Improving emotional well-being and happiness for outpatients with diabetes
A Novel Psychological-behavioral Intervention to Promote Physical Activity in Type 2 Diabetes
This study is testing if an 8-week program that combines positive psychology and motivational support, along with regular text messages, can help people with type 2 diabetes feel happier and more active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05420051 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of an 8-week positive psychology and motivational interviewing intervention, supplemented by twice-weekly text messages over 16 weeks, for individuals with type 2 diabetes who have low physical activity levels. Participants will be randomly assigned to either the intervention group or a control group receiving motivational interviewing alone. The study aims to evaluate the impact of this intervention on physical activity, psychological well-being, diabetes self-care, and overall health outcomes. Participants will wear accelerometers to monitor their physical activity and complete various psychological assessments throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with type 2 diabetes who engage in less than 150 minutes of moderate to vigorous physical activity per week.
Not a fit: Patients with cognitive deficits, severe depression, or other medical conditions that prevent participation in physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance emotional well-being and increase physical activity among patients with type 2 diabetes, leading to improved health outcomes.
How similar studies have performed: Other studies have shown promising results using motivational interviewing and positive psychology approaches, suggesting potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Jeff C Huffman, M.D.
- Email: jhuffman@partners.org
- Phone: 617-724-2910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.