96
Participants
Start Date
March 2, 2022
Primary Completion Date
March 31, 2026
Study Completion Date
November 30, 2026
Metformin
To begin week 12 for participants who remain prediabetic after 12 week lifestyle run-in. Dosage and Route of Administration: 500 mg dose/ day to be taken orally, increased to 1000 mg dose/ day at week 14 through week 24. The dose should be taken immediately following the evening meal and at approximately the same time daily
Digital Intervention
"Lifestyle Change Digital Intervention - This is a digital platform that will include a core curriculum focused on diet, exercise, and behavioral strategies for goal setting and self-monitoring to improve diet including a weight loss On Day 1, participants will begin their digital lifestyle intervention using their smart-phone application with their lifestyle coach and peer group.~On day 14, participants will be contacted by phone (+/- 4 days, day 10 to 18) and adherence assessed using virtual pill counts via phone calls.~At weeks 4, 8, 16 and 20 a phone-based pill count for adherence and adverse event symptom log will be completed and study medication dispensed.~At week 12 (interim assessment) and 24 (study-end), the participant will return to St. Jude Children's Research Hospital (SJCRH) for an in-person assessment.~The digital lifestyle change program will complete at week 24."
St. Jude Children's Research Hospital, Memphis
St. Baldrick's Foundation
OTHER
Conquer Cancer Foundation
OTHER
National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER