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Not yet recruiting NCT07225283

Developing Resiliency and Exercise Using AI-based Messaging

No phase Interventional Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DREAM.
Who it may be relevant to
Registry conditions: Diabetes Mellitus Type 2. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Developing Resiliency and Exercise Using AI-based Messaging: The DREAM Pilot Study

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Delivery of messaging sessions (feasibility) [Time frame: Twice weekly over 8 weeks]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07225283 · 2025P002706

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