An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

November 30, 2026

Conditions
PreDiabetesAdult Children
Interventions
DRUG

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

BEHAVIORAL

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."

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
collaborator

St. Baldrick's Foundation

OTHER

collaborator

Conquer Cancer Foundation

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

St. Jude Children's Research Hospital

OTHER