Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DREAM | Experimental | Participants will engage in twice weekly, interactive messaging sessions with DREAM, a computer-based messaging system designed to help people engage in more physical activity and improve overall well-being. In the first session of each week, participants will set a physical activity goal and learn a new positive psychology topic. They will review goals and topics from the prior week. In the second session, participants will be reminded of the goals set during the first messaging session earlier that week. The program will run for eight weeks. |
|
| Wait-list control | No Intervention | Participants in the wait-list control condition will engage in usual medical care for eight weeks, then will complete the DREAM program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DREAM | Behavioral | Participants will engage in twice weekly messaging sessions and will work towards a physical activity goal each week for a total of eight weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delivery of messaging sessions (feasibility) | Proportion of messaging sessions successfully initiated | Twice weekly over 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of the DREAM program | 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. | 8 weeks |
| Utility of messaging sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sedentary time (in mean minutes/day) | Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer. | Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only) |
| Change in self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher M Celano, M.D. | Contact | 617-726-6485 | ccelano@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher M Celano, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| 8 weeks |
| Change in overall physical activity (in steps/day) | 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. | Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only) |
| Change in moderate to vigorous physical activity (MVPA; in mean minutes/day) | MVPA (reported in mean minutes of MVPA/day) will be measured via an Actigraph accelerometer and recorded in mean minutes/day | Measured for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only) |
| Change in positive affect (Positive and Negative Affect Schedule [PANAS] positive affect items) | 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. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity. |
| Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in optimism (Life Orientation Test - Revised [LOT-R]) | Optimism will be measured using the Life Orientation Test - Revised (LOT-R), a frequently used 6-item instrument that assesses dispositional optimism. LOT-R scores range from 0-24, with higher scores indicating higher levels of optimism. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in depressive symptoms (depression subscale of the Hospital Anxiety and Depression Scale [HADS]) | Depressive symptoms will be measured using the 7-item depression subscale of the Hospital Anxiety and Depression Scale (HADS). The depression subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of depression. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale [HADS]) | Anxiety will be measured using the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of anxiety. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in exercise self-efficacy (Self-Efficacy for Exercise scale [SEE]) | Exercise self-efficacy will be measured via the Self-Efficacy for Exercise (SEE) scale. SEE scores range from 0-90, with higher scores indicating higher levels of self-efficacy for exercise. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in perceived social support (Multidimensional Scale of Perceived Social Support) | Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C]) | Locus of control will be measured using the 18-item Multidimensional Health Locus of Control scale [MHLC Form C]. Scores on this scale range from 6-36, with higher scores indicating greater internal health locus of control. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in positive affect during activity (Physical Activity Enjoyment Scale) | Positive affect during activity will be measured using the Physical Activity Enjoyment Scale. Physical Activity Enjoyment Scale scores range from 18-126, with higher scores indicating higher levels of enjoyment during activity. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score) | The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score) | The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| Change in adherence to a diabetes diet (General diet items of the Summary of Diabetes Self-Care Activities [SDSCA]) | Measured by the general diet items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate greater adherence. | Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group) |
| D004700 | Endocrine System Diseases |