Summary

for people ages 18-75 (full criteria)
healthy people welcome
study started
estimated completion:
Courtney Lyles

Description

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.

Official Title

Improving Diabetes and Depression Self-management Via Adaptive Mobile Messaging

Details

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.

Keywords

Diabetes Depression Physical Activity Diabetes Mellitus Depressive Disorder DIAMANTE Static messaging Adaptive Messaging

Eligibility

You can join if…

Open to people ages 18-75

  • HbAc > 7
  • PHQ-9 > 9

You CAN'T join 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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03490253
Lead Scientist
Courtney Lyles
Study Type
Interventional
Last Updated