Clinical trial NCT05420051: Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes
Official title: A Novel Psychological-behavioral Intervention to Promote Physical Activity in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks
timeFrame: Measured for 7 days at baseline and 16 weeks
Secondary outcomes:
measure: Change from Baseline Overall Activity at 16 weeks
timeFrame: Measured for 7 days at baseline and 16 weeks
measure: Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 16 weeks
timeFrame: Baseline, 16 weeks
Other outcomes:
measure: Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 8, 24, and 52 weeks
timeFrame: Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks
measure: Change from Baseline Overall Activity at 8, 24, and 52 weeks
timeFrame: Measured for 7 days at baseline, 8 weeks, 24, weeks, and 52 weeks
measure: Change from Baseline in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) at 8, 24, and 52 weeks
timeFrame: Baseline, 8 weeks, 24 weeks, 52 weeks
measure: Change in optimism (Life Orientation Test - Revised [LOT-R])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in depressive symptoms (Patient Health Questionnaire [PHQ-9])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in anxiety (Hospital Anxiety and Depression Scale - anxiety subscale [HADS-A])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in perceived social support (Multidimensional Scale of Perceived Social Support [MSPSS])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in exercise-related self-efficacy (Self-efficacy for Exercise Scale [SEE])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in physical function (PROMIS 20-item Physical Function Short Form [PF-20])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in adherence to a diabetes diet (General diet items of the Summary of Diabetes Self-Care Activities [SDSCA])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in adherence to fruits, vegetables, and low fat foods (Specific diet items of the Summary of Diabetes Self-Care Activities [SDSCA])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in exercise (Exercise items of the Summary of Diabetes Self-Care Activities [SDSCA])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in frequency of blood glucose testing (Blood glucose testing items of the Summary of Diabetes Self-Care Activities [SDSCA])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in foot care (Foot care items of the Summary of Diabetes Self-Care Activities [SDSCA])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in self-reported MVPA (International Physical Activity Questionnaire [IPAQ])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in self-reported sedentary time (International Physical Activity Questionnaire [IPAQ])
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in weight (kilograms)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in body mass index (kilograms per square meter)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in blood pressure (millimeters of mercury)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in hemoglobin A1C (%)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in low density lipoprotein (LDL) and high density lipoprotein (HDL) cholesterol (milligrams per deciliter)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
measure: Change in triglycerides (milligrams per deciliter)
timeFrame: Baseline, 8 weeks, 16 weeks, 24 weeks, 52 weeks
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: