Developing Resiliency and Exercise Using AI-based Messaging (DREAM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Behavioral: DREAM

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher M Celano, M.D.; Phone Number: 617-726-6485; Email: ccelano@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Christopher M Celano, M.D.; Phone Number: 617-726-6485; Email: ccelano@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery of messaging sessions (feasibility)	Proportion of messaging sessions successfully initiated	Twice weekly over 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
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.	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.	8 weeks
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 for 7 days at baseline (both groups), 8-weeks (both groups), and 16 weeks (wait-list control group only)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sedentary time (in mean minutes/day)	Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.	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)	This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in optimism (Life Orientation Test - Revised [LOT-R])	Optimism will be measured using the Life Orientation Test - Revised (LOT-R), a frequently used 6-item instrument that assesses dispositional optimism. LOT-R scores range from 0-24, with higher scores indicating higher levels of optimism.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale [HADS])	Anxiety will be measured using the 7-item anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of anxiety.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in exercise self-efficacy (Self-Efficacy for Exercise scale [SEE])	Exercise self-efficacy will be measured via the Self-Efficacy for Exercise (SEE) scale. SEE scores range from 0-90, with higher scores indicating higher levels of self-efficacy for exercise.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in perceived social support (Multidimensional Scale of Perceived Social Support)	Perceived social support will be measured by the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS scores range from 1-7, with higher scores indicating higher levels of perceived social support.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in positive affect during activity (Physical Activity Enjoyment Scale)	Positive affect during activity will be measured using the Physical Activity Enjoyment Scale. Physical Activity Enjoyment Scale scores range from 18-126, with higher scores indicating higher levels of enjoyment during activity.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in depressive symptoms (depression subscale of the Hospital Anxiety and Depression Scale [HADS])	Depressive symptoms will be measured using the 7-item depression subscale of the Hospital Anxiety and Depression Scale (HADS). The depression subscale of the HADS ranges from 0-21, with higher scores indicating higher levels of depression.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])	Locus of control will be measured using the 18-item Multidimensional Health Locus of Control scale [MHLC Form C]. Scores on this scale range from 6-36, with higher scores indicating greater internal health locus of control.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)	The SF-12 physical component score will be used to assess physical health-related quality of life (Range: 0-100). Higher scores indicate higher levels of physical health-related quality of life.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)	The SF-12 mental component score will be used to assess mental health-related quality of life (Range: 0-100). Higher scores indicate higher levels of mental health-related quality of life.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)
Change in adherence to a diabetes diet (General diet items of the Summary of Diabetes Self-Care Activities [SDSCA])	Measured by the general diet items of the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate greater adherence.	Baseline (both groups), 8 weeks (both groups), 16 weeks (wait-list control group)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Christopher M Celano, M.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 4, 2025
• First Submitted That Met QC Criteria: November 4, 2025
• First Posted (Actual): November 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2025P002706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No