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NCT Number: NCT06828549

MObile Support Adapted to Individual Contexts

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

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.

Other names: Family/friend Activation to Motivate Self-Care (FAMS; NCT04347291), Family Diabetes Self-Management Education and Support (NCT04334109), Standard Diabetes Self-Management Education and Support (NCT04334109), Diabetes Distress Reduction

print materials

Behavioral

Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters

Primary outcomes

  1. Change in Hemoglobin A1c During Intervention Period

    Time frame: Baseline and 4, 8, and 12 months post-baseline

    Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management

  2. Change in Hemoglobin A1c Sustained Post-intervention Effects

    Time frame: Baseline and 16 months post-baseline

    Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management

Secondary outcomes

  1. Change in Diabetes Distress During Intervention Period

    Time frame: 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)

  2. Change in Diabetes Distress Sustained Post-intervention Effect

    Time frame: 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)

  3. Change in Psychosocial Well-being During Intervention Period

    Time frame: 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)

  4. Change in Psychosocial Well-being Sustained Post-intervention Effect

    Time frame: 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)

Other outcomes

  1. Change in Diabetes Self-efficacy (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better)

  2. Change in Diabetes Self-care Quality (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    Diabetes Self-Management Questionnaire - Revised (DSMQ-R) with scores ranging 0-10 with higher scores indicating more effective self-care behaviors (better)

  3. Change in Dietary Behavior (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    as assessed by Personal Diabetes Questionnaire, Use of Information for Decision Making Scale with scores ranging 1-6 where higher scores indicate more use of dietary information for decision making (better)

  4. Change in Dietary Behavior (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    as assessed by Personal Diabetes Questionnaire, Problem Eating Behavior scale with scores ranging 1-6 where higher scores indicate more problem eating behaviors (worse)

  5. Change in Physical Activity (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    As assessed by the Physical Activity Scale for the Elderly (PASE) with scores ranging 0-400 where higher scores reflect greater levels of physical activity (better)

  6. Change in Physical Activity (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    As assessed by the Exercise Vital Sign (EVS) with scores ranging 0-1,050 minutes per week of moderate to strenuous physical activity where higher scores indicate more physical activity (better)

  7. Change in Diabetes Medication Adherence (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    as assessed by the Summary of Diabetes Self-Care Activities medications subscale with scores ranging 0 to 7 representing days in the prior week with perfect adherence (higher is better)

  8. Change in Diabetes Medication Adherence (Outcome & Mediator)

    Time frame: Baseline and 4, 8, 12, and 16 months post-baseline

    as assessed by the Adherence to Refills and Medications in Diabetes scale, with scores ranging 11-44 with higher scores indicating more problems with adherence (worse)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Alabama at Birmingham

Registry information

Official study title

MObile Support Adapted to Individual Contexts (MOSAIC Study)

Acronym: MOSAIC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 14, 2025
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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