NCT07225283

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
7mo left

Started Sep 2026

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

November 4, 2025

Last Update Submit

May 15, 2026

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Delivery of messaging sessions (feasibility)

    Proportion of messaging sessions successfully initiated

    Twice weekly over 8 weeks

Secondary Outcomes (5)

  • Utility of the DREAM program

    8 weeks

  • Utility of messaging sessions

    8 weeks

  • 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)

  • 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)

  • 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)

Other Outcomes (12)

  • Change in sedentary time (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 self-reported physical activity (International Physical Activity Questionnaire [IPAQ]; in metabolic equivalent-minutes/week)

    Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

  • Change in optimism (Life Orientation Test - Revised [LOT-R])

    Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

  • +9 more other outcomes

Study Arms (2)

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.

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.

Interventions

DREAMBEHAVIORAL

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

DREAM

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Christopher M Celano, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher M Celano, M.D.

CONTACT

617-726-6485ccelano@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director, Cardiac Psychiatry Research Program

Study Record Dates

First Submitted

November 4, 2025

First Posted

November 6, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)