Clinical trial NCT03315663: Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study
Official title: Effectiveness and Safety of a Smartphone-Assisted Personalized Intervention Program to Reduce Diabetes Risk in Adults With Prediabetes: a Multi-Center, Open-Label Randomized Controlled Trial - Main Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prediabetes
Hyperglycemia
Postprandial Hyperglycemia
Impaired Glucose Tolerance
Impaired Fasting Glucose
Keywords: Mobile Health
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Sweetch Health, Ltd
First posted: 2017-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This Pivotal Study will be a multicenter, parallel group, open-label randomized controlled trial with a planned period of 12-month follow-up with the primary effectiveness endpoint assessed at 6 months to compare Sweetch's mHealth Personalized Intervention Program (PIP) to usual care for adults with prediabetes. We intend to enroll 155 subjects in each arm, for a total of 310 subjects in this Study. Subjects will attend a total of 3 visits during the study period with point-of-care measurement of A1C at each study visit (0, 6, and 12 months). A difference in change in A1c of 0.1 between the intervention and control arms and in favor of the intervention arm will be considered clinically meaningful.
Primary purpose: SUPPORTIVE_CARE

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 the user's life habits, taking into account the user's demographics, behavioral change status, schedule, actual activity patterns, and more. The rationale behind this approach is that long-term adherence and patient engagement are more likely to be achieved when demands on manual user data entry are kept at a minimum. Compared to similar smartphone-assisted prevention apps, there are two novel features of the Sweetch app that may increase its efficacy. First, it uses a "just-in-time" adaptive intervention" approach that tailors recommendations to the user's day-to-day routine and his or her readiness for behavioral change. Second, and most importantly, it requires no direct involvement by the user, since all the necessary data is collected using built-in tracking pedometers, accelerometer and Global Positioning System (GPS) sensors on smartphones. In contrast, interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient content), require active user tracking at every meal, which is difficult to maintain in the long-term even with the use of sophisticated, electronic calorie counting tools. For these reasons, the Sweetch app may achieve greater long-term adherence, which is usually a limiting factor to efficacy of mobile health interventions.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Safety of Sweetch's PIP compared to usual care to lower A1C
timeFrame: 2 years
measure: Effectiveness of Sweetch's PIP compared to usual care to lower A1C
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of whether intervention increases physical activity.
timeFrame: 12 months
measure: Evaluation of whether intervention reduces weight.
timeFrame: 12 months
measure: Evaluation of whether intervention reduces waist circumference.
timeFrame: 12 months
measure: Evaluation of whether intervention reduces blood pressure.
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Reading
country: United States
facility: Reading Health System
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Adrian S. Dobs, MD MHS
role: PRINCIPAL_INVESTIGATOR
References: