Type2 Diabetes
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 versus a motivational interviewing (MI) health education 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 motivational interviewing (MI) health education intervention. The MGH Diabetes Center and MGH primary care clinics will serve as the source of subjects for the study, with patients who have a diagnosis of T2D serving as potential participants. The investigators will enroll 60 participants, who will be randomized to either an 8-week PP-MI health behavior intervention or an 8-week MI-based health education intervention. In this project, the investigators plan to do the following: 1. Examine the feasibility and acceptability of an 8-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 MI-based education intervention in T2D patients. 3. Explore the impact of the PP-MI intervention on other psychological, behavioral, and medical outcomes, compared to the MI-based 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 patients, 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 MI-based health education intervention, then begin the study intervention. During this second in-person visit, participants will receive either a PP-MI or MI-based health 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 MI-based health education intervention: Each week, participants will learn about a different health behavior topic related to diabetes health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics, including medication adherence, having a heart-healthy diet, and being physically active. Participants will complete the remaining sessions by phone approximately weekly over the next 8 weeks. Phone sessions will last approximately 30 minutes, with PP-MI and physical activity assignments completed between phone sessions. PP and MI components 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 call, which skips to Planning for the Future in all cases. Participants will undergo an in-person follow-up assessment at 8 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 an additional 7 days to measure physical activity. Participants will also undergo a phone follow-up assessment at 16 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 instruments 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 8 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 step-wise within sessions (rather than intertwined).
BEHAVIORALMI-based Health Education Intervention
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. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior.
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 | 8 weeks | Measured by number of PP-MI sessions completed by participants in the PP-MI group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utility of MI Component | Weeks 1-8 | 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 Sedentary Time | Change from Baseline to 8 weeks, and Baseline to 16 weeks | Measured by Actigraph accelerometer, in minutes per day. |
| Change in Positive Affect | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of positive affect. |
| Change in Optimism | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of optimism. |
| Change in Self-Efficacy for Exercise | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8, and Week 16. |
| Change in Depression | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of depression. |
| Change in Anxiety | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of anxiety. |
| Change in Resilience | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 weeks, and Baseline to 16 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 8 weeks, and Baseline to 16 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. |
| Ease of PP Component | Weeks 1-8 | 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 1-8 | 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 PP Component | Weeks 1-8 | 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 Moderate-Vigorous Physical Activity | Change from Baseline to 8 weeks, and Baseline to 16 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, 8 weeks, and 16 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. |
| Change in Physical Activity | Change from Baseline to 8 weeks, and Baseline to 16 weeks | Measured by Actigraph accelerometer, in number of steps per day. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Function | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 weeks, and Baseline to 16 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 8 | Measured during in-person visit at baseline and post-intervention. |
| Change in Body Mass Index (BMI) | Change from Baseline to Week 8 | Measured during in-person visit at baseline and post-intervention. |
| Change in Blood Pressure (Systolic) | Change from Baseline to Week 8 | Measured during in-person visit at baseline and post-intervention. |
| Change in Blood Pressure (Diastolic) | Change from Baseline to Week 8 | Measured during in-person visit at baseline and post-intervention. |
| Change in Hemoglobin A1c | Change from Baseline to Week 8 | Measured during in-person visit at baseline and post-intervention. |
| Change in Self-Reported Physical Activity | Change from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. |
| Change in Medication Adherence | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 weeks and 16 weeks. Higher scores indicate greater levels of medication adherence. |
Countries
United States
Participant flow
Pre-assignment details
In order to meet our goal of having 60 participants complete the intervention, we recruited 63 participants in order to account for 3 participants who were Lost to Follow-Up.
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 instruments 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 8 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. | 30 |
| MI-Based Health Education Intervention 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) and will use motivational interviewing techniques to facilitate the consideration of behavior change.
