Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02896010|
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : March 27, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|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|
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.
- Yield of Recruitment [ Time Frame: 3 months ]Proportion of recruited participants who enroll and complete the 3 month study
- 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.
- 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.
- 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)
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
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Pennsylvania|
|Reading Health System|
|Reading, Pennsylvania, United States, 19607|
|Principal Investigator:||Nestoras Mathioudakis, MD MHS||Johns Hopkins University|
|Principal Investigator:||Adrian S Dobs, MD MHS||Johns Hopkins University|