Trial Outcomes & Findings for Mindful Stress Reduction in Diabetes Self-management Education for Veterans (NCT NCT02928952)

NCT ID: NCT02928952

Last Updated: 2021-05-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 132 participants
• Primary outcome timeframe: baseline, 12 weeks and 24 weeks
• Results posted on: 2021-05-28

Participant Flow

Dates of recruitment: 11-1-2016 to 10-31-2019 Diabetes outpatient clinic at VA Pittsburgh Healthcare System, Oakland campus

One participant was excluded because of concomitant enrollment in a similar study that could have confounded results.

Participant milestones

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone Usual care control
Overall Study STARTED	65	67
Overall Study COMPLETED	55	60
Overall Study NOT COMPLETED	10	7

Reasons for withdrawal

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone Usual care control
Overall Study Lost to Follow-up	5	5
Overall Study Withdrawal by Subject	5	1
Overall Study Physician Decision	0	1

Baseline Characteristics

Mindful Stress Reduction in Diabetes Self-management Education for Veterans

Baseline characteristics by cohort

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control	Total n=132 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 10.5 • n=93 Participants	60.7 years STANDARD_DEVIATION 10.8 • n=4 Participants	60.7 years STANDARD_DEVIATION 10.6 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Sex: Female, Male Male	60 Participants n=93 Participants	61 Participants n=4 Participants	121 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	20 Participants n=93 Participants	23 Participants n=4 Participants	43 Participants n=27 Participants
Race (NIH/OMB) White	45 Participants n=93 Participants	44 Participants n=4 Participants	89 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	65 Participants n=93 Participants	67 Participants n=4 Participants	132 Participants n=27 Participants
Living with partner	26 Participants n=93 Participants	31 Participants n=4 Participants	57 Participants n=27 Participants
Post-High School Education	54 Participants n=93 Participants	52 Participants n=4 Participants	106 Participants n=27 Participants
Employment Status- working full or part time	18 Participants n=93 Participants	14 Participants n=4 Participants	32 Participants n=27 Participants
Diabetes Phenotype-type 2 diabetes	62 Participants n=93 Participants	62 Participants n=4 Participants	124 Participants n=27 Participants
Charlson Co-Morbidity Index (CMI)	4.31 units on a scale STANDARD_DEVIATION 141 • n=93 Participants	4.33 units on a scale STANDARD_DEVIATION 1.79 • n=4 Participants	4.32 units on a scale STANDARD_DEVIATION 1.61 • n=27 Participants
Insulin use	46 Participants n=93 Participants	47 Participants n=4 Participants	93 Participants n=27 Participants
Duration of Diabetes	12.09 years STANDARD_DEVIATION 9.67 • n=93 Participants	13.81 years STANDARD_DEVIATION 11.05 • n=4 Participants	12.96 years STANDARD_DEVIATION 10.39 • n=27 Participants

PRIMARY outcome

Timeframe: baseline, 12 weeks and 24 weeks

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

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) Baseline	27.58 units on a scale Standard Deviation 15.41	31.24 units on a scale Standard Deviation 16.72
Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) 12 weeks	17.00 units on a scale Standard Deviation 13.10	20.83 units on a scale Standard Deviation 13.32
Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) 24 weeks	12.89 units on a scale Standard Deviation 11.30	21.15 units on a scale Standard Deviation 13.02

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Diabetes Self-efficacy Scale (DSES) Baseline	6.20 score on a scale Standard Deviation 1.94	5.77 score on a scale Standard Deviation 1.95
Diabetes Self-efficacy Scale (DSES) 12 weeks	6.97 score on a scale Standard Deviation 1.91	6.40 score on a scale Standard Deviation 1.80
Diabetes Self-efficacy Scale (DSES) 24 weeks	7.26 score on a scale Standard Deviation 2.10	6.47 score on a scale Standard Deviation 1.92

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Hemoglobin A1c (A1C) Baseline	8.57 percentage of glycated Hemoglobin Standard Deviation 1.49	8.68 percentage of glycated Hemoglobin Standard Deviation 1.63
Hemoglobin A1c (A1C) 12 weeks	7.87 percentage of glycated Hemoglobin Standard Deviation 1.23	7.94 percentage of glycated Hemoglobin Standard Deviation 1.22
Hemoglobin A1c (A1C) 24 weeks	7.84 percentage of glycated Hemoglobin Standard Deviation 1.38	8.09 percentage of glycated Hemoglobin Standard Deviation 1.51

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Mindfulness Attention and Awareness Scale (MAAS) Baseline	4.37 score on a scale Standard Deviation 0.93	4.25 score on a scale Standard Deviation 0.85
Mindfulness Attention and Awareness Scale (MAAS) 12 weeks	4.49 score on a scale Standard Deviation 0.96	4.42 score on a scale Standard Deviation 0.85
Mindfulness Attention and Awareness Scale (MAAS) 24 weeks	4.52 score on a scale Standard Deviation 1.04	4.47 score on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: 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.

