Type 2 Diabetes Mellitus
Conditions
Brief summary
The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D).
Detailed description
The investigators will compare a combined positive psychology and motivational interviewing (PP-MI) intervention that is adapted for patients with T2D to a diabetes education intervention (control) in a randomized controlled trial. The investigators will enroll 70 participants, who will be randomized to either a 16-week PP-MI health behavior intervention or an 16-week diabetes education intervention. In this project, the investigators plan to do the following: 1. Examine the feasibility and acceptability of a 16-week, telephone-delivered health behavior intervention utilizing PP exercises and MI with systematic goal-setting. 2. Determine whether the PP-MI intervention leads to greater increases in physical activity than the education intervention in T2D patients. 3. Explore the impact of the PP-MI intervention on other psychological, behavioral, and medical outcomes, compared to the education intervention. Participants will undergo an initial screening visit during which they will meet with study staff in person. At this visit, study eligibility will be confirmed, and eligible and willing participants will be enrolled. Following enrollment, participants will complete self-report measures, and vital signs and A1c will be measured. They then will take home and wear an accelerometer for one week, to measure baseline physical activity. Baseline information about enrolled participants will be obtained from the participants, care providers, and the electronic medical record as required for characterization of the population. This information will include data regarding medical history (type 2 diabetes mellitus), current medical variables (conditions affecting physical activity), medications, and sociodemographic data (age, gender, race/ethnicity, living alone). Participants will undergo a second in-person visit once adequate baseline physical activity data has been obtained. In this visit, accelerometer data will be reviewed to ensure that adequate baseline activity was captured. If so, participants will be randomized to either the PP-MI or diabetes education condition, then begin the study intervention. During this second in-person visit, participants will receive either a PP-MI or diabetes education treatment manual, depending on randomization. For the PP-MI intervention: For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. At subsequent sessions, participants will review the prior week's PP exercise and learn about a new exercise, then will review the prior week's physical activity goal and set a new one. For the diabetes education intervention: Each week, participants will learn about a different health behavior topic related to diabetes health. This includes information about diabetes self-monitoring, medication adherence, having a heart-healthy diet, and being physically active. Participants will complete the remaining sessions by phone approximately weekly over the next 16 weeks. Phone sessions will last approximately 30 minutes, with PP-MI and physical activity assignments completed between phone sessions. PP and MI will be delivered step-wise within sessions (rather than intertwined) based on our experience, participant feedback, and pilot work. If a week is missed, the session will not be skipped, but rather the intervention will be completed sequentially (with participants who miss weeks then missing the final sessions), with the exception of the final visit, which skips to Planning for the Future in all cases. Participants will undergo an in-person follow-up assessment at 16 weeks. At this session, participants will repeat self-report assessments that were administered at baseline. Vital signs and a blood sample will again be collected at this in-person visit. Prior to this assessment, participants will wear an accelerometer for 7 days to measure physical activity. Participants will also undergo a phone follow-up assessment at 24 weeks. During this session over the phone, participants will repeat self-report assessments that were administered at baseline. Finally, prior to this follow-up, participants will wear another accelerometer for 7 days to measure physical activity.
Interventions
Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. PP and MI components will be delivered stepwise within sessions (rather than intertwined).
BEHAVIORALDiabetes Education
Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. T2D. Eligible patients will meet American Diabetes Association (ADA) criteria for T2D (e.g., HbA1c \[A1C\] ≥6.5%, fasting glucose ≥126 mg/d), with diagnosis confirmed by their diabetes clinician and/or medical record review. 2. Low physical activity. Low physical activity will be defined as ≤150 minutes/week of MVPA (corresponding to ADA recommendations for moderate or greater intensity aerobic physical activity). Physical activity will be measured using a brief questionnaire adapted from the International Physical Activity Questionnaire (IPAQ).
