RecruitingNot ApplicableNCT05420051

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

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


Sponsor

Massachusetts General Hospital

Enrollment

280 participants

Start Date

Oct 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured wellness program can improve emotional well-being and happiness in people with Type 2 Diabetes who are not very physically active. Living with diabetes can be stressful, and this intervention combines physical activity with mental well-being strategies to improve quality of life. **You may be eligible if...** - You have been diagnosed with Type 2 Diabetes - You currently do less than 150 minutes of moderate-to-vigorous exercise per week (considered low activity) **You may NOT be eligible if...** - You have a cognitive impairment that prevents you from giving informed consent or participating fully - You have a medical condition likely to result in death within 12 months - You have a physical condition that prevents you from exercising safely - You have a severe mental health condition currently requiring intensive treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPositive 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.

BEHAVIORALMotivational 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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05420051


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