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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Experimental | 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. |
|
| Diabetes Education | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of PP-MI Sessions Completed by Participants | Measured by number of PP-MI sessions completed by participants in the PP-MI group. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 1-16 |
| Ease of MI Component |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff C Huffman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of PP-MI Sessions Completed by Participants | Measured by number of PP-MI sessions completed by participants in the PP-MI group. | Posted | Mean | Standard Deviation | sessions completed | 16 weeks |
|
24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg infection | Infections and infestations | Non-systematic Assessment | Participant reported having been hospitalized due to a leg infection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unexpected hypoglycemia | Endocrine disorders | Non-systematic Assessment | One participant in the PP-MI group reported one episode of hypoglycemia; one participant in the Diabetes Education group reported one episode of hypoglycemia, and another participant in the Diabetes Education reported three episodes of hypoglycemia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeff Huffman | Massachusetts General Hospital | 617-724-2910 | JHUFFMAN@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2018 | May 1, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000080032 | Psychology, Positive |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D037001 | Directive Counseling |
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|
| Diabetes Education | Behavioral | 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. |
|
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. |
| Weeks 1-16 |
| 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. | Weeks 1-16 |
| 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. | Weeks 1-16 |
| 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. | Change from Baseline to 16 weeks, and Baseline to 24 weeks |
| Change in Physical Activity | Measured by Actigraph accelerometer, in number of steps per day. | Change from Baseline to 16 weeks, and Baseline to 24 weeks |
| Change in Sedentary Time | Measured by Actigraph accelerometer, in minutes per day. | Change from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| 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. | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
| Change in Weight | Measured during in-person visit at baseline and post-intervention. | Change from Baseline to Week 16 |
| Change in Body Mass Index (BMI) | Measured during in-person visit at baseline and post-intervention. | Change from Baseline to Week 16 |
| Change in Blood Pressure (Systolic) | Measured during in-person visit at baseline and post-intervention. | Change from Baseline to Week 16 |
| Change in Blood Pressure (Diastolic) | Measured during in-person visit at baseline and post-intervention. | Change from Baseline to Week 16 |
| Change in Hemoglobin A1c | Measured during in-person visit at baseline and post-intervention. | Change from Baseline to Week 16 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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, Week 16, and Week 24 to assess the feasibility of doing so and to ensure adequate capture of physical activity. | Mean | Standard Deviation | minutes/day |
|
| Physical Activity | Measured by Actigraph accelerometer, in number of steps per day. | Mean | Standard Deviation | steps/day |
|
| Sedentary Time | Measured by Actigraph accelerometer, in minutes per day. | Mean | Standard Deviation | minutes/day |
|
| 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). Higher scores indicate higher levels of positive affect. | Mean | Standard Deviation | score on a scale |
|
| Optimism | Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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). Higher scores indicate higher levels of depression. | Mean | Standard Deviation | score on a scale |
|
| 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). Higher scores indicate higher levels of anxiety. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| Perceived Social Support (MSPSS) | 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. Higher scores indicate greater levels of medication adherence. | Mean | Standard Deviation | percentage of medication taken |
|
| 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. | Mean | Standard Deviation | MET minutes per week |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | One participant did not complete this measure at baseline. | Mean | Standard Deviation | score on a scale |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Blood Pressure (systolic) | Mean | Standard Deviation | millimeters of mercury |
|
| Blood Pressure (diastolic) | Mean | Standard Deviation | millimeters of mercury |
|
| Hemoglobin A1c | Mean | Standard Deviation | mg/dL |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1-16 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1-16 |
|
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|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1-16 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1-16 |
|
|
|
| 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. | Not all participants wore the Actigraph and provided adequate data at both follow-up time points. | Posted | Mean | Standard Deviation | minutes/day | Change from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| Secondary | Change in Physical Activity | Measured by Actigraph accelerometer, in number of steps per day. | Not all participants wore the Actigraph and provided adequate data. | Posted | Mean | Standard Deviation | steps/day | Change from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| Secondary | Change in Sedentary Time | Measured by Actigraph accelerometer, in minutes per day. | Not all participants wore the Actigraph and provided adequate data. | Posted | Mean | Standard Deviation | minutes/day | Change from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed all follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | percentage of medication taken | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