Exclusion criteria
1. Cognitive impairment precluding consent or meaningful participation. 2. Lack of phone availability. 3. Inability to read/write in English. 4. Additional medical conditions (e.g., severe arthritis) that preclude physical activity. 5. Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of PP-MI Sessions Completed by Participants | 16 weeks | Measured by number of PP-MI sessions completed by participants in the PP-MI group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utility of PP Component | Weeks 1-16 | Participants in the PP-MI group will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises. |
| Change in Physical Activity | Change from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by Actigraph accelerometer, in number of steps per day. |
| Change in Positive Affect | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of positive affect. |
| Change in Optimism | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of optimism. |
| Change in Self-Efficacy for Exercise | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assess self-efficacy barriers to exercise (Range: 0-90). Higher scores indicate higher efficacy expectations in relation to exercising. This was measured at Baseline, Week 16, and Week 24. |
| Change in Depression | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of depression. |
| Change in Anxiety | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of anxiety. |
| Change in Resilience | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by the Brief Resilience Scale (BRS), a reliable scale which assesses a person's ability to recover from stress despite adversity (Range: 6-30). Higher scores indicate more resilience. |
| Change in Perceived Social Support | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by the Multidimensional Scale of Perceived Social Support (MSPSS), a scale that measures subjectively reported social support (Range: 12-84). Higher scores indicate more subjectively reported social support. |
| Change in Diabetes Self-Care | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more diabetes self-care activities. |
| Change in Sedentary Time | Change from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by Actigraph accelerometer, in minutes per day. |
| Ease of PP Component | Weeks 1-16 | Participants in the PP-MI group will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises. |
| Ease of MI Component | Weeks 1-16 | Participants in the PP-MI group will provide ratings of ease after each MI exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises. |
| Utility of MI Component | Weeks 1-16 | Participants in the PP-MI group will provide ratings of utility after each MI exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises. |
| Change in Moderate-Vigorous Physical Activity | Change from Baseline to 16 weeks, and Baseline to 24 weeks | ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 16 weeks, and 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by the 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS), a well-validated measure of physical function that is highly responsive to changes in a patient's physical function status (Range: 20-100). Higher scores indicate better physical function. |
| Change in Pain-Related Disability | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by the Pain Disability Index (PDI), a well-validated measure of the extent to which pain interferes with different daily activities (Range 0-70). Higher scores indicate greater interference from pain. |
| Change in Weight | Change from Baseline to Week 16 | Measured during in-person visit at baseline and post-intervention. |
| Change in Body Mass Index (BMI) | Change from Baseline to Week 16 | Measured during in-person visit at baseline and post-intervention. |
| Change in Blood Pressure (Systolic) | Change from Baseline to Week 16 | Measured during in-person visit at baseline and post-intervention. |
| Change in Blood Pressure (Diastolic) | Change from Baseline to Week 16 | Measured during in-person visit at baseline and post-intervention. |
| Change in Hemoglobin A1c | Change from Baseline to Week 16 | Measured during in-person visit at baseline and post-intervention. |
| Change in Self-Reported Physical Activity | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assesses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. |
| Change in Medication Adherence | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks | Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 16 weeks and 24 weeks. Higher scores indicate greater levels of medication adherence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Positive Psychology + Motivational Interviewing Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting.
Positive Psychology + Motivational Interviewing: Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. | 35 |
| Diabetes Education Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior related to diabetes health (physical activity, medication adherence, diet).
Diabetes Education: Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Positive Psychology + Motivational Interviewing | Diabetes Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 15 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Continuous | 64.6 years STANDARD_DEVIATION 10.2 | 62.9 years STANDARD_DEVIATION 10.7 | 63.7 years STANDARD_DEVIATION 10.4 |
| Anxiety | 5.37 score on a scale STANDARD_DEVIATION 4.16 | 5.60 score on a scale STANDARD_DEVIATION 4.31 | 5.49 score on a scale STANDARD_DEVIATION 4.21 |
| Blood Pressure (diastolic) | 73.34 millimeters of mercury STANDARD_DEVIATION 8.21 | 74.09 millimeters of mercury STANDARD_DEVIATION 9.37 | 73.71 millimeters of mercury STANDARD_DEVIATION 8.75 |
| Blood Pressure (systolic) | 139.63 millimeters of mercury STANDARD_DEVIATION 11.31 | 138.63 millimeters of mercury STANDARD_DEVIATION 13.97 | 139.13 millimeters of mercury STANDARD_DEVIATION 12.63 |
| Body Mass Index (BMI) | 30.98 kg/m^2 STANDARD_DEVIATION 4.47 | 31.08 kg/m^2 STANDARD_DEVIATION 5.58 | 31.03 kg/m^2 STANDARD_DEVIATION 5.02 |
| Depression | 3.63 score on a scale STANDARD_DEVIATION 3.87 | 4.00 score on a scale STANDARD_DEVIATION 3.61 | 3.81 score on a scale STANDARD_DEVIATION 3.72 |
| Diabetes Self-Care | 3.17 score on a scale STANDARD_DEVIATION 1.02 | 2.27 score on a scale STANDARD_DEVIATION 1.09 | 2.72 score on a scale STANDARD_DEVIATION 1.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 32 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1c | 7.72 mg/dL STANDARD_DEVIATION 1.66 | 7.75 mg/dL STANDARD_DEVIATION 1.56 | 7.73 mg/dL STANDARD_DEVIATION 1.6 |
| Medication Adherence | 91 percentage of medication taken STANDARD_DEVIATION 22 | 93 percentage of medication taken STANDARD_DEVIATION 14 | 92 percentage of medication taken STANDARD_DEVIATION 18 |
| Moderate-Vigorous Physical Activity | 13.66 minutes/day STANDARD_DEVIATION 13.15 | 13.67 minutes/day STANDARD_DEVIATION 12.12 | 13.66 minutes/day STANDARD_DEVIATION 12.55 |
| Optimism | 15.94 score on a scale STANDARD_DEVIATION 5.64 | 17.20 score on a scale STANDARD_DEVIATION 4.73 | 16.57 score on a scale STANDARD_DEVIATION 5.2 |
| Pain-Related Disability | 8.77 score on a scale STANDARD_DEVIATION 10.36 | 13.71 score on a scale STANDARD_DEVIATION 15.15 | 11.20 score on a scale STANDARD_DEVIATION 13.09 |
| Perceived Social Support (MSPSS) | 64.06 score on a scale STANDARD_DEVIATION 18.25 | 63.14 score on a scale STANDARD_DEVIATION 18.25 | 63.60 score on a scale STANDARD_DEVIATION 18.12 |
| Physical Activity | 4706 steps/day STANDARD_DEVIATION 2389 | 4805 steps/day STANDARD_DEVIATION 1993 | 4756 steps/day STANDARD_DEVIATION 2184 |
| Physical Function | 92.77 score on a scale STANDARD_DEVIATION 5.5 | 90.31 score on a scale STANDARD_DEVIATION 10.92 | 91.54 score on a scale STANDARD_DEVIATION 8.67 |
| Positive Affect | 35.74 score on a scale STANDARD_DEVIATION 6.87 | 33.51 score on a scale STANDARD_DEVIATION 7.54 | 34.63 score on a scale STANDARD_DEVIATION 7.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 24 Participants | 30 Participants | 54 Participants |
| Resilience | 17.86 score on a scale STANDARD_DEVIATION 2.32 | 18.06 score on a scale STANDARD_DEVIATION 1.63 | 17.96 score on a scale STANDARD_DEVIATION 1.99 |
| Sedentary Time | 551.40 minutes/day STANDARD_DEVIATION 98.74 | 499.66 minutes/day STANDARD_DEVIATION 78.33 | 525.53 minutes/day STANDARD_DEVIATION 92.23 |
| Self-Efficacy for Exercise | 50.06 score on a scale STANDARD_DEVIATION 19.63 | 55.43 score on a scale STANDARD_DEVIATION 21.66 | 52.74 score on a scale STANDARD_DEVIATION 20.69 |
| Self-Reported Physical Activity | 633.82 MET minutes per week STANDARD_DEVIATION 560.97 | 1914.87 MET minutes per week STANDARD_DEVIATION 4374.98 | 1274.34 MET minutes per week STANDARD_DEVIATION 3162.72 |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
| Weight | 195.10 pounds STANDARD_DEVIATION 34.02 | 194.05 pounds STANDARD_DEVIATION 40.85 | 194.57 pounds STANDARD_DEVIATION 37.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 12 / 35 | 6 / 35 |
