[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07225283":3,"trial-entities:NCT07225283":99,"trial-summary:NCT07225283":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":58,"minimum_age":59,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":73,"locations":77,"central_contacts":92,"overall_officials":94,"references":97,"see_also_links":98},"NCT07225283","2025P002706","Developing Resiliency and Exercise Using AI-based Messaging","Developing Resiliency and Exercise Using AI-based Messaging: The DREAM Pilot Study","NOT_YET_RECRUITING","2027-03-31","2026-05","2026-05-18","2026-09-01","Massachusetts General Hospital","OTHER",false,"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.","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.",[19],"Diabetes Mellitus Type 2",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},20,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[31],[35],{"measure":36,"description":37,"timeFrame":38},"Delivery of messaging sessions (feasibility)","Proportion of messaging sessions successfully initiated","Twice weekly over 8 weeks",[40,44,47,51,54],{"measure":41,"description":42,"timeFrame":43},"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",{"measure":45,"description":46,"timeFrame":43},"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.",{"measure":48,"description":49,"timeFrame":50},"Change in overall physical activity (in steps\u002Fday)","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)",{"measure":52,"description":53,"timeFrame":50},"Change in moderate to vigorous physical activity (MVPA; in mean minutes\u002Fday)","MVPA (reported in mean minutes of MVPA\u002Fday) will be measured via an Actigraph accelerometer and recorded in mean minutes\u002Fday",{"measure":55,"description":56,"timeFrame":57},"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)","ALL",null,{"inclusion":61,"exclusion":65,"raw_text":72},[62,63,64],"Type 2 diabetes diagnosis (A1c ≥6.5%, fasting glucose ≥126 mg\u002FdL)","Suboptimal physical activity (score \\\u003C 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",[66,67,68,69,70,71],"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\u002Fwrite fluently in English","Use of non-basal insulin","Inclusion Criteria:\n\n* Type 2 diabetes diagnosis (A1c ≥6.5%, fasting glucose ≥126 mg\u002FdL)\n* Suboptimal physical activity (score \\\u003C 5 on the Medical Outcomes Study Specific Adherence Scale physical activity item)\n* Access to a smartphone (i.e., Android or iOS) or computer with access to the internet and an internet browser\n\nExclusion Criteria:\n\n* An unrelated condition limiting physical activity\n* Participation in any other programs focused on physical activity or well-being\n* A cognitive disturbance precluding participation or informed consent\n* Current pregnancy or plan to become pregnant in the next 16 weeks\n* Inability to speak\u002Fwrite fluently in English\n* Use of non-basal insulin",[74,75,76],"CHILD","ADULT","OLDER_ADULT",[78],{"facility":13,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Boston","Massachusetts","02114","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Christopher M Celano, M.D.","CONTACT","617-726-6485","ccelano@mgh.harvard.edu",{"lat":90,"lon":91},42.35843,-71.05977,[93],{"name":85,"role":86,"phone":87,"email":88},[95],{"name":85,"affiliation":13,"role":96},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is a randomized, controlled pilot study with a planned enrollment of 20 participants.","completed","DREAM Program for Type 2 Diabetes","This study is testing a program called DREAM, which uses messages to help adults with type 2 diabetes increase their physical activity and overall well-being. You might be able to join if you have type 2 diabetes (with an A1c of 6.5% or higher, or fasting glucose of 126 mg\u002FdL or higher), don't get enough physical activity, and have a smartphone or computer with internet access. The main goal is to see if the messaging sessions can be successfully delivered and if people find them helpful. This study is currently recruiting participants.","The primary endpoint for feasibility is measured twice weekly over 8 weeks.",92,"Participants will engage in twice-weekly messaging sessions and work towards a physical activity goal each week for a total of eight weeks.","Not stated in the trial record.",[31],"v2"]