Status:
WITHDRAWN
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Sweetch Health, Ltd
Conditions:
Prediabetes
Hyperglycemia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.
Detailed Description
The mobile phone app Sweetch seeks to increase leisure time physical activity rather than formal exercise through the use of a behavioral analytics engine that continuously process various aspects of ...
Eligibility Criteria
Inclusion
- Adults aged 18 -75 years with prediabetes (fasting Blood Glucose (BG) 100-125 mg/dl, A1C 5.7% - 6.4%, or 2 hour BG of 140-199 mg/dl following 75-gram oral glucose tolerance test)
- Body mass index 24 - 40 kg/m2
- English speaker
- Smartphone user (Android or Apple 5s and above)
Exclusion
- Currently doing more than 150 minutes/week of moderate/vigorous physical activity
- Presence of medical conditions that prevent adoption of moderate physical activity
- Use of any glucose-lowering or weight loss medications within the previous 3 months
- Current pregnancy (self-reported) or planning pregnancy during study period (self-reported)
- Presence of any condition that can result in spurious A1C readings (e.g. anemia \[hemoglobin level below lower limit of normal\] secondary to iron, vitamin B12, or folate deficiencies; hemoglobinopathies)
- Use of systemic glucocorticoids
- Use of antipsychotic medications (stable doses for at least three months of anti-depressants or anti-anxiety drugs will be allowed)
- Severe mental illness or learning disability
- Current participation in another clinical trial
- Liver enzymes \>3 x upper limit of normal
- Poor literacy (REALM-R score of 6 or less)
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03315663
Start Date
July 1 2017
End Date
April 19 2019
Last Update
May 16 2019
Active Locations (2)
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1
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
2
Reading Health System
Reading, Pennsylvania, United States, 19607