Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
226 participants
INTERVENTIONAL
2020-02-05
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
NCT06375460
Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
NCT03130699
Short Messaging Service for Optimizing Hemoglobin A1C Management in Low-Income Diabetics
NCT02049359
MyDiaText Text Messaging Intervention for Diabetes
NCT02927639
Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c
NCT03092882
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In the DIAMANTE Randomized Controlled Trial, we aim to examine the effect of a smartphone app that uses reinforcement learning to predict the most effective messages for increasing physical activity. We will recruit 276 low-income minority patients with depression and diabetes within he San Francisco Health Network. We will compare this intervention to static messages with health management content, and a control group that only receives a weekly mood message.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Static Messaging
We will send patients a total of seven messages per week (one per day) at 10.00 am. For the physical health management messages we use messages from established topics in the Diabetes Prevention Program(23) content with the emphasis on physical activity and stress management. The final message, on the seventh day will ask patients to rate their mood on a scale from 1 to 9. Physical activity (step-count/day) will be passively monitored via the app on their smartphone.
DIAMANTE Static
The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
Adaptive Messaging
Patients in the adaptive messaging arm will receive the daily messages of the static arm, and additionally receive daily messages within different categories of feedback and motivational messages that are chosen using a reinforcement learning (RL) algorithm. Physical activity (step-count/day) will be actively monitored via the app on their smartphone.
DIAMANTE Adaptive
In a three arm randomized controlled trial we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen by a reinforcement learning algorithm.
Control Condition
Control patients will only install the app on their phone and will not receive any feedback messages. They will receive one message a week, on a fixed day, asking them to assess their mood in the previous week on a scale of 1 to 9. The message will be sent daily at 10:00 am. Non-responders will receive reminders to submit their mood self-assessments in two hour intervals.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DIAMANTE Adaptive
In a three arm randomized controlled trial we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen by a reinforcement learning algorithm.
DIAMANTE Static
The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* PHQ-8 (Patient Health Questionnaire-8) \> 5
Exclusion Criteria
* pregnancy
* inability to exercise due to physical disability
* serious mental illness
* unable to read and write in English or Spanish
* plans to leave the country for extended periods of time during the trial
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Berkeley
OTHER
Agency for Healthcare Research and Quality (AHRQ)
FED
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Courtney Lyles, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Adrian Aguilera, PhD
Role: PRINCIPAL_INVESTIGATOR
UC Berkeley
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zuckerberg San Francisco General Hospital/University of California, San Francisco
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Aguilera A, Schueller SM, Leykin Y. Daily mood ratings via text message as a proxy for clinic based depression assessment. J Affect Disord. 2015 Apr 1;175:471-4. doi: 10.1016/j.jad.2015.01.033. Epub 2015 Jan 29.
Lyles CR, Ratanawongsa N, Bolen SD, Samal L. mHealth and Health Information Technology Tools for Diverse Patients with Diabetes. J Diabetes Res. 2017;2017:1704917. doi: 10.1155/2017/1704917. Epub 2017 Feb 23. No abstract available.
Nouri SS, Avila-Garcia P, Cemballi AG, Sarkar U, Aguilera A, Lyles CR. Assessing Mobile Phone Digital Literacy and Engagement in User-Centered Design in a Diverse, Safety-Net Population: Mixed Methods Study. JMIR Mhealth Uhealth. 2019 Aug 29;7(8):e14250. doi: 10.2196/14250.
Avila-Garcia P, Hernandez-Ramos R, Nouri SS, Cemballi A, Sarkar U, Lyles CR, Aguilera A. Engaging users in the design of an mHealth, text message-based intervention to increase physical activity at a safety-net health care system. JAMIA Open. 2019 Oct 11;2(4):489-497. doi: 10.1093/jamiaopen/ooz049. eCollection 2019 Dec.
Hernandez-Ramos R, Aguilera A, Garcia F, Miramontes-Gomez J, Pathak LE, Figueroa CA, Lyles CR. Conducting Internet-Based Visits for Onboarding Populations With Limited Digital Literacy to an mHealth Intervention: Development of a Patient-Centered Approach. JMIR Form Res. 2021 Apr 29;5(4):e25299. doi: 10.2196/25299.
Figueroa CA, Aguilera A, Chakraborty B, Modiri A, Aggarwal J, Deliu N, Sarkar U, Jay Williams J, Lyles CR. Adaptive learning algorithms to optimize mobile applications for behavioral health: guidelines for design decisions. J Am Med Inform Assoc. 2021 Jun 12;28(6):1225-1234. doi: 10.1093/jamia/ocab001.
Aguilera A, Figueroa CA, Hernandez-Ramos R, Sarkar U, Cemballi A, Gomez-Pathak L, Miramontes J, Yom-Tov E, Chakraborty B, Yan X, Xu J, Modiri A, Aggarwal J, Jay Williams J, Lyles CR. mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study. BMJ Open. 2020 Aug 20;10(8):e034723. doi: 10.1136/bmjopen-2019-034723.
Figueroa CA, Deliu N, Chakraborty B, Modiri A, Xu J, Aggarwal J, Jay Williams J, Lyles C, Aguilera A. Daily Motivational Text Messages to Promote Physical Activity in University Students: Results From a Microrandomized Trial. Ann Behav Med. 2022 Feb 11;56(2):212-218. doi: 10.1093/abm/kaab028.
Aguilera A, Arevalo Avalos M, Xu J, Chakraborty B, Figueroa C, Garcia F, Rosales K, Hernandez-Ramos R, Karr C, Williams J, Ochoa-Frongia L, Sarkar U, Yom-Tov E, Lyles C. Effectiveness of a Digital Health Intervention Leveraging Reinforcement Learning: Results From the Diabetes and Mental Health Adaptive Notification Tracking and Evaluation (DIAMANTE) Randomized Clinical Trial. J Med Internet Res. 2024 Oct 8;26:e60834. doi: 10.2196/60834.
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.