Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes

Study Overview
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Brief Summary
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The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity.

Detailed Description
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The investigators are proposing a study that will focus on testing the efficacy of a PP-MI intervention, with additional twice text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks) in individuals with type 2 diabetes. The investigators will enroll 280 type 2 diabetes patients, who will take part in either an 8-week intervention (with 16 weeks of supplemental text messages) or an attention-matched, MI-alone condition. In this project, the investigators hope to do the following: Examine the efficacy of an 8-week, phone-delivered PP-MI intervention for individuals with type 2 diabetes on physical activity-related outcomes, as compared to the MI-alone condition. Assess PP-MI's impact on psychological measures (e.g., positive affect [key secondary outcome]), diabetes self-care, function, glycemic control, and cardiometabolic risk, compared to MI alone. Examine causal mediation of PP-MI's effects on MVPA at 16 weeks by positive affect (primary hypothesized mediator) and other psychological/cognitive variables across our theoretical model. Participants will be adult outpatients with type 2 diabetes. They will attend an in-person visit to provide informed consent and complete baseline outcome measures, then will wear an accelerometer to monitor their physical activity for one week to obtain information about baseline activity levels. Upon confirmation of low moderate to vigorous physical activity, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention. Participants in both groups will be provided a treatment manual, an activity tracker, and other treatment materials. The intervention will be introduced, and the first exercise will be assigned. Participants will complete eight weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment. Participants will receive twice weekly text messages throughout the intervention (Weeks 1-8) and initial follow-up period (Weeks 9-16). In the PP-MI condition, these messages will focus on the PP activity and physical activity, while those in the MI-alone condition will focus on physical activity and other health behaviors. During Weeks 9-16, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and physical activity, while those in the MI-alone condition will receive fixed text messages related to engagement in health behaviors. At Weeks 8, 16, 24, and 52, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. During these study visits, participants will complete outcome assessments and have a blood sample taken.

Official Title
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A Novel Psychological-behavioral Intervention to Promote Physical Activity in Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Positive Psychology + Motivational Interviewing
* Behavioral: Motivational Interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Type 2 Diabetes Low physical activity (<150 minutes/week of moderate to vigorous physical activity) Exclusion Criteria: Cognitive deficits impeding a participant's ability to provide informed consent or participate Medical conditions likely to lead to death within 6 months. Pre-existing coronary artery disease Moderate-severe depression (Patient Health Questionnaire-9 [PHQ-9] score ≥15) Use of non-basal insulin Inability to participate in physical activity due to another medical condition Inability to receive text messages Inability to read, write, or speak in English Current participation in another intervention or program that has been designed to promote well-being or physical activity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Psychology + Motivational Interviewing<br>Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16). | Behavioral: Positive Psychology + Motivational Interviewing<br>* The 8-week PP-MI intervention focuses on enhancing well-being (through PP) and increasing physical activity (through MI). Each week, participants will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to improve physical activity levels, resolve ambivalence to behavior change, set realistic physical activity goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 16 weeks) to encourage completion of PP activities and engagement in physical activity.<br>|
| Active Comparator: Motivational Interviewing<br>Each week, participants in the MI-alone group will complete an activity related to a health behavior (e.g., thinking about the pros and cons of changing the behavior), then complete a phone session with a study trainer. During the phone session, the trainer will (a) review the prior week's topic, (b) discuss techniques for improving adherence to health behaviors (e.g. tracking activity), and (c) problem-solve barriers and encourage the use of resources. Participants also will receive supplemental text messages throughout the 8 weeks of the intervention and during the initial follow-up period (Week 9-16). | Behavioral: Motivational Interviewing<br>* The 8-week MI-alone intervention focuses on providing education and enhancing motivation to engage in health behaviors (through MI). Each week, participants will complete an activity related to a health behavior (e.g., consider the pros and cons of behavior change, set a health behavior goal), then complete a phone session with a study trainer. This program will focus on assisting participants to improve health behavior adherence (including physical activity), resolve ambivalence to behavior change, set realistic health behavior goals, problem-solve barriers, and identify resources to complete behavior change. Additional time in MI-alone phone sessions will be spent on review of core MI skills, problem-solving of barriers, and discussion of resources. Finally, participants will receive twice weekly text messages (for 16 weeks) to encourage engagement in health behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks | MVPA will be measured via an accelerometer and recorded in mean minutes/day. | Measured for 7 days at baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Overall Activity at 16 weeks | Overall activity will be measured via an accelerometer and recorded in mean steps/day. | Measured for 7 days at baseline and 16 weeks | 
| Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 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 HF, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect. | Baseline, 16 weeks |