Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596330
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Integration of a Trained Language Model to Improve Glycemic Control Through Increased Physical Activity a Fully Digital My Heart Counts Smartphone App Randomized Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integration of a Trained Language Model to Improve Glycemic Control Through Increased Physical Activity a Fully Digital My Heart Counts Smartphone App Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 preventingtreating T2D and its complications Mean daily steps is a proxy for physical activity with even modest improvements in step count ie 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 individuals 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 1000 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
Physical activity is one of the most potent therapies in preventingtreating T2D and its complications Mean daily steps is a proxy for physical activity with even modest improvements in step count ie 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 individuals 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 1000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None