Diabetes Mellitus, Type 2GODART-P&FNCT05344859
GODART Pilot and Feasibility
A study testing Weekly Automated Health Coaching, Weekly Human Health Coaching and Adapted Reward Level in people with Diabetes Mellitus, Type 2, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Weekly Automated Health Coaching, Weekly Human Health Coaching and Adapted Reward Level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of T2DM
- HbA1C ≥7% to ≤ 10.5% for phase 1- 14 days and phase 2 of the study- 6 months.
- ≥18 years of age
- the ability to converse in and read English.
Who cannot join
- Present or soon-planned pregnancy
- Current enrollment in any structured lifestyle intervention study for diabetes or weight management.
- Patients currently on insulin treatment
- Major cardiac event in the past 6 months
- Renal failure in the past 6 months
- Listening and Speaking Impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Family and Community Medicine, University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
Official title: A Feasibility and Pilot Trial of Gamification and AI-based Health Coaching Intervention Components for Diabetes Management Using the GODART Platform
The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. This study will provide us with the knowledge to plan a well-powered optimization trial in the future to develop an optimal (low-cost) intervention package that can be delivered in a sustainable manner to the rural portions of America.
Read the detailed description
Evidence-based guidelines for type 2 diabetes mellitus (T2DM) management aimed at glycemic control (reduced hemoglobin A1c) include a combination of diet, physical activity (PA), glucose monitoring, and medication adherences. However, the majority of individuals with T2DM are unable to follow these guidelines due to a lack of consistent health behavior counseling offered in the primary care setting. This problem is amplified in remote rural communities within the U.S. In response, this project aims to create an optimized telehealth-based intervention - Gamified Optimized Diabetes management with Artificial Intelligence-powered Rural Telehealth (GODART). GODART is grounded in the social cognitive theory and will serve as an automated behavior-monitoring and telecoaching platform. At the core, GODART is an automated conversational-style behavior-monitoring system using natural language-understanding technologies. In this project, we propose to pilot and feasibility test the various components of GODART by leveraging a multiphase optimization strategy (MOST). MOST is an efficient and rigorous resource-management and continuous- improvement framework for developing optimized interventions. Our proposal focuses on the MOST preparatory phase and will use full factorial experimentation. We will pilot and assess the feasibility of and evaluate two different intervention components, with two levels in each of the groups, yielding four experimental conditions. These groups will test the effect of (i) a fixed vs. adaptive (gamified) rewards program and (ii) automated vs. human-delivered weekly health coaching. We will end the project with exit interviews conducted with a subset of participants. Study findings will help us learn the feasibility of delivering such an intervention and its preliminary effectiveness in reducing HbA1c, leading to adequately powered confirmatory effectiveness studies.
Participants will be enrolled in the study in 2 phases:
Phase 1-The Feasibility Phase: Up to 16 participants will be enrolled in this phase of the study. Participants will be in the study for a duration of 14 days. This phase of the study is conducted to access the feasibility, usability, and accessibility of the GODART platform, before the actual intervention phase.
Phase 2- Intervention Phase: 88 participants will be enrolled in this phase of the study for a duration of 6 months.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Weekly Automated Health Coaching, Weekly Human Health Coaching, Adapted Reward Level, Fixed Gamified Reward Level
- 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.
Weekly Automated Health CoachingBehavioural
This intervention will involve health coaching delivered by Artificial intelligence (AI). The automated health coaching mechanism will be coupled with AI-based responses, and recent advancements have made the voices generated through the AI, almost human-like voices. Every week participants enrolled in automated health coaching intervention will receive a health coaching and goal-setting call that will help guide the participants in managing their Type 2 Diabetes Mellitus. This technology-driven study group will inform us whether trained human coaches are required or if the automated technologies are sufficient to create clinically meaningful HbA1c improvements.
Weekly Human Health CoachingBehavioural
Every week participants enrolled in human health coaching intervention will receive a health coaching call and goal-setting call from their respective health coaches to guide them in managing their Type 2 Diabetes Mellitus.
Adapted Reward LevelBehavioural
In the adapted reward (gamified) variation, participants will receive 25 cents per day for the first week of daily-monitoring calls, 50 cents per day in the second week, 75 cents per day in the third week, and a dollar per day from the fourth week until the end of the study (Aim 2). In the adaptive variation, missing one day of monitoring (in the past seven days), drops the reward value by one level (example: 75 cents becomes 50 cents), two days of missed calls drop the reward level by two levels, and similarly for three days. In the adaptive variation, participants have to continue to daily monitor their behavior to again build up their reward levels.
