MObile Support Adapted to Individual Contexts

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06828549
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MOSAIC — BEHAVIORAL
    All MOSAIC PWD participants receive monthly phone coaching following a semi-structured protocol plus daily automated text message support. MOSAIC uses the mobile phone-delivered structure and functionality developed for FAMS (NCT04347291). Tailoring rules novel to MOSAIC determine phone coaching protocol content, text message content, and the involvement of a SP. Semi-structured protocols used in prior studies (and in the case of NCT04334109 adapted for mobile phone-delivery) are employed. Per tailoring rules, enrolled SPs may be invited to participate in monthly coaching calls with the PWD and/or receive text messages about supporting the PWD. The study will not assess outcomes or effects among SPs.
  • Print Materials — BEHAVIORAL
    Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters

Study Details

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.

Key Dates

Start date
Mar 21, 2025
Status verified
Mar 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
547 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: MOSAIC
    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.
  • Placebo Comparator: Print Materials
    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.

Primary Outcome Measure

Change in Hemoglobin A1c During Intervention Period [ Time Frame: Baseline and 4, 8, and 12 months post-baseline ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Vanderbilt University Medical CenterNashvilleTennessee37203-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Alabama at Birmingham· Birmingham, ALVanderbilt University Medical Center· Nashville, TN

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