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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03490253
Study type Interventional
Source University of California, San Francisco
Contact Courtney Lyles, PhD
Phone (415) 206-6483
Email courtney.lyles@ucsf.edu
Status Not yet recruiting
Phase N/A
Start date March 2019
Completion date September 2020

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