Diabetes Mellitus Type 2DREAMNCT07225283
Developing Resiliency and Exercise Using AI-based Messaging
A study testing DREAM in people with Diabetes Mellitus Type 2, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- DREAM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Christopher M Celano, M.D., 617-726-6485, ccelano@mgh.harvard.edu
About this study
Official title: Developing Resiliency and Exercise Using AI-based Messaging: The DREAM Pilot Study
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- DREAM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DREAMBehavioural
Participants will engage in twice weekly messaging sessions and will work towards a physical activity goal each week for a total of eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DREAM |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of messaging sessions (feasibility)
Proportion of messaging sessions successfully initiated
Measured: Twice weekly over 8 weeks
Secondary outcomes (5)
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.
Measured: 8 weeks
Utility of messaging sessions
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.
Measured: 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: 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: 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.
Measured: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Celano, Massachusetts General Hospital
- Investigators
- Christopher M Celano, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225283
- Sponsor's protocol ID
- 2025P002706
- Acronym
- DREAM
- Status last verified
- May 2026
- First submitted
- 4 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Resiliency and Exercise Using AI-based Messaging: The DREAM Pilot Study
- ClinicalTrials.gov ID
- NCT07225283
- Acronym / sponsor ID
- DREAM / 2025P002706
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DREAM | Experimental | Behavioral: DREAMParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DREAMParticipants will engage in twice weekly messaging sessions and will work towards a physical activity goal each week for a total of eight weeks. | Behavioural | DREAM |
Primary outcome
Delivery of messaging sessions (feasibility)
Time frame: Twice weekly over 8 weeks
Proportion of messaging sessions successfully initiated
5 secondary outcomes
Utility of the DREAM program
Time frame: 8 weeks
Utility of messaging sessions
Time frame: 8 weeks
Change in overall physical activity (in steps/day)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher M Celano, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DREAM in people with Diabetes Mellitus Type 2, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher M Celano, M.D. (617-726-6485, ccelano@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of messaging sessions (feasibility) (time frame: Twice weekly over 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.