MI-based Health Education Intervention: 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. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Positive Psychology + Motivational Interviewing | Total | MI-Based Health Education Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 60 Participants | 30 Participants |
| Age, Continuous | 65.3 years STANDARD_DEVIATION 10.6 | 64.4 years STANDARD_DEVIATION 10.1 | 63.5 years STANDARD_DEVIATION 9.8 |
| Anxiety | 5.53 score on a scale STANDARD_DEVIATION 4.05 | 5.37 score on a scale STANDARD_DEVIATION 3.86 | 5.20 score on a scale STANDARD_DEVIATION 3.72 |
| Blood Pressure (diastolic) | 75.73 millimeters of mercury STANDARD_DEVIATION 14.44 | 72.97 millimeters of mercury STANDARD_DEVIATION 11.92 | 70.2 millimeters of mercury STANDARD_DEVIATION 8.05 |
| Blood Pressure (systolic) | 142.7 millimeters of mercury STANDARD_DEVIATION 18.75 | 138.07 millimeters of mercury STANDARD_DEVIATION 16.85 | 133.43 millimeters of mercury STANDARD_DEVIATION 13.48 |
| Body Mass Index (BMI) | 31.57 kg/m^2 STANDARD_DEVIATION 6.24 | 31.97 kg/m^2 STANDARD_DEVIATION 5.99 | 32.38 kg/m^2 STANDARD_DEVIATION 5.81 |
| Depression | 3.87 score on a scale STANDARD_DEVIATION 2.99 | 3.78 score on a scale STANDARD_DEVIATION 3.54 | 3.70 score on a scale STANDARD_DEVIATION 4.07 |
| Diabetes Self-Care | 3.05 score on a scale STANDARD_DEVIATION 1.3 | 3.03 score on a scale STANDARD_DEVIATION 1.31 | 3.02 score on a scale STANDARD_DEVIATION 1.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 57 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1c | 7.40 mg/dL STANDARD_DEVIATION 1.51 | 7.57 mg/dL STANDARD_DEVIATION 1.46 | 7.75 mg/dL STANDARD_DEVIATION 1.41 |
| Medication Adherence | 90 percentage of medication taken STANDARD_DEVIATION 20 | 91 percentage of medication taken STANDARD_DEVIATION 19 | 93 percentage of medication taken STANDARD_DEVIATION 19 |
| Moderate-Vigorous Physical Activity | 10.48 minutes/day STANDARD_DEVIATION 9.09 | 12.85 minutes/day STANDARD_DEVIATION 11.96 | 15.21 minutes/day STANDARD_DEVIATION 14.03 |
| Optimism | 23.30 score on a scale STANDARD_DEVIATION 4.68 | 23.28 score on a scale STANDARD_DEVIATION 4.83 | 23.27 score on a scale STANDARD_DEVIATION 5.06 |
| Pain-Related Disability | 9.30 score on a scale STANDARD_DEVIATION 10.81 | 9.02 score on a scale STANDARD_DEVIATION 11.73 | 8.73 score on a scale STANDARD_DEVIATION 12.76 |
| Perceived Social Support | 69.60 score on a scale STANDARD_DEVIATION 12.46 | 69.70 score on a scale STANDARD_DEVIATION 12.38 | 69.80 score on a scale STANDARD_DEVIATION 12.5 |
| Physical Activity | 4339 steps/day STANDARD_DEVIATION 1324 | 4682 steps/day STANDARD_DEVIATION 1980 | 5025 steps/day STANDARD_DEVIATION 2446 |
| Physical Function | 92.27 score on a scale STANDARD_DEVIATION 8.12 | 92.68 score on a scale STANDARD_DEVIATION 7.55 | 93.10 score on a scale STANDARD_DEVIATION 7.04 |
| Positive Affect | 35.00 score on a scale STANDARD_DEVIATION 5.74 | 36.03 score on a scale STANDARD_DEVIATION 7.24 | 37.07 score on a scale STANDARD_DEVIATION 8.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 46 Participants | 21 Participants |
| Resilience | 18.00 score on a scale STANDARD_DEVIATION 2.38 | 18.02 score on a scale STANDARD_DEVIATION 2.1 | 18.03 score on a scale STANDARD_DEVIATION 1.83 |
| Sedentary Time | 524.7 minutes/day STANDARD_DEVIATION 79 | 533.2 minutes/day STANDARD_DEVIATION 90.2 | 541.6 minutes/day STANDARD_DEVIATION 100.7 |
| Self-Efficacy for Exercise | 54.93 score on a scale STANDARD_DEVIATION 25.21 | 55.78 score on a scale STANDARD_DEVIATION 21.35 | 56.63 score on a scale STANDARD_DEVIATION 17.04 |
| Self-Reported Physical Activity | 1165.13 MET minutes per week STANDARD_DEVIATION 2132.54 | 1091.36 MET minutes per week STANDARD_DEVIATION 2558.28 | 1017.59 MET minutes per week STANDARD_DEVIATION 2959.11 |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 29 Participants | 15 Participants |
| Weight | 196.47 pounds STANDARD_DEVIATION 41.68 | 198.76 pounds STANDARD_DEVIATION 41.21 | 201.05 pounds STANDARD_DEVIATION 41.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 5 / 30 | 5 / 30 |
| serious Total, serious adverse events | 1 / 30 | 0 / 30 |
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: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Number of PP-MI Sessions Completed by Participants | 7.4 sessions completed | Standard Deviation 1.8 |
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 8 and 16 weeks. Higher scores indicate higher levels of anxiety.
Time frame: Change in score from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | -0.79 score on a scale | Standard Deviation 2.08 |
| Positive Psychology + Motivational Interviewing | Change in Anxiety | 16 weeks | -0.27 score on a scale | Standard Deviation 2.21 |
| MI-based Health Education Intervention | Change in Anxiety | 8 weeks | -0.73 score on a scale | Standard Deviation 2.61 |
| MI-based Health Education Intervention | Change in Anxiety | 16 weeks | -0.57 score on a scale | Standard Deviation 3.7 |
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 8 and 16 weeks. Higher scores indicate higher levels of depression.
Time frame: Change in score from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | -0.54 score on a scale | Standard Deviation 2.69 |
| Positive Psychology + Motivational Interviewing | Change in Depression | 16 weeks | -0.83 score on a scale | Standard Deviation 2.7 |
| MI-based Health Education Intervention | Change in Depression | 8 weeks | -0.97 score on a scale | Standard Deviation 2.57 |
| MI-based Health Education Intervention | Change in Depression | 16 weeks | -0.07 score on a scale | Standard Deviation 2.69 |
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 8 weeks, and Baseline to 16 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 | 8 weeks | 0.91 score on a scale | Standard Deviation 1 |
| Positive Psychology + Motivational Interviewing | Change in Diabetes Self-Care | 16 weeks | 0.87 score on a scale | Standard Deviation 1.16 |
| MI-based Health Education Intervention | Change in Diabetes Self-Care | 8 weeks | 0.93 score on a scale | Standard Deviation 1.08 |
| MI-based Health Education Intervention | Change in Diabetes Self-Care | 16 weeks | 1.11 score on a scale | Standard Deviation 1.21 |
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, 8 weeks, and 16 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
Time frame: Change from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | 15.72 minutes/day | Standard Deviation 25.07 |
| Positive Psychology + Motivational Interviewing | Change in Moderate-Vigorous Physical Activity | 16 weeks | 10.05 minutes/day | Standard Deviation 23.73 |
| MI-based Health Education Intervention | Change in Moderate-Vigorous Physical Activity | 8 weeks | 2.26 minutes/day | Standard Deviation 11.86 |
| MI-based Health Education Intervention | Change in Moderate-Vigorous Physical Activity | 16 weeks | 2.47 minutes/day | Standard Deviation 8.87 |
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 8 and 16 weeks. Higher scores indicate higher levels of optimism.
