Trial Outcomes & Findings for A Psychological-behavioral Intervention for Physical Activity in Type 2 Diabetes (NCT NCT03150199)

NCT ID: NCT03150199

Last Updated: 2020-05-19

Results Overview

Measured by number of PP-MI sessions completed by participants in the PP-MI group.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2020-05-19

Participant Flow

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-Based Health Education Intervention n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	65.3 years STANDARD_DEVIATION 10.6 • n=5 Participants	63.5 years STANDARD_DEVIATION 9.8 • n=7 Participants	64.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Physical Activity	4339 steps/day STANDARD_DEVIATION 1324 • n=5 Participants	5025 steps/day STANDARD_DEVIATION 2446 • n=7 Participants	4682 steps/day STANDARD_DEVIATION 1980 • n=5 Participants
Moderate-Vigorous Physical Activity	10.48 minutes/day STANDARD_DEVIATION 9.09 • n=5 Participants	15.21 minutes/day STANDARD_DEVIATION 14.03 • n=7 Participants	12.85 minutes/day STANDARD_DEVIATION 11.96 • n=5 Participants
Sedentary Time	524.7 minutes/day STANDARD_DEVIATION 79.0 • n=5 Participants	541.6 minutes/day STANDARD_DEVIATION 100.7 • n=7 Participants	533.2 minutes/day STANDARD_DEVIATION 90.2 • n=5 Participants
Positive Affect	35.00 score on a scale STANDARD_DEVIATION 5.74 • n=5 Participants	37.07 score on a scale STANDARD_DEVIATION 8.46 • n=7 Participants	36.03 score on a scale STANDARD_DEVIATION 7.24 • n=5 Participants
Optimism	23.30 score on a scale STANDARD_DEVIATION 4.68 • n=5 Participants	23.27 score on a scale STANDARD_DEVIATION 5.06 • n=7 Participants	23.28 score on a scale STANDARD_DEVIATION 4.83 • n=5 Participants
Self-Efficacy for Exercise	54.93 score on a scale STANDARD_DEVIATION 25.21 • n=5 Participants	56.63 score on a scale STANDARD_DEVIATION 17.04 • n=7 Participants	55.78 score on a scale STANDARD_DEVIATION 21.35 • n=5 Participants
Depression	3.87 score on a scale STANDARD_DEVIATION 2.99 • n=5 Participants	3.70 score on a scale STANDARD_DEVIATION 4.07 • n=7 Participants	3.78 score on a scale STANDARD_DEVIATION 3.54 • n=5 Participants
Anxiety	5.53 score on a scale STANDARD_DEVIATION 4.05 • n=5 Participants	5.20 score on a scale STANDARD_DEVIATION 3.72 • n=7 Participants	5.37 score on a scale STANDARD_DEVIATION 3.86 • n=5 Participants
Resilience	18.00 score on a scale STANDARD_DEVIATION 2.38 • n=5 Participants	18.03 score on a scale STANDARD_DEVIATION 1.83 • n=7 Participants	18.02 score on a scale STANDARD_DEVIATION 2.10 • n=5 Participants
Perceived Social Support	69.60 score on a scale STANDARD_DEVIATION 12.46 • n=5 Participants	69.80 score on a scale STANDARD_DEVIATION 12.50 • n=7 Participants	69.70 score on a scale STANDARD_DEVIATION 12.38 • n=5 Participants
Diabetes Self-Care	3.05 score on a scale STANDARD_DEVIATION 1.30 • n=5 Participants	3.02 score on a scale STANDARD_DEVIATION 1.35 • n=7 Participants	3.03 score on a scale STANDARD_DEVIATION 1.31 • n=5 Participants
Medication Adherence	90 percentage of medication taken STANDARD_DEVIATION 20 • n=5 Participants	93 percentage of medication taken STANDARD_DEVIATION 19 • n=7 Participants	91 percentage of medication taken STANDARD_DEVIATION 19 • n=5 Participants
Self-Reported Physical Activity	1165.13 MET minutes per week STANDARD_DEVIATION 2132.54 • n=5 Participants	1017.59 MET minutes per week STANDARD_DEVIATION 2959.11 • n=7 Participants	1091.36 MET minutes per week STANDARD_DEVIATION 2558.28 • n=5 Participants
Physical Function	92.27 score on a scale STANDARD_DEVIATION 8.12 • n=5 Participants	93.10 score on a scale STANDARD_DEVIATION 7.04 • n=7 Participants	92.68 score on a scale STANDARD_DEVIATION 7.55 • n=5 Participants
Pain-Related Disability	9.30 score on a scale STANDARD_DEVIATION 10.81 • n=5 Participants	8.73 score on a scale STANDARD_DEVIATION 12.76 • n=7 Participants	9.02 score on a scale STANDARD_DEVIATION 11.73 • n=5 Participants
Weight	196.47 pounds STANDARD_DEVIATION 41.68 • n=5 Participants	201.05 pounds STANDARD_DEVIATION 41.31 • n=7 Participants	198.76 pounds STANDARD_DEVIATION 41.21 • n=5 Participants
Body Mass Index (BMI)	31.57 kg/m^2 STANDARD_DEVIATION 6.24 • n=5 Participants	32.38 kg/m^2 STANDARD_DEVIATION 5.81 • n=7 Participants	31.97 kg/m^2 STANDARD_DEVIATION 5.99 • n=5 Participants
Blood Pressure (systolic)	142.7 millimeters of mercury STANDARD_DEVIATION 18.75 • n=5 Participants	133.43 millimeters of mercury STANDARD_DEVIATION 13.48 • n=7 Participants	138.07 millimeters of mercury STANDARD_DEVIATION 16.85 • n=5 Participants
Blood Pressure (diastolic)	75.73 millimeters of mercury STANDARD_DEVIATION 14.44 • n=5 Participants	70.2 millimeters of mercury STANDARD_DEVIATION 8.05 • n=7 Participants	72.97 millimeters of mercury STANDARD_DEVIATION 11.92 • n=5 Participants
Hemoglobin A1c	7.40 mg/dL STANDARD_DEVIATION 1.51 • n=5 Participants	7.75 mg/dL STANDARD_DEVIATION 1.41 • n=7 Participants	7.57 mg/dL STANDARD_DEVIATION 1.46 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Measured by number of PP-MI sessions completed by participants in the PP-MI group.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	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.
Number of PP-MI Sessions Completed by Participants	7.4 sessions completed Standard Deviation 1.8	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	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.
Ease of PP Component	8.6 units on a scale Standard Deviation 1.8	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	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.
Ease of MI Component	8.5 units on a scale Standard Deviation 1.9	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	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.
Utility of PP Component	8.8 units on a scale Standard Deviation 1.5	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	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.
Utility of MI Component	8.6 rating out of 10 Standard Deviation 2.0	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=29 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Moderate-Vigorous Physical Activity 8 weeks	15.72 minutes/day Standard Deviation 25.07	2.26 minutes/day Standard Deviation 11.86
Change in Moderate-Vigorous Physical Activity 16 weeks	10.05 minutes/day Standard Deviation 23.73	2.47 minutes/day Standard Deviation 8.87