Fixed Gamified Reward LevelBehavioural
In our fixed-reward arm, participants will be awarded 25 cents per day for answering the daily monitoring call - this serves simply as a reward for answering the daily calls. It is important that the rewards are for answering the calls and not for the actual values of the responses provided.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Adaptive Rewards + Weekly automated coaching Receives: Behavioral: Weekly Automated Health Coaching; Behavioral: Adapted Reward Level |
| Arm 2 | Experimental | Adaptive Rewards + Weekly human coaching Receives: Behavioral: Weekly Human Health Coaching; Behavioral: Adapted Reward Level |
| Arm 3 | Experimental | Fixed Reward + Weekly automated coaching Receives: Behavioral: Weekly Automated Health Coaching; Behavioral: Fixed Gamified Reward Level |
| Arm 4 | Experimental | Fixed Reward + Weekly human coaching Receives: Behavioral: Weekly Human Health Coaching; Behavioral: Fixed Gamified Reward Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C level between screening and 6 months
The inclusion criteria for a participant enrolling in the study is HbA1c ≥ 7% to ≤10.5% (for phase 1) and HbA1c ≥ 7% to ≤10.5% (phase 2). The primary outcome of the study is to track change in the HbA1C between baseline and 6 months (primary endpoint of the study). The HbA1C will be tested at baseline and 6 months. The measure of HbA1C at the end of 6 months (end of the intervention period) will be considered as the primary outcome measure to study the effectiveness of the interventions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 May 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- We propose to use the multiphase optimization strategy (MOST) design, as an ideal approach for the study, that is based on the principle of resource management and continuous improvement. Our study aim aligns with the preparatory and optimization phases of MOST, and is structured to serve as the preparatory phase for a future large-scale MOST optimization phase.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tapan Shirish Mehta, University of Alabama at Birmingham
- Investigators
- Tapan Mehta, PHD, Principal investigator, University of Alabama at BirminghamMohanraj Thirumalai, PHD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344859
- Sponsor's protocol ID
- IRB-300008752
- Other IDs
- 5R01DK129378-03, 5R01DK129378-02
- Acronym
- GODART-P&F
- Status last verified
- Dec 2025
- First submitted
- 18 Apr 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
John T, Mohanraj S, Nawshin T, Mehta T, Thirumalai M. Bridging the Digital Divide in Diabetes Care With an AI-Powered Health Coaching Intervention: Qualitative Formative Study. JMIR Diabetes. 2026 Aug 7;11:e81441. doi: 10.2196/81441.
PubMed 42566713Mehta T, John T, El Zein A, Faught V, Nawshin T, Chilke TS, Cohen CW, Cherrington A, Thirumalai M. Gamified Optimized Diabetes Management With Artificial Intelligence-Powered Rural Telehealth Intervention (GODART): Protocol for an Optimization Pilot and Feasibility Trial. JMIR Res Protoc. 2025 Dec 5;14:e70271. doi: 10.2196/70271.
PubMed 41348456
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Pilot Trial of Gamification and AI-based Health Coaching Intervention Components for Diabetes Management Using the GODART Platform
- ClinicalTrials.gov ID
- NCT05344859
- Acronym / sponsor ID
- GODART-P&F / IRB-300008752
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 25 Apr 2022 (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.
The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. This study will provide us with the knowledge to plan a well-powered optimization trial in the future to develop an optimal (low-cost) intervention package that can be delivered in a sustainable manner to the rural portions of America.
Detailed description
Evidence-based guidelines for type 2 diabetes mellitus (T2DM) management aimed at glycemic control (reduced hemoglobin A1c) include a combination of diet, physical activity (PA), glucose monitoring, and medication adherences. However, the majority of individuals with T2DM are unable to follow these guidelines due to a lack of consistent health behavior counseling offered in the primary care setting. This problem is amplified in remote rural communities within the U.S. In response, this project aims to create an optimized telehealth-based intervention - Gamified Optimized Diabetes management with Artificial Intelligence-powered Rural Telehealth (GODART). GODART is grounded in the social cognitive theory and will serve as an automated behavior-monitoring and telecoaching platform. At the core, GODART is an automated conversational-style behavior-monitoring system using natural language-understanding technologies. In this project, we propose to pilot and feasibility test the various components of GODART by leveraging a multiphase optimization strategy (MOST). MOST is an efficient and rigorous resource-management and continuous- improvement framework for developing optimized interventions. Our proposal focuses on the MOST preparatory phase and will use full factorial experimentation. We will pilot and assess the feasibility of and evaluate two different intervention components, with two levels in each of the groups, yielding four experimental conditions. These groups will test the effect of (i) a fixed vs. adaptive (gamified) rewards program and (ii) automated vs. human-delivered weekly health coaching. We will end the project with exit interviews conducted with a subset of participants. Study findings will help us learn the feasibility of delivering such an intervention and its preliminary effectiveness in reducing HbA1c, leading to adequately powered confirmatory effectiveness studies.
Participants will be enrolled in the study in 2 phases:
Phase 1-The Feasibility Phase: Up to 16 participants will be enrolled in this phase of the study. Participants will be in the study for a duration of 14 days. This phase of the study is conducted to access the feasibility, usability, and accessibility of the GODART platform, before the actual intervention phase.
