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

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02896010
• Other study ID #: IRB00099812
• Status: Completed
• Phase: N/A
• First received: August 1, 2016
• Last updated: March 26, 2018
• Start date: October 10, 2016
• Est. completion date: November 17, 2017

Study information

• Verified date: March 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperglycemia
• Impaired Fasting Glucose
• Impaired Glucose Tolerance
• Postprandial Hyperglycemia
• Prediabetes
• Prediabetic State

Intervention

Other:
• Sweetch App + DBWS
Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).
• Sweetch App Alone
Usual care for prediabetes management, Sweetch app alone.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Reading Health System	Reading	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Sweetch Health, Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yield of Recruitment	Proportion of recruited participants who enroll and complete the 3 month study	3 months
Secondary	Engagement	Proportion of enrolled participants who keep app installed and open in background of their smartphones during duration of the study.	3 months
Secondary	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
Secondary	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