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Automated Health Coaching for Type 2 Diabetes (GODART-P&F Trial)
N/A
Recruiting
Led By Mohanraj Thirumalai, PHD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Diagnosis of T2DM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
GODART-P&F Trial Summary
This trial will test a low-cost AI-assisted lifestyle intervention for diabetes in rural areas, which is delivered via landline phone. It will provide knowledge to develop an optimal intervention package in the future.
Who is the study for?
This trial is for adults over 18 with Type 2 Diabetes, who speak and read English, have a doctor's approval to join, and HbA1c levels between 7% to 10.5%. It's not for those pregnant or planning pregnancy, in another diabetes study, on insulin treatment, with recent renal failure or major heart events.Check my eligibility
What is being tested?
The study tests an AI-assisted lifestyle change program aimed at controlling blood sugar in rural areas via regular phone service. Participants receive either automated or human health coaching weekly with varying reward systems to see which method works best.See study design
What are the potential side effects?
Since the interventions involve lifestyle modifications through coaching rather than medication, typical medical side effects are not expected. However, participants may experience stress or frustration if they find it difficult to adhere to the program.
GODART-P&F Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with type 2 diabetes.
GODART-P&F Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Hemoglobin A1C level between screening and 6 months
GODART-P&F Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm 4Experimental Treatment2 Interventions
Fixed Reward + Weekly human coaching
Group II: Arm 3Experimental Treatment2 Interventions
Fixed Reward + Weekly automated coaching
Group III: Arm 2Experimental Treatment2 Interventions
Adaptive Rewards + Weekly human coaching
Group IV: Arm 1Experimental Treatment2 Interventions
Adaptive Rewards + Weekly automated coaching
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,554 Total Patients Enrolled
Mohanraj Thirumalai, PHDPrincipal InvestigatorUniversity of Alabama at Birmingham
Tapan Mehta, PHDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had renal failure in the last 6 months.I am 18 years old or older.You are currently participating in a program to manage diabetes or weight.I am currently being treated with insulin.I have not had a major heart problem in the last 6 months.Your HbA1c levels need to be between 7% and 10.5% for the first phase of the study, and between 8% and 10.5% for the second phase.I have been diagnosed with type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 4
- Group 2: Arm 2
- Group 3: Arm 3
- Group 4: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively participating in this research?
"Affirmative. According to information provided on clinicaltrials.gov, this medical trial commenced recruiting on July 12th 2023 and was last updated two days later. A total of 108 patients are being sought from one site for participation."
Answered by AI
Are there any remaining vacancies in this clinical trial?
"Yes, clinicaltrials.gov confirms that this project is recruiting patients with the trial having been posted on July 12th and modified most recently on July 14th."
Answered by AI
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