|
|
| 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. | Not all participants completed all follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | MET minutes per week | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
|
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| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
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| 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. | Not all participants completed follow-up questionnaires at both follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 16 weeks, and Baseline to 24 weeks |
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| Other Pre-specified | Change in Weight | Measured during in-person visit at baseline and post-intervention. | Posted | Mean | Standard Deviation | pounds | Change from Baseline to Week 16 |
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| Other Pre-specified | Change in Body Mass Index (BMI) | Measured during in-person visit at baseline and post-intervention. | Posted | Mean | Standard Deviation | kg/m^2 | Change from Baseline to Week 16 |
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| Other Pre-specified | Change in Blood Pressure (Systolic) | Measured during in-person visit at baseline and post-intervention. | Posted | Mean | Standard Deviation | millimeters of mercury | Change from Baseline to Week 16 |
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| Other Pre-specified | Change in Blood Pressure (Diastolic) | Measured during in-person visit at baseline and post-intervention. | Posted | Mean | Standard Deviation | millimeters of mercury | Change from Baseline to Week 16 |
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| Other Pre-specified | Change in Hemoglobin A1c | Measured during in-person visit at baseline and post-intervention. | Posted | Mean | Standard Deviation | mg/dL | Change from Baseline to Week 16 |
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|
| 0 |
| 35 |
| 4 |
| 35 |
| 12 |
| 35 |
| EG001 | 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. | 0 | 35 | 0 | 35 | 6 | 35 |
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| Unexpected Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | Two participants were hospitalized for atrial fibrillation. |
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| Unexpected acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant was hospitalized for acute respiratory failure. |
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| Cat bite | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant went to the ED because of a cat bite. |
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| Unexpected abdominal pain and diarrhea | General disorders | Non-systematic Assessment | Participant went to an urgent care clinic due to abdominal pain and diarrhea. |
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| Unexpected nose bleed | General disorders | Non-systematic Assessment | Participant went to the ED due to a nose bleed that lasted more than 30 minutes. |
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| Unexpected ear fullness | Ear and labyrinth disorders | Non-systematic Assessment | Participant went to the ED due to ear fullness. |
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| Unexpected dizziness and abdominal pain | General disorders | Non-systematic Assessment | Participant went to the ED due to dizziness and abdominal pain. |
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| Unexpected fall | General disorders | Non-systematic Assessment | Three participants reported falls. Two participants reported having experienced a fall while going about their daily activities, and one participant reported having experienced three separate falls while going about their daily activities. |
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| Unexpected leg cramps | General disorders | Non-systematic Assessment | Two participants reported experiencing leg cramps while exercising. |
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| Unexpected kidney stone | General disorders | Non-systematic Assessment | Participant went to the ED because of a kidney stone. |
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| Unexpected flank pain | General disorders | Non-systematic Assessment | Participant went to the ED due to flank pain caused by recent kidney stone. |
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| Unexpected gastrointestinal problems | Gastrointestinal disorders | Non-systematic Assessment | Participant reported having an upset stomach and loose stools after starting a new medication prescribed by their primary care physician. |
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| Unexpected shortness of breath | General disorders | Non-systematic Assessment | Participant went to the ED due to shortness of breath. |
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| Unexpected ankle injury | General disorders | Non-systematic Assessment | Participant reported having torn a ligament in their ankle. |
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| Unexpected episode of high blood pressure | General disorders | Non-systematic Assessment | Participant went to the ED due to an episode of high blood pressure. |
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Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
|
| 24 weeks |
|
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