A Psychological-behavioral Intervention for Physical Activity in Type 2 Diabetes

Study Overview
=================
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: Examine the feasibility and acceptability of an 8-week, telephone-delivered health behavior intervention utilizing PP exercises and MI with systematic goal-setting. Determine whether the PP-MI intervention leads to greater increases in physical activity than the MI-based education intervention in T2D patients. 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.

Official Title
-----------------
A Psychological-behavioral Intervention for Physical Activity in Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Positive Psychology + Motivational Interviewing
* Behavioral: MI-based Health Education Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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: Cognitive impairment precluding consent or meaningful participation. Lack of phone availability. Inability to read/write in English. Additional medical conditions (e.g., severe arthritis) that preclude physical activity. Enrollment in mind-body programs, lifestyle intervention programs (e.g., cardiac rehabilitation), or other clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Psychology + Motivational Interviewing<br>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. | Behavioral: Positive Psychology + Motivational Interviewing<br>* 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).<br>|
| Active Comparator: MI-Based Health Education Intervention<br>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. | Behavioral: MI-based Health Education Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 1-8 | 
| 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. | Weeks 1-8 | 
| 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 1-8 | 
| 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 1-8 | 
| 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. | Change from Baseline to 8 weeks, and Baseline to 16 weeks | 
| Change in Physical Activity | Measured by Actigraph accelerometer, in number of steps per day. | Change from Baseline to 8 weeks, and Baseline to 16 weeks | 
| Change in Sedentary Time | Measured by Actigraph accelerometer, in minutes per day. | Change from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of positive affect. | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of optimism. | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8, and Week 16. | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of depression. | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 and 16 weeks. Higher scores indicate higher levels of anxiety. | Change in score from Baseline to 8 weeks, and Baseline to 16 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 8 weeks, and Baseline to 16 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 8 weeks, and Baseline to 16 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 8 weeks, and Baseline to 16 weeks |