Weight in pounds

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Body Weight Baseline	227.80 Pounds Standard Deviation 40.14	233.64 Pounds Standard Deviation 50.15
Body Weight 12 weeks	229.16 Pounds Standard Deviation 38.97	231.24 Pounds Standard Deviation 48.29
Body Weight 24 weeks	229.63 Pounds Standard Deviation 38.92	231.04 Pounds Standard Deviation 49.53

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Blood Pressure 24 weeks	99.61 mmHg Standard Deviation 13.90	96.85 mmHg Standard Deviation 13.51
Blood Pressure Baseline	99.46 mmHg Standard Deviation 12.04	100.26 mmHg Standard Deviation 13.59
Blood Pressure 12 weeks	98.51 mmHg Standard Deviation 13.02	95.77 mmHg Standard Deviation 13.82

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Patient Health Questionnaire (PHQ8) 24 weeks	5.61 score on a scale Standard Deviation 5.46	7.20 score on a scale Standard Deviation 4.79
Patient Health Questionnaire (PHQ8) Baseline	8.22 score on a scale Standard Deviation 5.66	9.07 score on a scale Standard Deviation 5.78
Patient Health Questionnaire (PHQ8) 12 weeks	5.98 score on a scale Standard Deviation 5.05	6.97 score on a scale Standard Deviation 4.96

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
PTSD Checklist- Civilian Version (PCL-C) Baseline	13.22 score on a scale Standard Deviation 5.71	13.90 score on a scale Standard Deviation 5.69
PTSD Checklist- Civilian Version (PCL-C) 12 weeks	11.63 score on a scale Standard Deviation 4.87	12.49 score on a scale Standard Deviation 5.15
PTSD Checklist- Civilian Version (PCL-C) 24 weeks	11.09 score on a scale Standard Deviation 5.71	12.62 score on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA), General Diet Baseline	3.25 score on a scale Standard Deviation 2.07	3.51 score on a scale Standard Deviation 1.90
Summary of Diabetes Self-Care Activities (SDSCA), General Diet 12 week	4.60 score on a scale Standard Deviation 1.83	4.20 score on a scale Standard Deviation 1.51
Summary of Diabetes Self-Care Activities (SDSCA), General Diet 24 weeks	4.93 score on a scale Standard Deviation 1.51	3.88 score on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=66 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet 12 weeks	3.71 score on a scale Standard Deviation 1.39	3.57 score on a scale Standard Deviation 1.39
Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet Baseline	3.28 score on a scale Standard Deviation 1.62	2.97 score on a scale Standard Deviation 3.57
Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet 24 weeks	4.01 score on a scale Standard Deviation 1.40	3.55 score on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: baseline, 12 weeks and 24 weeks

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

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates Baseline	2.91 score on a scale Standard Deviation 2.45	2.64 score on a scale Standard Deviation 2.04
Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates 12 weeks	3.76 score on a scale Standard Deviation 1.95	3.51 score on a scale Standard Deviation 2.17
Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates 24 weeks	4.42 score on a scale Standard Deviation 1.99	3.43 score on a scale Standard Deviation 2.28

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA)- Exercise Baseline	2.82 score on a scale Standard Deviation 2.09	2.49 score on a scale Standard Deviation 2.06
Summary of Diabetes Self-Care Activities (SDSCA)- Exercise 12 weeks	3.04 score on a scale Standard Deviation 2.24	3.02 score on a scale Standard Deviation 2.33
Summary of Diabetes Self-Care Activities (SDSCA)- Exercise 24 weeks	3.31 score on a scale Standard Deviation 2.10	3.09 score on a scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare Baseline	3.57 score on a scale Standard Deviation 2.30	4.04 score on a scale Standard Deviation 2.42
Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare 12 weeks	4.58 score on a scale Standard Deviation 2.18	4.81 score on a scale Standard Deviation 2.13
Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare 24 weeks	4.70 score on a scale Standard Deviation 2.25	4.85 score on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: 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 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

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=64 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=66 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing 12 weeks	5.00 score on a scale Standard Deviation 2.50	4.92 score on a scale Standard Deviation 2.19
Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing 24 weeks	5.19 score on a scale Standard Deviation 2.33	4.56 score on a scale Standard Deviation 2.53
Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing Baseline	4.68 score on a scale Standard Deviation 2.71	4.94 score on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=63 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking Baseline	2.82 score on a scale Standard Deviation 5.79	2.69 score on a scale Standard Deviation 6.14
Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking 12 weeks	2.13 score on a scale Standard Deviation 5.65	3.03 score on a scale Standard Deviation 6.52
Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking 24 weeks	2.12 score on a scale Standard Deviation 6.45	2.83 score on a scale Standard Deviation 6.74

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=66 Participants Usual care control
Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence Baseline	6.49 score on a scale Standard Deviation 1.17	6.30 score on a scale Standard Deviation 1.50
Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence 12 weeks	6.28 score on a scale Standard Deviation 1.79	6.02 score on a scale Standard Deviation 1.76
Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence 24 weeks	6.45 score on a scale Standard Deviation 1.52	6.28 score on a scale Standard Deviation 1.60

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b Baseline	56.68 score on a scale Standard Deviation 9.30	58.52 score on a scale Standard Deviation 8.64
Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b 12 weeks	54.66 score on a scale Standard Deviation 9.22	57.08 score on a scale Standard Deviation 8.78
Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b 24 weeks	53.97 score on a scale Standard Deviation 10.29	56.84 score on a scale Standard Deviation 8.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Diabetes Self Management Education (DSME) + Mind-STRIDE n=65 Participants Will receive routine diabetes self-management education + the Mind-STRIDE intervention Mind-STRIDE: Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education	DSME Alone n=67 Participants Usual care control
Insomnia Severity Index (ISI) Baseline	11.00 score on a scale Standard Deviation 6.12	11.81 score on a scale Standard Deviation 7.51
Insomnia Severity Index (ISI) 12 weeks	9.20 score on a scale Standard Deviation 7.15	10.34 score on a scale Standard Deviation 6.79
Insomnia Severity Index (ISI) 24 weeks	8.48 score on a scale Standard Deviation 6.48	10.14 score on a scale Standard Deviation 7.16

Adverse Events

Diabetes Self Management Education (DSME) + Mind-STRIDE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DSME Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Monica DiNardo PhD, Primary Investigator

VAPHS, Center for Heath Equity Research and Promotion

Phone: 412 360-2262

Email: monica.dinardo@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place