Integration of a Trained Language Model to Improve Glycemic Control Through Increased Physical Activity: a Fully Digital My Heart Counts Smartphone App Randomized Trial

Type 2 diabetes (T2D) is one of the most common and fastest growing diseases, affecting 1 in 8 adults (nearly 800 million) worldwide by 2045. Sedentary behavior and increased adiposity are major risk factors for T2D. Cardiovascular disease is the leading cause of death in those with T2D, while diabetic microvascular disease, causing kidney disease, neuropathy, and retinopathy, contributes to T2D morbidity.

Physical activity is one of the most potent therapies in preventing/treating T2D and its complications. Mean daily steps is a proxy for physical activity, with even modest improvements in step count (i.e., +500 steps) associated with decreased T2D and mortality. However, adherence to regular physical activity remains low in T2D patients, with short-term decreases in daily step count associated with impaired glycemic control and T2D recurrence.

The investigators have developed an artificial intelligence (AI) language model (similar to ChatGPT), which can automatically generate coaching prompts to encourage physical activity by incorporating an individual's stage of change. The investigators will extend our research using the My Heart Counts (MHC) smartphone app to 1) validate the efficacy of the AI-generated prompts in patients with T2D and 2) perform a longer-term randomized crossover trial using the language model as a social accountability chatbot - encouraging participants to maintain their physical activity changes over months. The investigators hypothesize that my AI-assisted coaching prompts will significantly increase 1) mean daily step count by 500 steps in 1,000 adults recruited nationwide over a 7-day period, and 2) improve HbA1c and weight via long-term behavior change over a 24-week intervention period.

Study Overview

• Status: Not yet recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Behavioral: Validation of language model prompts in increasing short-term physical activity; Behavioral: Assessment of long-term changes to physical activity and glycemic control

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Kim, MD, PhD, MPH; Phone Number: 650-498-4900; Email: kimds@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals aged ≥18 years old, with a clinical diagnosis of T2D, able to read and understand English, and who are physically able to walk, will be included in our study

Exclusion Criteria:

• Criteria that fall outside of the inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LLM-generated coaching prompt	Behavioral: Validation of language model prompts in increasing short-term physical activity; Aim 1: In preliminary data, the investigators have pre-trained an open-source language model, LLAMA, with expert-created coaching prompts based on the stages of change model for physical activity. Seven different prompts (for each day of an intervention "week") will be generated, accounting for race/ethnicity, age, gender, and stage of change, to improve personalization. Using the existing MHC app, the investigators will perform a randomized crossover trial on mean daily steps across each intervention. The investigators will compare the interventions of a daily reminder to reach 10,000 steps (a neutral control) and AI-personalized interventions based on an individual's stage of change.; Behavioral: Assessment of long-term changes to physical activity and glycemic control; Aim 2: Using social accountability and the trained language model generating personalized coaching interventions, the investigators will conduct a long-term follow-up randomized, unblinded trial. Over a 24-week intervention period, participants will receive either a generic daily reminder to reach 10,000 steps or an AI-generated coaching prompt, with the AI group also being able to "chat" with the language model to ask for advice on maintaining their physical activity. The outcomes of this long-term trial will be change in: 1) daily steps over the intervention period, 2) weight (via HealthKit link to MHC), and 3) HbA1c (as derived from EMR records linked to the HIPAA-compliant MHC app).
Active Comparator: 10,000 Step Reminder	Behavioral: Validation of language model prompts in increasing short-term physical activity; Aim 1: In preliminary data, the investigators have pre-trained an open-source language model, LLAMA, with expert-created coaching prompts based on the stages of change model for physical activity. Seven different prompts (for each day of an intervention "week") will be generated, accounting for race/ethnicity, age, gender, and stage of change, to improve personalization. Using the existing MHC app, the investigators will perform a randomized crossover trial on mean daily steps across each intervention. The investigators will compare the interventions of a daily reminder to reach 10,000 steps (a neutral control) and AI-personalized interventions based on an individual's stage of change.; Behavioral: Assessment of long-term changes to physical activity and glycemic control; Aim 2: Using social accountability and the trained language model generating personalized coaching interventions, the investigators will conduct a long-term follow-up randomized, unblinded trial. Over a 24-week intervention period, participants will receive either a generic daily reminder to reach 10,000 steps or an AI-generated coaching prompt, with the AI group also being able to "chat" with the language model to ask for advice on maintaining their physical activity. The outcomes of this long-term trial will be change in: 1) daily steps over the intervention period, 2) weight (via HealthKit link to MHC), and 3) HbA1c (as derived from EMR records linked to the HIPAA-compliant MHC app).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily steps	Mean daily steps over the course of an intervention week (aim 1) and 24 week period (aim 2).	7 days and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight	Change in weight over the long term intervention (Aim 2)	24 Weeks
Change in HbA1c	Change in HbA1c over the long term intervention (Aim 2)	24 Weeks
Weekly Active Minutes	Total weekly active minutes over the course of an intervention week (aim 1) and 24 week period (aim 2).	7 days and 24 Weeks

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 76338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No