale of the SDSCA that measures 1) whether the participant smoked even a puff of a cigarette in the past 7 days (0=no; 1= yes) and 2) if so, the number of cigarettes smoked on an average day. The scores are summed. Minimum score =0, maximum score = \>40. Lower scores denote healthier smoking behaviors.

Time frame: baseline,12 weeks, 24 weeks

Population: Differing sample sizes are due to attrition and missed research visits or incomplete assessment. Two participants in the DSME + Mind-STRIDE intervention group did not complete the Smoking subset of the SDSCA because they do not smoke.

One item from the SDSCA that assesses the number of days over the past 7-days in which the participant spaced carbohydrates evenly throughout the day. Minimum score 0; maximum score 7. Higher scores denote healthier dietary behaviors.

Time frame: baseline, 12 weeks and 24 weeks

Population: Differing sample sizes are due to attrition and missed research visits.

A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of eating fruits and vegetables and high fat foods each day over the past 7-days. Minimum maximum values = (0= no days; 7 = 7 days). 1 item is scored as mean number of days (Minimum score =0; maximum score = 7), while the 2nd item is summed and reversed (0= 7days; 7= 0 days). The scores for the two items are summed for the subscale score (Minimum score=0; maximum score =7) Higher scores denote healthier dietary behaviors. Each subscale of the SDSCA is scored separately, without a calculated composite score.

Time frame: baseline, 12 weeks and 24 weeks

Population: Differing sample sizes are due to attrition and missed research visits.

A psychometrically validated 7-item instrument on a 5 point Likert scale (1= not at all- 5 and very much) determining the degree to which pain has interfered with aspects of daily living during the past 7 days. It is a general and not disease-specific measure of pain. Scores are summed (Min. value = 6; Max value =35). Total raw scores are then converted into a T-score for each participant. The T-scores rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population with a standard deviation of 10.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition, missed visits, or skipped assessments. One participant had to leave the 24 week before completing the Pain Interference assessment. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis because he completed 3 of the other assessments including the primary outcome assessment..~Analyzed as intention to treat with imputation moving last value forward.

Seven psychometrically tested items on a 4 point Likert scale that measure difficulty falling asleep and staying asleep (0= none; 4=very severe) and satisfaction with current sleep patterns (0=very satisfied; 4=very dissatisfied), Noticeable impairment of quality of life (0= not noticeable; 4= very much noticeable), Worry/distress re: sleep (0=not at all worried; 4=very much worried); Interference of sleep problem to daily functioning (0=not interfering; 4= very much interfering). Scores are summed. Minimum score = 0; maximum score = 20). Higher scores denote greater insomnia severity. Scores over 14 denote insomnia; Scores 8 to 14 denote subthreshold insomnia.

Time frame: baseline, 12 weeks and 24 weeks

Population: Number analyzed differs in one or more rows from overall number analyzed due to attrition,missed visits or skipped assessments. One participant had to leave the 24 week visit before completing the ISI. He was then lost to follow-up. He was retained in the Intention-to-Treat analysis since he completed 3 of the other assessments including the primary outcome assessment.~Analyzed as intention to treat with imputation moving last value forward.