Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2023-05-15
2025-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Arm 1
Adaptive Rewards + Weekly automated coaching
Weekly Automated Health Coaching
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.
Adapted Reward Level
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.
Arm 2
Adaptive Rewards + Weekly human coaching
Weekly Human Health Coaching
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 Level
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.
Arm 3
Fixed Reward + Weekly automated coaching
Weekly Automated Health Coaching
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.
Fixed Gamified Reward Level
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.
Arm 4
Fixed Reward + Weekly human coaching
Weekly Human Health Coaching
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.
Fixed Gamified Reward Level
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.
Interventions
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Weekly Automated Health Coaching
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 Coaching
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 Level
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 Level
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.
Eligibility Criteria
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Inclusion Criteria
2. HbA1C ≥7% to ≤ 10.5% for phase 1- 14 days and phase 2 of the study- 6 months.
3. ≥18 years of age
4. the ability to converse in and read English.
Exclusion Criteria
2. Current enrollment in any structured lifestyle intervention study for diabetes or weight management.
3. Patients currently on insulin treatment
4. Major cardiac event in the past 6 months
5. Renal failure in the past 6 months
6. Listening and Speaking Impairment
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Alabama at Birmingham
OTHER
Responsible Party
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Tapan Shirish Mehta
Professor, Vice Chair for Research, Department of Family and Community Medicine
Principal Investigators
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Tapan Mehta, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Mohanraj Thirumalai, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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Department of Family and Community Medicine, University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Mehta 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.
Other Identifiers
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