| serious Total, serious adverse events | 4 / 35 | 0 / 35 |
Outcome results
Primary
Number of PP-MI Sessions Completed by Participants
Measured by number of PP-MI sessions completed by participants in the PP-MI group.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Number of PP-MI Sessions Completed by Participants | 11 sessions completed | Standard Deviation 4.45 |
Secondary
Change in Anxiety
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of anxiety.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Anxiety | 16 weeks | -1.04 score on a scale | Standard Deviation 3.98 |
| Positive Psychology + Motivational Interviewing | Change in Anxiety | 24 weeks | -1.00 score on a scale | Standard Deviation 3.44 |
| Diabetes Education | Change in Anxiety | 16 weeks | -0.90 score on a scale | Standard Deviation 2.23 |
| Diabetes Education | Change in Anxiety | 24 weeks | -0.96 score on a scale | Standard Deviation 3.2 |
Secondary
Change in Depression
The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of depression.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Depression | 24 weeks | 0.00 score on a scale | Standard Deviation 3.02 |
| Positive Psychology + Motivational Interviewing | Change in Depression | 16 weeks | -0.11 score on a scale | Standard Deviation 3.19 |
| Diabetes Education | Change in Depression | 16 weeks | -0.72 score on a scale | Standard Deviation 1.87 |
| Diabetes Education | Change in Depression | 24 weeks | 0.46 score on a scale | Standard Deviation 2.62 |
Secondary
Change in Diabetes Self-Care
Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more diabetes self-care activities.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed all follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Diabetes Self-Care | 16 weeks | 0.79 score on a scale | Standard Deviation 0.93 |
| Positive Psychology + Motivational Interviewing | Change in Diabetes Self-Care | 24 weeks | 0.97 score on a scale | Standard Deviation 0.92 |
| Diabetes Education | Change in Diabetes Self-Care | 16 weeks | 1.02 score on a scale | Standard Deviation 1.03 |
| Diabetes Education | Change in Diabetes Self-Care | 24 weeks | 1.13 score on a scale | Standard Deviation 1.2 |
Secondary
Change in Moderate-Vigorous Physical Activity
ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline, 16 weeks, and 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
Time frame: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants wore the Actigraph and provided adequate data at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Moderate-Vigorous Physical Activity | 16 weeks | 3.88 minutes/day | Standard Deviation 10.98 |
| Positive Psychology + Motivational Interviewing | Change in Moderate-Vigorous Physical Activity | 24 weeks | 2.75 minutes/day | Standard Deviation 10.31 |
| Diabetes Education | Change in Moderate-Vigorous Physical Activity | 16 weeks | -1.21 minutes/day | Standard Deviation 9.76 |
| Diabetes Education | Change in Moderate-Vigorous Physical Activity | 24 weeks | 0.33 minutes/day | Standard Deviation 12.09 |
Secondary
Change in Optimism
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of optimism.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Optimism | 16 weeks | 2.54 score on a scale | Standard Deviation 4.38 |
| Positive Psychology + Motivational Interviewing | Change in Optimism | 24 weeks | 2.54 score on a scale | Standard Deviation 3.79 |
| Diabetes Education | Change in Optimism | 16 weeks | 0.55 score on a scale | Standard Deviation 3.16 |
| Diabetes Education | Change in Optimism | 24 weeks | 0.43 score on a scale | Standard Deviation 4.86 |
Secondary
Change in Perceived Social Support
Measured by the Multidimensional Scale of Perceived Social Support (MSPSS), a scale that measures subjectively reported social support (Range: 12-84). Higher scores indicate more subjectively reported social support.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Perceived Social Support | 16 weeks | -1.18 score on a scale | Standard Deviation 19.88 |
| Positive Psychology + Motivational Interviewing | Change in Perceived Social Support | 24 weeks | 6.25 score on a scale | Standard Deviation 14.86 |
| Diabetes Education | Change in Perceived Social Support | 16 weeks | 3.83 score on a scale | Standard Deviation 12.62 |
| Diabetes Education | Change in Perceived Social Support | 24 weeks | 5.57 score on a scale | Standard Deviation 15.15 |
Secondary
Change in Physical Activity
Measured by Actigraph accelerometer, in number of steps per day.
