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Developing Resiliency and Exercise Using AI-based Messaging

NCT ID: NCT07225283

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DREAM

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 Type EXPERIMENTAL

DREAM

Intervention Type 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.

Wait-list control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DREAM

Participants will engage in twice weekly messaging sessions and will work towards a physical activity goal each week for a total of eight weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christopher Celano

Associate Director, Cardiac Psychiatry Research Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher M Celano, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Christopher M Celano, M.D.

Role: CONTACT

Phone: 617-726-6485

Email: [email protected]

Facility Contacts

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Christopher M Celano, M.D.

Role: primary

Other Identifiers

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2025P002706

Identifier Type: -

Identifier Source: org_study_id