Phase 2- Intervention Phase: 88 participants will be enrolled in this phase of the study for a duration of 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- We propose to use the multiphase optimization strategy (MOST) design, as an ideal approach for the study, that is based on the principle of resource management and continuous improvement. Our study aim aligns with the preparatory and optimization phases of MOST, and is structured to serve as the preparatory phase for a future large-scale MOST optimization phase.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Weekly Automated Health Coaching, Behavioral: Adapted Reward LevelAdaptive Rewards + Weekly automated coaching |
| Arm 2 | Experimental | Behavioral: Weekly Human Health Coaching, Behavioral: Adapted Reward LevelAdaptive Rewards + Weekly human coaching |
| Arm 3 | Experimental | Behavioral: Weekly Automated Health Coaching, Behavioral: Fixed Gamified Reward LevelFixed Reward + Weekly automated coaching |
| Arm 4 | Experimental | Behavioral: Weekly Human Health Coaching, Behavioral: Fixed Gamified Reward LevelFixed Reward + Weekly human coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of T2DM
- HbA1C ≥7% to ≤ 10.5% for phase 1- 14 days and phase 2 of the study- 6 months.
- ≥18 years of age
- the ability to converse in and read English.
Key exclusion criteria (6 listed)
- Present or soon-planned pregnancy
- Current enrollment in any structured lifestyle intervention study for diabetes or weight management.
- Patients currently on insulin treatment
- Major cardiac event in the past 6 months
- Renal failure in the past 6 months
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 |
|---|---|---|
| Weekly Automated Health CoachingThis intervention will involve health coaching delivered by Artificial intelligence (AI). The automated health coaching mechanism will be coupled with AI-based responses, and recent advancements have made the voices generated through the AI, almost human-like voices. Every week participants enrolled in automated health coaching intervention will receive a health coaching and goal-setting call that will help guide the participants in managing their Type 2 Diabetes Mellitus. This technology-driven study group will inform us whether trained human coaches are required or if the automated technologies are sufficient to create clinically meaningful HbA1c improvements. | Behavioural | Arm 1, Arm 3 |
| Weekly Human Health CoachingEvery week participants enrolled in human health coaching intervention will receive a health coaching call and goal-setting call from their respective health coaches to guide them in managing their Type 2 Diabetes Mellitus. | Behavioural | Arm 2, Arm 4 |
| Adapted Reward LevelIn the adapted reward (gamified) variation, participants will receive 25 cents per day for the first week of daily-monitoring calls, 50 cents per day in the second week, 75 cents per day in the third week, and a dollar per day from the fourth week until the end of the study (Aim 2). In the adaptive variation, missing one day of monitoring (in the past seven days), drops the reward value by one level (example: 75 cents becomes 50 cents), two days of missed calls drop the reward level by two levels, and similarly for three days. In the adaptive variation, participants have to continue to daily monitor their behavior to again build up their reward levels. | Behavioural | Arm 1, Arm 2 |
| Fixed Gamified Reward LevelIn our fixed-reward arm, participants will be awarded 25 cents per day for answering the daily monitoring call - this serves simply as a reward for answering the daily calls. It is important that the rewards are for answering the calls and not for the actual values of the responses provided. | Behavioural | Arm 3, Arm 4 |
Primary outcome
Change in Hemoglobin A1C level between screening and 6 months
Time frame: 6 months
The inclusion criteria for a participant enrolling in the study is HbA1c ≥ 7% to ≤10.5% (for phase 1) and HbA1c ≥ 7% to ≤10.5% (phase 2). The primary outcome of the study is to track change in the HbA1C between baseline and 6 months (primary endpoint of the study). The HbA1C will be tested at baseline and 6 months. The measure of HbA1C at the end of 6 months (end of the intervention period) will be considered as the primary outcome measure to study the effectiveness of the interventions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 42566713John T, Mohanraj S, Nawshin T, Mehta T, Thirumalai M. Bridging the Digital Divide in Diabetes Care With an AI-Powered Health Coaching Intervention: Qualitative Formative Study. JMIR Diabetes. 2026 Aug 7;11:e81441. doi: 10.2196/81441.
- Derived from this study: PubMed 41348456Mehta T, John T, El Zein A, Faught V, Nawshin T, Chilke TS, Cohen CW, Cherrington A, Thirumalai M. Gamified Optimized Diabetes Management With Artificial Intelligence-Powered Rural Telehealth Intervention (GODART): Protocol for an Optimization Pilot and Feasibility Trial. JMIR Res Protoc. 2025 Dec 5;14:e70271. doi: 10.2196/70271.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tapan Mehta, PHD principal investigator
University of Alabama at Birmingham
Mohanraj Thirumalai, PHD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly Automated Health Coaching, Weekly Human Health Coaching and Adapted Reward Level in people with Diabetes Mellitus, Type 2, run by University of Alabama at Birmingham at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 level between screening and 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344859, which also lists 2 linked publications.
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 17 Dec 2025.