Time frame: Change in score from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | 1.36 score on a scale | Standard Deviation 2.8 |
| Positive Psychology + Motivational Interviewing | Change in Optimism | 16 weeks | 1.03 score on a scale | Standard Deviation 2.57 |
| MI-based Health Education Intervention | Change in Optimism | 8 weeks | 1.00 score on a scale | Standard Deviation 3.02 |
| MI-based Health Education Intervention | Change in Optimism | 16 weeks | 1.61 score on a scale | Standard Deviation 3.89 |
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 8 weeks, and Baseline to 16 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 | 8 weeks | 0.68 score on a scale | Standard Deviation 6.15 |
| Positive Psychology + Motivational Interviewing | Change in Perceived Social Support | 16 weeks | 3.13 score on a scale | Standard Deviation 7.2 |
| MI-based Health Education Intervention | Change in Perceived Social Support | 8 weeks | -1.77 score on a scale | Standard Deviation 13.57 |
| MI-based Health Education Intervention | Change in Perceived Social Support | 16 weeks | 0.36 score on a scale | Standard Deviation 9.94 |
Secondary
Change in Physical Activity
Measured by Actigraph accelerometer, in number of steps per day.
Time frame: Change from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | 1848 steps/day | Standard Deviation 3159 |
| Positive Psychology + Motivational Interviewing | Change in Physical Activity | 16 weeks | 969 steps/day | Standard Deviation 3377 |
| MI-based Health Education Intervention | Change in Physical Activity | 8 weeks | 273 steps/day | Standard Deviation 1498 |
| MI-based Health Education Intervention | Change in Physical Activity | 16 weeks | 171 steps/day | Standard Deviation 1159 |
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 8 and 16 weeks. Higher scores indicate higher levels of positive affect.
Time frame: Change in score from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | 3.36 score on a scale | Standard Deviation 4.98 |
| Positive Psychology + Motivational Interviewing | Change in Positive Affect | 16 weeks | 5.80 score on a scale | Standard Deviation 7.17 |
| MI-based Health Education Intervention | Change in Positive Affect | 8 weeks | 0.13 score on a scale | Standard Deviation 5.81 |
| MI-based Health Education Intervention | Change in Positive Affect | 16 weeks | 2.61 score on a scale | Standard Deviation 5.88 |
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 8 weeks, and Baseline to 16 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 | 8 weeks | -0.43 score on a scale | Standard Deviation 2.5 |
| Positive Psychology + Motivational Interviewing | Change in Resilience | 16 weeks | 0.37 score on a scale | Standard Deviation 2.82 |
| MI-based Health Education Intervention | Change in Resilience | 8 weeks | -0.43 score on a scale | Standard Deviation 2.1 |
| MI-based Health Education Intervention | Change in Resilience | 16 weeks | -0.32 score on a scale | Standard Deviation 2.72 |
Secondary
Change in Sedentary Time
Measured by Actigraph accelerometer, in minutes per day.
Time frame: Change from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | -2.66 minutes/day | Standard Deviation 66.57 |
| Positive Psychology + Motivational Interviewing | Change in Sedentary Time | 16 weeks | 2.83 minutes/day | Standard Deviation 60.78 |
| MI-based Health Education Intervention | Change in Sedentary Time | 8 weeks | -2.95 minutes/day | Standard Deviation 68.71 |
| MI-based Health Education Intervention | Change in Sedentary Time | 16 weeks | -6.42 minutes/day | Standard Deviation 68.46 |
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 8, and Week 16.
Time frame: Change in score from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | 7.18 score on a scale | Standard Error 23.92 |
| Positive Psychology + Motivational Interviewing | Change in Self-Efficacy for Exercise | 16 weeks | 6.93 score on a scale | Standard Error 21.26 |
| MI-based Health Education Intervention | Change in Self-Efficacy for Exercise | 8 weeks | -3.00 score on a scale | Standard Error 20.13 |
| MI-based Health Education Intervention | Change in Self-Efficacy for Exercise | 16 weeks | -7.89 score on a scale | Standard Error 19 |
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 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Ease of MI Component | 8.5 units on a scale | Standard Deviation 1.9 |
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 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Ease of PP Component | 8.6 units on a scale | Standard Deviation 1.8 |
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 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Utility of MI Component | 8.6 rating out of 10 | Standard Deviation 2 |
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 1-8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Utility of PP Component | 8.8 units on a scale | Standard Deviation 1.5 |
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 8
Population: Not all participants attended the follow-up visit at Week 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Blood Pressure (Diastolic) | -1.33 millimeters of mercury | Standard Deviation 13.54 |
| MI-based Health Education Intervention | Change in Blood Pressure (Diastolic) | 1.86 millimeters of mercury | Standard Deviation 6.99 |
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 8
Population: Not all participants attended the follow-up visit at Week 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Blood Pressure (Systolic) | -2.48 millimeters of mercury | Standard Deviation 16.2 |
| MI-based Health Education Intervention | Change in Blood Pressure (Systolic) | 0.90 millimeters of mercury | Standard Deviation 11.77 |
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 8
Population: Not all participants attended the follow-up visit at Week 8, and not all of those participants who did had their weight taken.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Body Mass Index (BMI) | 0.04 kg/m^2 | Standard Deviation 0.8 |
| MI-based Health Education Intervention | Change in Body Mass Index (BMI) | -0.27 kg/m^2 | Standard Deviation 0.99 |
Other Pre-specified
Change in Hemoglobin A1c
Measured during in-person visit at baseline and post-intervention.