SECONDARY outcome

Timeframe: Change from Baseline to 8 weeks, and Baseline to 16 weeks

Population: Not all participants wore the Actigraph and provided adequate data.

Measured by Actigraph accelerometer, in number of steps per day.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=29 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Physical Activity 8 weeks	1848 steps/day Standard Deviation 3159	273 steps/day Standard Deviation 1498
Change in Physical Activity 16 weeks	969 steps/day Standard Deviation 3377	171 steps/day Standard Deviation 1159

SECONDARY outcome

Timeframe: Change from Baseline to 8 weeks, and Baseline to 16 weeks

Population: Not all participants wore the Actigraph and provided adequate data.

Measured by Actigraph accelerometer, in minutes per day.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=29 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Sedentary Time 16 weeks	2.83 minutes/day Standard Deviation 60.78	-6.42 minutes/day Standard Deviation 68.46
Change in Sedentary Time 8 weeks	-2.66 minutes/day Standard Deviation 66.57	-2.95 minutes/day Standard Deviation 68.71

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Positive Affect 8 weeks	3.36 score on a scale Standard Deviation 4.98	0.13 score on a scale Standard Deviation 5.81
Change in Positive Affect 16 weeks	5.80 score on a scale Standard Deviation 7.17	2.61 score on a scale Standard Deviation 5.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Optimism 8 weeks	1.36 score on a scale Standard Deviation 2.80	1.00 score on a scale Standard Deviation 3.02
Change in Optimism 16 weeks	1.03 score on a scale Standard Deviation 2.57	1.61 score on a scale Standard Deviation 3.89

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Self-Efficacy for Exercise 8 weeks	7.18 score on a scale Standard Error 23.92	-3.00 score on a scale Standard Error 20.13
Change in Self-Efficacy for Exercise 16 weeks	6.93 score on a scale Standard Error 21.26	-7.89 score on a scale Standard Error 19.00

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Depression 8 weeks	-0.54 score on a scale Standard Deviation 2.69	-0.97 score on a scale Standard Deviation 2.57
Change in Depression 16 weeks	-0.83 score on a scale Standard Deviation 2.70	-0.07 score on a scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Anxiety 8 weeks	-0.79 score on a scale Standard Deviation 2.08	-0.73 score on a scale Standard Deviation 2.61
Change in Anxiety 16 weeks	-0.27 score on a scale Standard Deviation 2.21	-0.57 score on a scale Standard Deviation 3.70

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Resilience 8 weeks	-0.43 score on a scale Standard Deviation 2.50	-0.43 score on a scale Standard Deviation 2.10
Change in Resilience 16 weeks	0.37 score on a scale Standard Deviation 2.82	-0.32 score on a scale Standard Deviation 2.72

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Perceived Social Support 8 weeks	0.68 score on a scale Standard Deviation 6.15	-1.77 score on a scale Standard Deviation 13.57
Change in Perceived Social Support 16 weeks	3.13 score on a scale Standard Deviation 7.20	0.36 score on a scale Standard Deviation 9.94

