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

Mass General Brigham

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Motivational Interviewing; Behavioral: Positive Psychology + Motivational Interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT05420051

2022P000780

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. 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.
3. 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Positive Psychology + Motivational Interviewing

Experimental group

Description:

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).

Treatment:

Behavioral: Positive Psychology + Motivational Interviewing

Motivational Interviewing

Active Comparator group

Description:

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).

Treatment:

Behavioral: Motivational Interviewing