Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study

NCT ID: NCT03315663

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-04-19

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.

Conditions

Prediabetes; Hyperglycemia; Postprandial Hyperglycemia; Impaired Glucose Tolerance; Impaired Fasting Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sweetch App + DBWS

Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app plus weight monitoring via digital body weight scale (DBWS).

Group Type: ACTIVE_COMPARATOR

Sweetch App & DBWS

Intervention Type: OTHER

Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).

Sweetch App Alone

Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone.

Group Type: ACTIVE_COMPARATOR

Sweetch App Alone

Intervention Type: OTHER

Usual care for prediabetes management, Sweetch app alone.

Interventions

Sweetch App & DBWS

Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).

Intervention Type: OTHER

Sweetch App Alone

Usual care for prediabetes management, Sweetch app alone.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sweetch Health, Ltd

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian S. Dobs, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Reading Health System

Reading, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB00099813

Identifier Type: -

Identifier Source: org_study_id