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NCT Number: NCT07225283

Developing Resiliency and Exercise Using AI-based Messaging

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location contact

Christopher M Celano, M.D.

CONTACT

[email protected]

617-726-6485

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DREAM

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.

Primary outcomes

  1. Delivery of messaging sessions (feasibility)

    Time frame: Twice weekly over 8 weeks

    Proportion of messaging sessions successfully initiated

Secondary outcomes

  1. Utility of the DREAM program

    Time frame: 8 weeks

    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.

  2. Utility of messaging sessions

    Time frame: 8 weeks

    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.

  3. 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)

    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.

  4. 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)

    MVPA (reported in mean minutes of MVPA/day) will be measured via an Actigraph accelerometer and recorded in mean minutes/day

  5. 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)

    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.

Other outcomes

  1. Change in sedentary time (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)

    Sedentary time (mean minutes/day) will be measured via Actigraph accelerometer.

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

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

    This will be measured via the International Physical Activity Questionnaire (IPAQ) as a secondary measure of physical activity.

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

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

    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.

  4. Change in depressive symptoms (depression subscale of the Hospital Anxiety and Depression Scale [HADS])

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

    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.

  5. Change in anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale [HADS])

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

    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.

  6. Change in exercise self-efficacy (Self-Efficacy for Exercise scale [SEE])

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

    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.

  7. Change in perceived social support (Multidimensional Scale of Perceived Social Support)

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

    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.

  8. Change in locus of control (Form C of the Multidimensional Health Locus of Control scale [MHLC Form C])

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

    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.

  9. Change in positive affect during activity (Physical Activity Enjoyment Scale)

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

    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.

  10. Change in physical health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] physical component score)

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

    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.

  11. Change in mental health-related quality of life (Medical Outcomes Study Short Form-12 [SF-12] mental component score)

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

    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.

  12. Change in adherence to a diabetes diet (General diet items of the Summary of Diabetes Self-Care Activities [SDSCA])

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher M Celano, M.D.

CONTACT

[email protected]

617-726-6485

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: DREAM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 6, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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