Time frame: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants wore the Actigraph and provided adequate data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Physical Activity | 16 weeks | 904 steps/day | Standard Deviation 1206 |
| Positive Psychology + Motivational Interviewing | Change in Physical Activity | 24 weeks | 222 steps/day | Standard Deviation 1410 |
| Diabetes Education | Change in Physical Activity | 16 weeks | -379 steps/day | Standard Deviation 1228 |
| Diabetes Education | Change in Physical Activity | 24 weeks | -290 steps/day | Standard Deviation 1301 |
Secondary
Change in Positive Affect
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks. Higher scores indicate higher levels of positive affect.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Positive Affect | 16 weeks | 1.29 score on a scale | Standard Deviation 5.68 |
| Positive Psychology + Motivational Interviewing | Change in Positive Affect | 24 weeks | 5.54 score on a scale | Standard Deviation 6.09 |
| Diabetes Education | Change in Positive Affect | 16 weeks | 0.41 score on a scale | Standard Deviation 5.13 |
| Diabetes Education | Change in Positive Affect | 24 weeks | 4.21 score on a scale | Standard Deviation 6.65 |
Secondary
Change in Resilience
Measured by the Brief Resilience Scale (BRS), a reliable scale which assesses a person's ability to recover from stress despite adversity (Range: 6-30). Higher scores indicate more resilience.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Resilience | 24 weeks | -0.25 score on a scale | Standard Deviation 2.64 |
| Positive Psychology + Motivational Interviewing | Change in Resilience | 16 weeks | -0.07 score on a scale | Standard Deviation 3.95 |
| Diabetes Education | Change in Resilience | 16 weeks | 0.00 score on a scale | Standard Deviation 2.33 |
| Diabetes Education | Change in Resilience | 24 weeks | 0.64 score on a scale | Standard Deviation 2.33 |
Secondary
Change in Sedentary Time
Measured by Actigraph accelerometer, in minutes per day.
Time frame: Change from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants wore the Actigraph and provided adequate data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Sedentary Time | 24 weeks | -11.84 minutes/day | Standard Deviation 84.61 |
| Positive Psychology + Motivational Interviewing | Change in Sedentary Time | 16 weeks | 19.68 minutes/day | Standard Deviation 138.82 |
| Diabetes Education | Change in Sedentary Time | 16 weeks | 5.78 minutes/day | Standard Deviation 74.75 |
| Diabetes Education | Change in Sedentary Time | 24 weeks | 4.74 minutes/day | Standard Deviation 79.95 |
Secondary
Change in Self-Efficacy for Exercise
Measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assess self-efficacy barriers to exercise (Range: 0-90). Higher scores indicate higher efficacy expectations in relation to exercising. This was measured at Baseline, Week 16, and Week 24.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Self-Efficacy for Exercise | 16 weeks | 12.50 score on a scale | Standard Deviation 22.66 |
| Positive Psychology + Motivational Interviewing | Change in Self-Efficacy for Exercise | 24 weeks | 7.38 score on a scale | Standard Deviation 21.97 |
| Diabetes Education | Change in Self-Efficacy for Exercise | 16 weeks | -9.55 score on a scale | Standard Deviation 25.75 |
| Diabetes Education | Change in Self-Efficacy for Exercise | 24 weeks | -7.81 score on a scale | Standard Deviation 27.47 |
Secondary
Ease of MI Component
Participants in the PP-MI group will provide ratings of ease after each MI exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.
Time frame: Weeks 1-16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Ease of MI Component | 8.40 units on a scale | Standard Deviation 1.83 |
Secondary
Ease of PP Component
Participants in the PP-MI group will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.
Time frame: Weeks 1-16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Ease of PP Component | 8.18 units on a scale | Standard Deviation 1.98 |
Secondary
Utility of MI Component
Participants in the PP-MI group will provide ratings of utility after each MI exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.
Time frame: Weeks 1-16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Utility of MI Component | 8.96 units on a scale | Standard Deviation 1.4 |
Secondary
Utility of PP Component
Participants in the PP-MI group will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.
Time frame: Weeks 1-16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Utility of PP Component | 8.78 units on a scale | Standard Deviation 1.51 |
Other Pre-specified
Change in Blood Pressure (Diastolic)
Measured during in-person visit at baseline and post-intervention.
Time frame: Change from Baseline to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Blood Pressure (Diastolic) | -3.00 millimeters of mercury | Standard Deviation 7.76 |
| Diabetes Education | Change in Blood Pressure (Diastolic) | -0.36 millimeters of mercury | Standard Deviation 11.28 |
Other Pre-specified
Change in Blood Pressure (Systolic)
Measured during in-person visit at baseline and post-intervention.
