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

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.

ClinicalTrials.gov IDNCT05420051

PhaseNA

Enrollment280

SponsorMassachusetts General Hospital

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Diabetes Mellitus, Type 2

About this study

Interventions

Behavioral: Positive Psychology + Motivational Interviewing — 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.
Behavioral: Motivational Interviewing — 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.

Primary outcomes

Change from Baseline Moderate to Vigorous Physical Activity (MVPA) at 16 weeks (Measured for 7 days at baseline and 16 weeks)

Eligibility information

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

Study locations

Massachusetts General Hospital, Boston, Massachusetts 02114 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.