NCT05420051 Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes
| NCT ID | NCT05420051 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2022-10-12 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2022-10-12 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05420051 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05420051 currently recruiting?
Yes, NCT05420051 is actively recruiting participants. Contact the research team at jhuffman@partners.org for enrollment information.
Where is the NCT05420051 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05420051 clinical trial?
NCT05420051 is sponsored by Massachusetts General Hospital. The trial plans to enroll 280 participants.
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