GODART Pilot and Feasibility

NCT05344859 | Completed

• 3 other identifiers: IRB-3000087525R01DK129378-035R01DK129378-02
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (4)

Arm 1

EXPERIMENTAL

Adaptive Rewards + Weekly automated coaching

Behavioral: Weekly Automated Health Coaching; Behavioral: Adapted Reward Level

Arm 2

EXPERIMENTAL

Adaptive Rewards + Weekly human coaching

Behavioral: Weekly Human Health Coaching; Behavioral: Adapted Reward Level

Arm 3

EXPERIMENTAL

Fixed Reward + Weekly automated coaching

Behavioral: Weekly Automated Health Coaching; Behavioral: Fixed Gamified Reward Level

Arm 4

EXPERIMENTAL

Fixed Reward + Weekly human coaching

Behavioral: Weekly Human Health Coaching; Behavioral: Fixed Gamified Reward Level

Interventions

Weekly Automated Health Coaching BEHAVIORAL

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.

Arm 1; Arm 3

Weekly Human Health Coaching BEHAVIORAL

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.

Arm 2; Arm 4

Adapted Reward Level BEHAVIORAL

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 1; Arm 2

Fixed Gamified Reward Level BEHAVIORAL

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 3; Arm 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Department of Family and Community Medicine, University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Related Publications (1)

• 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.

  PMID: 41348456 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tapan Mehta, PHD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Mohanraj Thirumalai, PHD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician and the assessor will be blinded/masked to participant assignment. The health coach will not be blinded. It will not be possible to blind the participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair for Research, Department of Family and Community Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: May 15, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)