MObile Support Adapted to Individual Contexts

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: NCT06828549
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

MOSAIC intervention components include:

* Monthly coaching sessions (\~30 minutes each) - Persons with diabetes (PWD) will engage in goal setting and skill building relevant to their self-identified diet, exercise, and/or stress management goal

* Daily one-way and interactive text messages to support the PWD in meeting their goal and supporting medication adherence

* Weekly interactive text messages asking the PWD to reflect on goal progress followed by personalized feedback from their coach

* The option to invite an adult support person (SP). SPs may be invited to participate in monthly phone coaching and/or receive text messages (3 one-way texts per week and one interactive text per week) pertaining to supporting the PWD, per the MOSAIC intervention adaptive tailoring rules

PWD participants will be randomized in a parallel design to the MOSAIC adaptive mobile phone-delivered intervention or to print materials alone. The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects during the intervention (4 and 8 months) and post-intervention (12 months) and sustained effects (16 months). Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals) and missing data will be imputed.

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Status Verified: 2025-03
• Study Start: 2025-03-21
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 547

Inclusion Criteria

PERSONS WITH DIABETES:

• Speaks and reads in English
• 18-75 years old
• Diagnosed with type 2 diabetes
• Receiving outpatient care from a partnering clinic
• Community-dwelling (e.g., not in a nursing facility)
• Prescribed at least one daily diabetes medication
• Owns a mobile phone

SUPPORT PERSONS:

• Speaks and reads in English
• 18 years or older
• Owns a mobile phone

Exclusion Criteria

PERSONS WITH DIABETES:

• Unable to communicate by phone
• Currently pregnant
• Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
• Diagnosed with end-stage renal disease
• Receiving hospice services*
• Diagnosed with congestive heart failure
• Diagnosed with dementia
• Diagnosed with schizophrenia
• Demonstrated an inability to receive and respond to a text
• Does not take medication on his/her own/medication administered by someone else

SUPPORT PERSONS:

• Demonstrated inability to receive & respond to a text
• Unable to communicate by phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c During Intervention Period	Baseline and 4, 8, and 12 months post-baseline	Hemoglobin A1c assessed by mail-in A1c kits from BioQuintex and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management
Change in Hemoglobin A1c Sustained Post-intervention Effects	Baseline and 16 months post-baseline	Hemoglobin A1c assessed by mail-in A1c kits from BioQuintex and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management

Secondary Outcome Measures

Name	Time	Method
Change in Diabetes Distress During Intervention Period	Baseline and 4, 8, and 12 months post-baseline	Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse)
Change in Diabetes Distress Sustained Post-intervention Effect	Baseline and 16 months post-baseline	Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse)
Change in Psychosocial Well-being During Intervention Period	Baseline and 4, 8, and 12 months post-baseline	Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)
Change in Psychosocial Well-being Sustained Post-intervention Effect	Baseline 16 months post-baseline	Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)

Trial Locations

Locations (2)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States