Diabetes Mellitus Type 2
Conditions
Brief summary
This is a randomized, controlled pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the DREAM program, an 8-week message-based intervention to promote physical activity and well-being in adults with type 2 diabetes.
Detailed description
This is a randomized, controlled pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the DREAM program. DREAM is an 8-week message-based program to promote physical activity and well-being in adults with type 2 diabetes. In DREAM, participants will complete twice weekly messaging sessions, in which they will set weekly physical activity goals and perform activities to enhance well-being. The primary outcome is feasibility (measured by number of messaging sessions successfully transmitted) and acceptability (measured by 0-10 utility ratings). Secondary outcomes include preliminary impact on physical activity and psychological and health-related outcomes.
Interventions
BEHAVIORALDREAM
Participants will engage in twice weekly messaging sessions and will work towards a physical activity goal each week for a total of eight weeks.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes diagnosis (A1c ≥6.5%, fasting glucose ≥126 mg/dL) * Suboptimal physical activity (score \< 5 on the Medical Outcomes Study Specific Adherence Scale physical activity item) * Access to a smartphone (i.e., Android or iOS) or computer with access to the internet and an internet browser
Exclusion criteria
* An unrelated condition limiting physical activity * Participation in any other programs focused on physical activity or well-being * A cognitive disturbance precluding participation or informed consent * Current pregnancy or plan to become pregnant in the next 16 weeks * Inability to speak/write fluently in English * Use of non-basal insulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery of messaging sessions (feasibility) | Twice weekly over 8 weeks | Proportion of messaging sessions successfully initiated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Utility of the DREAM program | 8 weeks | Participants will rate the utility of the DREAM program on an 11-point Likert scale (0-10), with 0 being not at all helpful and 10 being very helpful. |
| Utility of messaging sessions | 8 weeks | Participants will rate the utility of the messaging sessions, measured on an 11-point Likert scale (0-10), with 0 being not at all helpful and 10 being very helpful. |
| Change in overall physical activity (in steps/day) | Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only) | Physical activity (steps) will be measured via an Actigraph accelerometer. We will use established accelerometer protocols to measure the mean number of steps taken per day at each time point. |
| Change in moderate to vigorous physical activity (MVPA; in mean minutes/day) | Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only) | MVPA (reported in mean minutes of MVPA/day) will be measured via an Actigraph accelerometer and recorded in mean minutes/day |
| Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) | Positive affect (our main psychological outcome given its links to health outcomes and sensitivity to change) will be assessed via the Positive and Negative Affect Schedule (PANAS) positive affect items. PANAS scores range from 10-50, with higher scores indicating higher levels of positive affect. |
Countries
United States
Contacts
CONTACTChristopher M Celano, M.D.
PRINCIPAL_INVESTIGATORChristopher M Celano, M.D.
Massachusetts General Hospital
Outcome results
None listed