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

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.

• 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 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).
• MI-based Health Education Intervention (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. 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.

Primary outcomes

• 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 outcomes

• 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.
• 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 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.
• 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.

Other outcomes

• 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.
• 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 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.

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Number of PP-MI Sessions Completed by Participants (Primary), Mean, sessions completed: Positive Psychology + Motivational Interviewing 7.4 +/- 1.8
• Ease of PP Component (Secondary), Mean, units on a scale: Positive Psychology + Motivational Interviewing 8.6 +/- 1.8
• Ease of MI Component (Secondary), Mean, units on a scale: Positive Psychology + Motivational Interviewing 8.5 +/- 1.9
• Utility of PP Component (Secondary), Mean, units on a scale: Positive Psychology + Motivational Interviewing 8.8 +/- 1.5
• Utility of MI Component (Secondary), Mean, rating out of 10: Positive Psychology + Motivational Interviewing 8.6 +/- 2.0
• Change in Moderate-Vigorous Physical Activity (Secondary), Mean, minutes/day: Positive Psychology + Motivational Interviewing 15.72 +/- 25.07; MI-based Health Education Intervention 2.26 +/- 11.86
• Change in Physical Activity (Secondary), Mean, steps/day: Positive Psychology + Motivational Interviewing 1848 +/- 3159; MI-based Health Education Intervention 273 +/- 1498
• Change in Sedentary Time (Secondary), Mean, minutes/day: Positive Psychology + Motivational Interviewing -2.66 +/- 66.57; MI-based Health Education Intervention -2.95 +/- 68.71
• Change in Positive Affect (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing 3.36 +/- 4.98; MI-based Health Education Intervention 0.13 +/- 5.81
• Change in Optimism (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing 1.36 +/- 2.80; MI-based Health Education Intervention 1.00 +/- 3.02
• Change in Self-Efficacy for Exercise (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing 7.18 +/- 23.92; MI-based Health Education Intervention -3.00 +/- 20.13
• Change in Depression (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing -0.54 +/- 2.69; MI-based Health Education Intervention -0.97 +/- 2.57
• Change in Anxiety (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing -0.79 +/- 2.08; MI-Based Health Education Intervention -0.73 +/- 2.61
• Change in Resilience (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing -0.43 +/- 2.50; MI-based Health Education Intervention -0.43 +/- 2.10
• Change in Perceived Social Support (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing 0.68 +/- 6.15; MI-based Health Education Intervention -1.77 +/- 13.57
• Change in Diabetes Self-Care (Secondary), Mean, score on a scale: Positive Psychology + Motivational Interviewing 0.91 +/- 1.00; MI-based Health Education Intervention 0.93 +/- 1.08
• Change in Medication Adherence (Other pre specified), Mean, percentage of medication taken: Positive Psychology + Motivational Interviewing 4 +/- 16; MI-based Health Education Intervention 0 +/- 15
• Change in Self-Reported Physical Activity (Other pre specified), Mean, MET minutes per week: Positive Psychology + Motivational Interviewing 1130.56 +/- 2737.04; MI-based Health Education Intervention 606.29 +/- 4098.38
• Change in Physical Function (Other pre specified), Mean, score on a scale: Positive Psychology + Motivational Interviewing 0.46 +/- 5.30; MI-based Health Education Intervention 2.03 +/- 3.91
• Change in Pain-Related Disability (Other pre specified), Mean, score on a scale: Positive Psychology + Motivational Interviewing -1.36 +/- 12.10; MI-based Health Education Intervention -1.27 +/- 13.57
• 5 more outcome measures not shown.

Adverse events

Time frame: 16 weeks

Serious adverse events by term

Other adverse events by term

• Results publication: Zambrano J, Celano CM, Chung WJ, Massey CN, Feig EH, Millstein RA, Healy BC, Wexler DJ, Park ER, Golden J, Huffman JC. Exploring the feasibility and impact of positive psychology-motivational interviewing interventions to promote positive affect and physical activity in type 2 diabetes: design and methods from the BEHOLD-8 and BEHOLD-16 clinical trials. Health Psychol Behav Med. 2020;8(1):398-422. doi: 10.1080/21642850.2020.1815538. Epub 2020 Sep 14. PMID 33763296
• Results publication: Feig EH, Harnedy LE, Celano CM, Huffman JC. Increase in Daily Steps During the Early Phase of a Physical Activity Intervention for Type 2 Diabetes as a Predictor of Intervention Outcome. Int J Behav Med. 2021 Dec;28(6):834-839. doi: 10.1007/s12529-021-09966-0. Epub 2021 Feb 11. PMID 33575971
• Results publication: Huffman JC, Golden J, Massey CN, Feig EH, Chung WJ, Millstein RA, Brown L, Gianangelo T, Healy BC, Wexler DJ, Park ER, Celano CM. A Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity in Type 2 Diabetes: The BEHOLD-8 Controlled Clinical Trial. Psychosom Med. 2020 Sep;82(7):641-649. doi: 10.1097/PSY.0000000000000840. PMID 32665479

• Study Protocol and Statistical Analysis Plan (PDF, 2018-04-18)

• Jeff C Huffman, MD, Principal investigator, Massachusetts General Hospital