Time frame: Change from Baseline to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Blood Pressure (Systolic) | -5.52 millimeters of mercury | Standard Deviation 15.99 |
| Diabetes Education | Change in Blood Pressure (Systolic) | -1.08 millimeters of mercury | Standard Deviation 17.21 |
Other Pre-specified
Change in Body Mass Index (BMI)
Measured during in-person visit at baseline and post-intervention.
Time frame: Change from Baseline to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Body Mass Index (BMI) | -0.28 kg/m^2 | Standard Deviation 1.11 |
| Diabetes Education | Change in Body Mass Index (BMI) | 0.00 kg/m^2 | Standard Deviation 0.73 |
Other Pre-specified
Change in Hemoglobin A1c
Measured during in-person visit at baseline and post-intervention.
Time frame: Change from Baseline to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Hemoglobin A1c | 0.10 mg/dL | Standard Deviation 1.09 |
| Diabetes Education | Change in Hemoglobin A1c | 0.10 mg/dL | Standard Deviation 0.44 |
Other Pre-specified
Change in Medication Adherence
Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 16 weeks and 24 weeks. Higher scores indicate greater levels of medication adherence.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Medication Adherence | 16 weeks | 0.7 percentage of medication taken | Standard Deviation 5.4 |
| Positive Psychology + Motivational Interviewing | Change in Medication Adherence | 24 weeks | 2.1 percentage of medication taken | Standard Deviation 4.1 |
| Diabetes Education | Change in Medication Adherence | 16 weeks | 0.3 percentage of medication taken | Standard Deviation 7.8 |
| Diabetes Education | Change in Medication Adherence | 24 weeks | -0.4 percentage of medication taken | Standard Deviation 10.7 |
Other Pre-specified
Change in Pain-Related Disability
Measured by the Pain Disability Index (PDI), a well-validated measure of the extent to which pain interferes with different daily activities (Range 0-70). Higher scores indicate greater interference from pain.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Pain-Related Disability | 16 weeks | 1.11 score on a scale | Standard Deviation 13.68 |
| Positive Psychology + Motivational Interviewing | Change in Pain-Related Disability | 24 weeks | -2.83 score on a scale | Standard Deviation 9.18 |
| Diabetes Education | Change in Pain-Related Disability | 16 weeks | -5.18 score on a scale | Standard Deviation 10.5 |
| Diabetes Education | Change in Pain-Related Disability | 24 weeks | -1.22 score on a scale | Standard Deviation 13.65 |
Other Pre-specified
Change in Physical Function
Measured by the 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS), a well-validated measure of physical function that is highly responsive to changes in a patient's physical function status (Range: 20-100). Higher scores indicate better physical function.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Physical Function | 16 weeks | 0.04 score on a scale | Standard Deviation 5.72 |
| Positive Psychology + Motivational Interviewing | Change in Physical Function | 24 weeks | 2.83 score on a scale | Standard Deviation 4.67 |
| Diabetes Education | Change in Physical Function | 16 weeks | 0.31 score on a scale | Standard Deviation 4.42 |
| Diabetes Education | Change in Physical Function | 24 weeks | 0.96 score on a scale | Standard Deviation 5.27 |
Other Pre-specified
Change in Self-Reported Physical Activity
Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assesses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 16 and 24 weeks.
Time frame: Change in score from Baseline to 16 weeks, and Baseline to 24 weeks
Population: Not all participants completed all follow-up questionnaires at both follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Self-Reported Physical Activity | 16 weeks | 1512.41 MET minutes per week | Standard Deviation 1957.69 |
| Positive Psychology + Motivational Interviewing | Change in Self-Reported Physical Activity | 24 weeks | 912.72 MET minutes per week | Standard Deviation 1096.29 |
| Diabetes Education | Change in Self-Reported Physical Activity | 16 weeks | 96.10 MET minutes per week | Standard Deviation 1704.43 |
| Diabetes Education | Change in Self-Reported Physical Activity | 24 weeks | -87.80 MET minutes per week | Standard Deviation 1585.93 |
Other Pre-specified
Change in Weight
Measured during in-person visit at baseline and post-intervention.
Time frame: Change from Baseline to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Weight | -2.08 pounds | Standard Deviation 5.68 |
| Diabetes Education | Change in Weight | 0.09 pounds | Standard Deviation 4.88 |