DREAM Program for Type 2 Diabetes

(DREAM Trial)

Overseen By Christopher M Celano, M.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Non-basal insulin

Disqualifiers: Pregnancy, Cognitive disturbance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program called DREAM can help people with type 2 diabetes become more active and improve overall well-being. Participants will use a messaging system twice a week to set activity goals and learn positive thinking techniques over an eight-week period. The program suits individuals with type 2 diabetes who are not very active and have access to a smartphone or computer. As an unphased trial, it offers a unique opportunity to explore new methods for enhancing health and well-being.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot use non-basal insulin.

What prior data suggests that the DREAM program is safe for adults with type 2 diabetes?

Research has shown that the DREAM program, which includes twice-weekly interactive messaging sessions to encourage physical activity and well-being, is easy for participants to handle. Early studies have examined the practicality and acceptability of these sessions, and so far, no serious side effects have been reported. The program aims to help people with type 2 diabetes set and reach exercise goals, which is generally safe and beneficial for their health. Since this program doesn't involve medication, the risk of side effects remains low. Joining this program should be a safe choice for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The DREAM program is unique because it uses interactive, computer-based messaging to encourage physical activity and boost well-being among people with Type 2 Diabetes. Unlike traditional treatments that primarily focus on medication and diet management, DREAM emphasizes setting and reviewing personal exercise goals while integrating positive psychology principles. Researchers are excited about this approach because it has the potential to empower patients to take an active role in managing their condition through regular engagement and personal motivation, possibly leading to improved health outcomes.

What evidence suggests that the DREAM program is effective for type 2 diabetes?

The DREAM program, available to participants in this trial, uses interactive messages to enhance physical activity and well-being and shows promise for individuals with type 2 diabetes. Research has indicated that similar programs have improved blood sugar levels and helped manage weight in past participants. Early results suggest that setting exercise goals and focusing on positive thinking can lead to better health. Although data collection for the DREAM program is ongoing, studies on similar programs are encouraging. ^{1 4 6 7 8}

Who Is on the Research Team?

Christopher M Celano, M.D.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who are interested in a program designed to increase physical activity and improve well-being. The details of eligibility criteria were not provided, so it's unclear who exactly can or cannot participate.

Inclusion Criteria

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

I have been diagnosed with Type 2 diabetes.

Exclusion Criteria

Participation in any other programs focused on physical activity or well-being

Current pregnancy or plan to become pregnant in the next 16 weeks

I have a health issue that restricts my physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the DREAM program, an 8-week message-based intervention to promote physical activity and well-being

8 weeks

Twice weekly messaging sessions

Follow-up

Participants are monitored for changes in physical activity, psychological, and health-related outcomes

8 weeks

Measured at baseline, 8 weeks, and 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DREAM

Trial Overview The DREAM program is being tested in this study. It's an 8-week intervention that uses AI-based messaging to encourage exercise and enhance overall health among people with type 2 diabetes.

How Is the Trial Designed?

Group I: DREAM Experimental Treatment 1 Intervention

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.

Group II: Wait-list control Active Control 1 Intervention

Participants in the wait-list control condition will engage in usual medical care for eight weeks, then will complete the DREAM program.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3933368/

Protocol for the DREAM Project (Diabetes Research ... Primary and secondary outcomes include clinical and behavioral measures, such as HbA1c and weight change, access to and utilization of care ( ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3711-y

The DREAM Initiative: study protocol for a randomized ... - Trials This study will be the first to test the efficacy of an integrated EHR–CHW intervention within an underserved, minority population and in a practical setting.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6868710/

The DREAM Initiative: study protocol for a randomized ... Results of the Indian Diabetes Prevention Program (DPP) and interventions conducted among South Asian immigrants in high-income countries have shown that modest ...

4. healio.com healio.com/news/endocrinology/20120325/dream-study-shows-effective-chemoprevention-of-diabetes

DREAM: Study shows effective chemoprevention of diabetes The results of the DREAM trial were recently reported. These results were remarkable for multiple reasons and offer substantial hope for ...

5. ijic.org ijic.org/articles/6025/files/submission/proof/6025-1-25545-1-10-20220512.pdf

Effectiveness of Integrated Diabetes Care Interventions ... Introduction: Evidence that integrated diabetes care interventions can substantially improve clinical outcomes is mixed.

6. diabetesjournals.org diabetesjournals.org/care/article/30/2/418/28326/Clinical-Implications-of-the-DREAM-Study

Clinical Implications of the DREAM Study | Diabetes Care In the DREAM study, rosiglitazone increased the likelihood of regression to normoglycemia by ∼70–80% suggesting that the drug was treating ...

7. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-2026-405bb

DREAM Program for Type 2 Diabetes · Info for Participants The DREAM medical study, being run by Massachusetts General Hospital, needs participants to evaluate whether DREAM will have tolerable side effects ...

8. link.springer.com link.springer.com/article/10.1007/s13300-025-01761-4

Type 2 Diabetes Mellitus Remission, Dream or Reality? A ... Empagliflozin reduced mortality and hospitalization for heart failure across the spectrum of cardiovascular risk in the EMPA-REG OUTCOME trial.