ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes and Depression Text Messaging Intervention (DIAMANTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03490253
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
Courtney Lyles, University of California, San Francisco

Brief Summary:

The first goal of the randomized trial will be to study the influence of personalized text messaging on both glycemic control and depressive symptoms. The primary outcomes for this aim will be improvements in physical activity. The secondary outcomes include diabetes and depressive symptoms at the 6-month follow-up, as well as mood and quality of life.

The secondary goal of the trial is to evaluate the influence of nurse phone outreach on glycemic control and depressive symptoms for participants who are non-responsive to the text messaging approaches used in this study. In particular, a sequential multiple assignment randomized trial (SMART) design will use responsiveness data from participants during the course of the study to implement a second randomization step for nurse phone outreach.We will examine the same primary outcome and secondary health behavior outcomes among this sub-group.


Condition or disease Intervention/treatment Phase
Diabetes Depression Physical Activity Behavioral: DIAMANTE Behavioral: Static messaging Not Applicable

Detailed Description:

The DIAMANTE intervention will develop motivational messages that will come from various attitudes, norms, and self-efficacy categories that might differentially motivate patients to act (e.g., informational: health, physical appearance, social: family, peers, and self-confidence). User center testing will also produce feedback from clinicians on the study platform and adoption of a new technology in busy primary care settings. The findings of this user centered testing with participants and clinicians will inform the development of combined diabetes and depression text messaging intervention that will be embedded into existing primary care practice.

Following the completion of user centered design, we will recruit 350 adults from primary care clinics at the San Francisco Health Network. The design will be randomized clinical trial comparing the effectiveness of static messaging vs adaptive messaging intervention on depression and diabetes outcomes. At the1-month point of the intervention, the non-responsive individuals in both treatment arms will be randomized again, with half of non-respondents to receive the intensified nurse phone outreach component of the study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: First randomization into adaptive vs. static text messaging support for physical activity; Second randomization will re-randomize those who have dropped out into receiving vs. not receiving phone outreach
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants in the static and adaptive messaging arms receive different total number of messages per week and therefore might be aware of their assignment. The investigators and those completing the statistical analyses will not be aware of the true study assignments
Primary Purpose: Supportive Care
Official Title: Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Static Messaging
Participants in this arm will receive educational and motivational messages about physical activity, depression, and diabetes, according to a prespecified content order.
Behavioral: Static messaging
Participants in the control arm will receive educational and motivational content on a regular basis.

Experimental: Adaptive Messaging
Participants in this arm will receive the DIAMANTE intervention in which a machine learning algorithm will be adapting the motivational content they receive to try to optimize physical activity based on the message type.
Behavioral: DIAMANTE
By designing and testing an adaptive mobile health intervention within a safety net setting, we will increase the likelihood that the vulnerable populations most impacted by diabetes and depression will actually receive the support they need to make significant lifestyle changes, thereby improving their overall health.
Other Name: Adaptive Mobile Messaging




Primary Outcome Measures :
  1. Physical activity [ Time Frame: 6 months ]
    Total change in daily steps assessed via smartphone pedometer application


Secondary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 months ]
    Diabetes control measure assessed via blood work for diabetes patients, usually every 3 months during regular clinical visits. An A1c>7% is considered high.

  2. Patient Health Questionnaire-9 [ Time Frame: 6 months ]
    Depressive symptoms assessed via 9-item survey measure, with a score of 0-27 (10 or higher indicating moderate or severe symptoms)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HbAc > 7
  • PHQ-9 > 9

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490253


Contacts
Contact: Courtney Lyles, PhD (415) 206-6483 courtney.lyles@ucsf.edu
Contact: Anupama Cemballi, MA (415) 206-7878 anupama.cemballi@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
University of California, Berkeley
Investigators
Principal Investigator: Courtney Lyles, PhD University of California, San Francisco
Principal Investigator: Adrian Aguilera, PhD UC Berkeley

Publications:
Responsible Party: Courtney Lyles, Assistant Professor of Medicine, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03490253     History of Changes
Other Study ID Numbers: R01HS025429-02 ( U.S. AHRQ Grant/Contract )
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders