Type 2 DiabetesMOSAICNCT06828549
MObile Support Adapted to Individual Contexts
A study testing MOSAIC and Print Materials in people with Type 2 Diabetes, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- MOSAIC and Print Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 547 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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*
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: MObile Support Adapted to Individual Contexts (MOSAIC Study)
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:
- 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.
- 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- MOSAIC, Print Materials
- Keywords
- family support, social support, text message, mobile health, hemoglobin A1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOSAICBehavioural
Also called 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
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 MaterialsBehavioural
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters
| Study group | Role | What they receive |
|---|---|---|
| MOSAIC | Experimental | 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. Receives: Behavioral: MOSAIC; Behavioral: Print Materials |
| Print Materials | Placebo comparator | 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. Receives: Behavioral: Print Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c During Intervention Period
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
Measured: Baseline and 4, 8, and 12 months post-baseline
Change in Hemoglobin A1c Sustained Post-intervention Effects
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
Measured: Baseline and 16 months post-baseline
Secondary outcomes (4)
Change in Diabetes Distress During Intervention Period
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)
Measured: Baseline and 4, 8, and 12 months post-baseline
Change in Diabetes Distress Sustained Post-intervention Effect
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)
Measured: Baseline and 16 months post-baseline
Change in Psychosocial Well-being During Intervention Period
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)
Measured: Baseline and 4, 8, and 12 months post-baseline
Change in Psychosocial Well-being Sustained Post-intervention Effect
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)
Measured: Baseline 16 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start21 Mar 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 547 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Alabama at Birmingham
- Responsible party
- Principal investigator, Lindsay Mayberry, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828549
- Sponsor's protocol ID
- 242066
- Other IDs
- 1R01DK140190-01
- Acronym
- MOSAIC
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study results are posted on clinical trials, de-identified individual and aggregate survey, clinical, and laboratory data (including raw and recoded data) and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be made publicly available through the Open Science Framework (OSF).
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MObile Support Adapted to Individual Contexts (MOSAIC Study)
- ClinicalTrials.gov ID
- NCT06828549
- Acronym / sponsor ID
- MOSAIC / 242066
- Conditions
- Type 2 Diabetes
- Keywords
- family support, social support, text message, mobile health, hemoglobin A1c
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 547 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Alabama at Birmingham
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOSAIC | Experimental | Behavioral: MOSAIC, Behavioral: Print MaterialsPWD 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. |
| Print Materials | Placebo comparator | Behavioral: Print MaterialsPWD 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (14 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOSAICAlso: 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 ReductionAll 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. | Behavioural | MOSAIC |
| Print MaterialsQuality print materials about diabetes management provided upon enrollment and in quarterly study newsletters | Behavioural | MOSAIC, Print Materials |
Primary outcome
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
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
4 secondary outcomes
Change in Diabetes Distress During Intervention Period
Time frame: Baseline and 4, 8, and 12 months post-baseline
Change in Diabetes Distress Sustained Post-intervention Effect
Time frame: Baseline and 16 months post-baseline
Change in Psychosocial Well-being During Intervention Period
Time frame: Baseline and 4, 8, and 12 months post-baseline
Change in Psychosocial Well-being Sustained Post-intervention Effect
Time frame: Baseline 16 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. After study results are posted on clinical trials, de-identified individual and aggregate survey, clinical, and laboratory data (including raw and recoded data) and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be made publicly available through the Open Science Framework (OSF).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOSAIC and Print Materials in people with Type 2 Diabetes, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c During Intervention Period (time frame: Baseline and 4, 8, and 12 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.