Diabetes and Depression Text Messaging Intervention

NCT03490253 | Completed DMC

• 1 other identifier: R01HS025429-02
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of the "Diabetes and Mental Health Adaptive Notification Tracking and Evaluation" trial (DIAMANTE) is to test a smartphone intervention that generates adaptive messaging, learning from daily patient data to personalize the timing and type of text-messages. We will compare the adaptive content to 1. a static messaging intervention with health management and educational messages and 2. a control condition that receives a weekly mood message. The primary outcomes for this aim will be improvements in physical activity at 6-month follow-up defined by daily step counts.

Conditions

Diabetes; Depression; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  Our primary outcome, change in daily step counts, will be passively collected by a mobile phone application during the time that patients remain in the intervention.

  6 months

Secondary Outcomes (2)

• Hemoglobin A1c

  6 months

• Patient Health Questionnaire-8 (PHQ-8)

  6 months

Study Arms (3)

Static Messaging

ACTIVE COMPARATOR

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.

Behavioral: DIAMANTE Static

Adaptive Messaging

EXPERIMENTAL

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.

Behavioral: DIAMANTE Adaptive

Control Condition

NO INTERVENTION

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.

Interventions

DIAMANTE Adaptive BEHAVIORAL

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.

Also known as: Adaptive Mobile Messaging

Adaptive Messaging

DIAMANTE Static BEHAVIORAL

The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.

Also known as: Static Mobile Messaging

Static Messaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c (Hemoglobin A1c) \> 7
• PHQ-8 (Patient Health Questionnaire-8) \> 5

You may not qualify if:

• high levels of physical activity (\>30 minutes of moderate to vigorous activity per day)
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Berkeley: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital/University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Publications (9)

• 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.

  PMID: 25679202 BACKGROUND

• 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.

  PMID: 28326330 BACKGROUND

• 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.

  PMID: 31469083 RESULT

• 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.

  PMID: 32025646 RESULT

• 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.

  PMID: 33872184 RESULT

• 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.

  PMID: 33657217 RESULT

• 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.

  PMID: 32819981 RESULT

• 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.

  PMID: 33871015 RESULT

• 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.

  PMID: 39378080 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Courtney Lyles, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Adrian Aguilera, PhD

  UC Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators and those completing the statistical analyses will not be aware of the true study assignments
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized, controlled, one-center superiority trial with three-arm groups and a primary endpoint of increase in daily steps during a 6 month intervention by a smartphone app. Randomization will be performed as block randomization with a 1:1:1 allocation. Patients will be automatically randomized into groups trough our secure server during on-boarding of the app. Patients need to be informed of the nature and frequency of the messages they will be receiving and discuss this with investigators during the course of the study. Therefore, investigators and patients will not be blinded. We used the SPIRIT checklist when writing our report.

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 6, 2018
• Study Start: February 5, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Within 1-3 years after the end of the trial.
• Access Criteria: Curated technical appendices, statistical code, and anonymized data will become freely available from the corresponding authors upon request.

Locations

US (1)