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

Effectiveness of a Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes: Rationale and Study Protocol - Pilot Study

Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Impaired Glucose Tolerance; Prediabetes; Postprandial Hyperglycemia; Impaired Fasting Glucose
• Intervention / Treatment: Other: Sweetch App Alone; Other: Sweetch App + DBWS

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 GPS (Global Positioning System) 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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • Pennsylvania
    • Reading, Pennsylvania, United States, 19607
      • Reading Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 18 -75 years with prediabetes (fasting 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: Sweetch App + DBWS; Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).
Active Comparator: Sweetch App Alone; Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone.	Other: Sweetch App Alone; Usual care for prediabetes management, Sweetch app alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Yield of Recruitment	Proportion of recruited participants who enroll and complete the 3 month study	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Proportion of enrolled participants who keep app installed and open in background of their smartphones during duration of the study.	3 months
Usability and Satisfaction	Usability and Satisfaction will be measured using an adapted Systems Usability Scale, a validated method of measuring usability with a wide array of technological products, including smartphones.	3 months
Adherence to physical activity goal	Proportion of enrolled participants meeting mean 150 minute per week physical activity target (evaluated at 4 week intervals and over course of entire 12 week study period)	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Sweetch Health, Ltd
• Investigators: Principal Investigator: Adrian S Dobs, MD MHS, Johns Hopkins University

Publications and helpful links

General Publications

• Everett E, Kane B, Yoo A, Dobs A, Mathioudakis N. A Novel Approach for Fully Automated, Personalized Health Coaching for Adults with Prediabetes: Pilot Clinical Trial. J Med Internet Res. 2018 Feb 27;20(2):e72. doi: 10.2196/jmir.9723.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): November 17, 2017
• Study Completion (Actual): November 17, 2017

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Mobile Health
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: IRB00099812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED