547 Participants Needed

MOSAIC Mobile Program for Type 2 Diabetes

(MOSAIC Trial)

Recruiting at 1 trial location
LS
EM
Overseen ByErin M Bergner, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
Must be taking: Diabetes medications

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be prescribed at least one daily diabetes medication, it seems likely that you can continue your current diabetes treatment.

What data supports the effectiveness of the MOSAIC treatment for Type 2 Diabetes?

Research shows that digital health coaching and mobile health interventions, similar to the MOSAIC treatment, can improve diabetes management. For example, a study found that a digital health coaching program significantly improved insulin resistance in people with Type 2 Diabetes, suggesting that mobile programs can effectively support lifestyle and medication adherence.12345

Is the MOSAIC Mobile Program for Type 2 Diabetes safe for humans?

The safety of mobile health apps, including those for diabetes, is not well-regulated, and there is limited evidence on their safety and effectiveness. Many apps are not adequately assessed for safety, and there are concerns about data security and clinical validity.56789

How is the MOSAIC treatment for Type 2 Diabetes different from other treatments?

The MOSAIC treatment is unique because it uses a mobile app enhanced with virtual coaching to provide personalized, real-time support for managing Type 2 Diabetes. This approach helps overcome common treatment barriers and improves engagement and satisfaction compared to traditional methods.510111213

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.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MOSAIC mobile phone-delivered intervention or print materials for 12 months

12 months
Monthly coaching sessions and ongoing text message support

Follow-up

Participants are monitored for sustained effects on glycemic management and psychosocial well-being

4 months
Assessments every 4 months

Treatment Details

Interventions

  • MOSAIC
Trial Overview The 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Findings from Research

A systematic review of diabetes mobile applications found that while usability ratings from users and experts ranged from 38% to 80%, significant usability issues such as complex navigation and limited functionality were common.
Despite these usability challenges, diabetes apps showed some clinical effectiveness, with reductions in HbA1c levels between 0.15% and 1.9%, indicating potential for improving glycemic control in adults with type 2 diabetes.
Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review.Fu, H., McMahon, SK., Gross, CR., et al.[2022]
The 12-week Healthy at Home digital health coaching program significantly improved insulin resistance in individuals with type 2 diabetes, showing a reduction in HOMA2-IR scores compared to usual care (p = 0.029).
This pilot study suggests that digital health coaching can be an effective and accessible intervention for under-resourced patients with type 2 diabetes, potentially leading to better diabetes management and clinical outcomes.
Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home.Azelton, KR., Crowley, AP., Vence, N., et al.[2021]
Diabetes-related apps combined with virtual coaching can significantly improve glycemic control and promote meaningful behavior changes compared to using apps alone, addressing common treatment barriers effectively.
Users of these enhanced apps report high satisfaction and prolonged engagement, suggesting that virtual coaching may be a valuable tool in diabetes education, although further research is needed to explore its long-term effects across diverse populations.
Virtual Coaching to Enhance Diabetes Care.Ramchandani, N.[2020]

References

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. [2022]
DiabeText, a mobile health intervention to support medication taking and healthy lifestyle in adults with type 2 diabetes: Study protocol for a randomized controlled trial. [2023]
Digital Health Coaching for Type 2 Diabetes: Randomized Controlled Trial of Healthy at Home. [2021]
Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population. [2022]
Virtual Coaching to Enhance Diabetes Care. [2020]
Is the Quality of Mobile Health Applications for Burns Being Adequately Assessed? [2022]
Content Analysis: First-Time Patient User Challenges with Top-Rated Commercial Diabetes Apps. [2022]
Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group. [2020]
Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. [2020]
[Mobile applications for management of Type 2 diabetes]. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Mobile phone-based self-management tools for type 2 diabetes: the few touch application. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
An intensive insulinotherapy mobile phone application built on artificial intelligence techniques. [2021]
Improvement in glycaemic control in patients with type 2 diabetes with treatment using an interactive mobile application - A pilot study from India. [2022]
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