GODART Pilot and Feasibility

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

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

  collaborator NIH

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Tapan Mehta, PHD · University of Alabama at Birmingham

• Mohanraj Thirumalai, PHD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-15

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• United States

Study Locations