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Diabetes Self-Care 8 weeks	0.91 score on a scale Standard Deviation 1.00	0.93 score on a scale Standard Deviation 1.08
Change in Diabetes Self-Care 16 weeks	0.87 score on a scale Standard Deviation 1.16	1.11 score on a scale Standard Deviation 1.21

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Medication Adherence 8 weeks	4 percentage of medication taken Standard Deviation 16	0 percentage of medication taken Standard Deviation 15
Change in Medication Adherence 16 weeks	3 percentage of medication taken Standard Deviation 20	1 percentage of medication taken Standard Deviation 21

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Self-Reported Physical Activity 8 weeks	1130.56 MET minutes per week Standard Deviation 2737.04	606.29 MET minutes per week Standard Deviation 4098.38
Change in Self-Reported Physical Activity 16 weeks	799.04 MET minutes per week Standard Deviation 2753.90	1090.85 MET minutes per week Standard Deviation 1544.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Physical Function 8 weeks	0.46 score on a scale Standard Deviation 5.30	2.03 score on a scale Standard Deviation 3.91
Change in Physical Function 16 weeks	2.83 score on a scale Standard Deviation 5.95	1.93 score on a scale Standard Deviation 4.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=30 Participants 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.	MI-based Health Education Intervention n=30 Participants 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.
Change in Pain-Related Disability 8 weeks	-1.36 score on a scale Standard Deviation 12.10	-1.27 score on a scale Standard Deviation 13.57
Change in Pain-Related Disability 16 weeks	-2.83 score on a scale Standard Deviation 11.47	-1.00 score on a scale Standard Deviation 8.55

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=25 Participants 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.	MI-based Health Education Intervention n=28 Participants 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.
Change in Weight	-1.10 pounds Standard Deviation 4.91	-1.43 pounds Standard Deviation 5.78

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=25 Participants 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.	MI-based Health Education Intervention n=28 Participants 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.
Change in Body Mass Index (BMI)	0.04 kg/m^2 Standard Deviation 0.80	-0.27 kg/m^2 Standard Deviation 0.99

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 8

Population: Not all participants attended the follow-up visit at Week 8.

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=27 Participants 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.	MI-based Health Education Intervention n=29 Participants 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.
Change in Blood Pressure (Systolic)	-2.48 millimeters of mercury Standard Deviation 16.20	0.90 millimeters of mercury Standard Deviation 11.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 8

Population: Not all participants attended the follow-up visit at Week 8.

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=27 Participants 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.	MI-based Health Education Intervention n=29 Participants 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.
Change in Blood Pressure (Diastolic)	-1.33 millimeters of mercury Standard Deviation 13.54	1.86 millimeters of mercury Standard Deviation 6.99

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline to Week 8

Population: Not all participants attended the follow-up visit at Week 8.

Measured during in-person visit at baseline and post-intervention.

Outcome measures

Measure	Positive Psychology + Motivational Interviewing n=27 Participants 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.	MI-based Health Education Intervention n=29 Participants 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.
Change in Hemoglobin A1c	-0.21 mg/dL Standard Deviation 0.57	-0.10 mg/dL Standard Deviation 1.25

Adverse Events

Positive Psychology + Motivational Interviewing

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

MI-based Health Educational Intervention

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Positive Psychology + Motivational Interviewing n=30 participants at risk 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.	MI-based Health Educational Intervention n=30 participants at risk 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.
Cardiac disorders Unexpected chest pain	3.3% 1/30 • Number of events 1 • 16 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."	0.00% 0/30 • 16 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."

Other adverse events

Measure	Positive Psychology + Motivational Interviewing n=30 participants at risk 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.	MI-based Health Educational Intervention n=30 participants at risk 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.
General disorders Unexpected dizziness	0.00% 0/30 • 16 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."	3.3% 1/30 • Number of events 1 • 16 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."
Cardiac disorders Unexpected chest pain	3.3% 1/30 • Number of events 1 • 16 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."	3.3% 1/30 • Number of events 1 • 16 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."
Cardiac disorders Unexpected shortness of breath and atrial fibrilation	3.3% 1/30 • Number of events 1 • 16 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."	0.00% 0/30 • 16 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."
General disorders Unexpected body numbness and shoulder pain	0.00% 0/30 • 16 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."	3.3% 1/30 • Number of events 1 • 16 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."
Injury, poisoning and procedural complications Foot injury	0.00% 0/30 • 16 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."	3.3% 1/30 • Number of events 1 • 16 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."
Endocrine disorders Unexpected hypoglycemia	6.7% 2/30 • Number of events 4 • 16 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."	0.00% 0/30 • 16 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."
General disorders Unexpected urethral stone	3.3% 1/30 • Number of events 1 • 16 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."	0.00% 0/30 • 16 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."
General disorders Unexpected abdominal pain	0.00% 0/30 • 16 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."	3.3% 1/30 • Number of events 1 • 16 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."

Additional Information

Dr. Jeff Huffman

Massachusetts General Hospital

Phone: 617-724-2910

Email: JHUFFMAN@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place