MOSAIC Mobile Program for Type 2 Diabetes
(MOSAIC Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

Trial Summary

What is the purpose of this trial?

This behavioral clinical trial evaluates an adaptively tailored, mobile phone-delivered intervention (MOSAIC) designed to support adults managing their type 2 diabetes. Adaptive means the intervention can change over time. Tailored means the intervention may be different for different participants. The main questions the study will aim to answer are: 1. Does the diabetes education and support delivered via the MOSAIC adaptive mobile phone-delivered intervention improve outcomes more than diabetes education and support delivered via print materials alone? This aim compares the study arms on outcomes such as glycemic management (hemoglobin A1c), diabetes distress, and psychosocial well-being. This aim also compares the study arms on intervention targets (mediators) including diabetes self-efficacy and self-care behaviors. 2. For whom does the MOSAIC adaptive tailoring approach improve outcomes more than the print materials alone? This aim examines how well the tailoring rules used for the MOSAIC intervention worked for different participants on the outcomes examined in the first aim. Participants will enroll in a 16-month study with assessments every 4 months. Assessments include completion of an A1c test and a survey. For those assigned to MOSAIC, they will experience 12-months of mobile phone-delivered support with 3 opportunities for intervention tailoring.

Research Team

Eligibility Criteria

This trial is for adults with type 2 diabetes who are interested in managing their condition. Participants will be involved in a 16-month study, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am 18-75, have type 2 diabetes, take daily medication for it, and own a mobile phone.

My support person is an adult who speaks English and owns a mobile phone.

Exclusion Criteria

Support persons: Demonstrated inability to receive & respond to a text, unable to communicate by phone

I have diabetes but none of the listed conditions or limitations.

Treatment Details

Interventions

MOSAIC (Behavioural Intervention)

Trial OverviewThe trial tests an adaptive mobile phone-delivered intervention called MOSAIC against traditional print materials for diabetes education and support. It measures effectiveness by looking at blood sugar control, emotional well-being, self-confidence in managing diabetes, and self-care actions.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MOSAICExperimental Treatment2 Interventions

PWD participants will receive MOSAIC components (monthly phone coaching and text message support for goals and medication adherence) for 12 months. PWD participants will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. All SP participants invited by PWD participants assigned to MOSAIC will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. SPs may participate in monthly phone coaching and/or receive text message support tailored to the goal set by the linked PWD.

Group II: Print MaterialsPlacebo Group1 Intervention

PWD participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on health living with diabetes.