Time frame: Change from Baseline to Week 8
Population: Not all participants attended the follow-up visit at Week 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Hemoglobin A1c | -0.21 mg/dL | Standard Deviation 0.57 |
| MI-based Health Education Intervention | Change in Hemoglobin A1c | -0.10 mg/dL | Standard Deviation 1.25 |
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 8 weeks and 16 weeks. Higher scores indicate greater levels of medication adherence.
Time frame: Change in score from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | 4 percentage of medication taken | Standard Deviation 16 |
| Positive Psychology + Motivational Interviewing | Change in Medication Adherence | 16 weeks | 3 percentage of medication taken | Standard Deviation 20 |
| MI-based Health Education Intervention | Change in Medication Adherence | 8 weeks | 0 percentage of medication taken | Standard Deviation 15 |
| MI-based Health Education Intervention | Change in Medication Adherence | 16 weeks | 1 percentage of medication taken | Standard Deviation 21 |
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 8 weeks, and Baseline to 16 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 | 8 weeks | -1.36 score on a scale | Standard Deviation 12.1 |
| Positive Psychology + Motivational Interviewing | Change in Pain-Related Disability | 16 weeks | -2.83 score on a scale | Standard Deviation 11.47 |
| MI-based Health Education Intervention | Change in Pain-Related Disability | 8 weeks | -1.27 score on a scale | Standard Deviation 13.57 |
| MI-based Health Education Intervention | Change in Pain-Related Disability | 16 weeks | -1.00 score on a scale | Standard Deviation 8.55 |
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 8 weeks, and Baseline to 16 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 | 8 weeks | 0.46 score on a scale | Standard Deviation 5.3 |
| Positive Psychology + Motivational Interviewing | Change in Physical Function | 16 weeks | 2.83 score on a scale | Standard Deviation 5.95 |
| MI-based Health Education Intervention | Change in Physical Function | 8 weeks | 2.03 score on a scale | Standard Deviation 3.91 |
| MI-based Health Education Intervention | Change in Physical Function | 16 weeks | 1.93 score on a scale | Standard Deviation 4.85 |
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 8 and 16 weeks.
Time frame: Change from Baseline to 8 weeks, and Baseline to 16 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 | 8 weeks | 1130.56 MET minutes per week | Standard Deviation 2737.04 |
| Positive Psychology + Motivational Interviewing | Change in Self-Reported Physical Activity | 16 weeks | 799.04 MET minutes per week | Standard Deviation 2753.9 |
| MI-based Health Education Intervention | Change in Self-Reported Physical Activity | 8 weeks | 606.29 MET minutes per week | Standard Deviation 4098.38 |
| MI-based Health Education Intervention | Change in Self-Reported Physical Activity | 16 weeks | 1090.85 MET minutes per week | Standard Deviation 1544.04 |
Other Pre-specified
Change in Weight
Measured during in-person visit at baseline and post-intervention.
Time frame: Change from Baseline to Week 8
Population: Not all participants attended the follow-up visit at Week 8, and not all of those participants who did had their weight taken.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Change in Weight | -1.10 pounds | Standard Deviation 4.91 |
| MI-based Health Education Intervention | Change in Weight | -1.43 pounds | Standard Deviation 5.78 |