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

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ClinicalTrials.gov Identifier: NCT02896010
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Sweetch Health, Ltd
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Prediabetes Hyperglycemia Postprandial Hyperglycemia Impaired Glucose Tolerance Impaired Fasting Glucose Other: Sweetch App + DBWS Other: Sweetch App Alone Not Applicable

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  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of a Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes: Rationale and Study Protocol - Pilot Study
Actual Study Start Date : October 10, 2016
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : November 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




Primary Outcome Measures :
  1. Yield of Recruitment [ Time Frame: 3 months ]
    Proportion of recruited participants who enroll and complete the 3 month study


Secondary Outcome Measures :
  1. Engagement [ Time Frame: 3 months ]
    Proportion of enrolled participants who keep app installed and open in background of their smartphones during duration of the study.

  2. Usability and Satisfaction [ Time Frame: 3 months ]
    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. Adherence to physical activity goal [ Time Frame: 3 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896010


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Pennsylvania
Reading Health System
Reading, Pennsylvania, United States, 19607
Sponsors and Collaborators
Johns Hopkins University
Sweetch Health, Ltd
Investigators
Principal Investigator: Nestoras Mathioudakis, MD MHS Johns Hopkins University
Principal Investigator: Adrian S Dobs, MD MHS Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02896010     History of Changes
Other Study ID Numbers: IRB00099812
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Johns Hopkins University:
Mobile Health

Additional relevant MeSH terms:
Hyperglycemia
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases