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

May 14, 2019 updated by: Johns Hopkins University

Effectiveness and Safety of a Smartphone-Assisted Personalized Intervention Program to Reduce Diabetes Risk in Adults With Prediabetes: a Multi-Center, Open-Label Randomized Controlled Trial - Main 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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of Sweetch's PIP compared to usual care to lower A1C
Time Frame: 2 years
Administration of study intervention will be halted when 3 grade 3 Adverse Events (AEs) determined to be "probably related" are reported to the Data Coordinating Center (DCC). The DCC will notify study sponsor & investigators immediately when the third grade 3 event is reported & enrollment screens will stop accepting new study participants. Study sponsor will inform the Data Safety and Monitoring Board (DSMB) members within 24 hours of this occurrence & will provide DSMB with AE listing reports. The DSMB will convene an ad hoc meeting by teleconference or in writing as soon as possible. The DSMB will provide recommendations for proceeding with the study to study sponsor. If Sweetch Health determines that an unanticipated adverse device effect presents an unreasonable risk to subjects, investigations or parts of investigations presenting that risk will be terminated as soon as possible.
2 years
Effectiveness of Sweetch's PIP compared to usual care to lower A1C
Time Frame: 2 years
A1C is a continuous measure expressed in units of % and mmol/mol. Change in A1C will be calculated by subtracting the 6-month result from the baseline result. The primary effectiveness endpoint will be analyzed using linear regression models, where change in A1C at 6 months will be the dependent variable and treatment group will be the primary predictor variable. The baseline value of the outcome measure will be included as a covariate.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of whether intervention increases physical activity.
Time Frame: 12 months
Through the use of built-in accelerometers and pedometers on smartphones, the study will evaluate the percentage of weekly activity goals (individualized per subject) achieved per subject (range from 60 minutes to 150 minutes per week), proportion of subjects achieving 150 minutes of weekly activity taken as the average of months 4-6 at the 6-month time point, and average of months 7-12 at the 12-month time point. In addition, mean minutes of physical activity per week will be evaluated over intervals between study time points. Physical activity measures will be reported only in the intervention arm, since tracking of physical activity will not be possible in the control arm.
12 months
Evaluation of whether intervention reduces weight.
Time Frame: 12 months
Users update manually or weight data is synced from the digital scale. Data points measured are net weight change from baseline to 6 and 12 months; percentage weight change from baseline to 6 and 12 months; and proportion of subjects achieving 5% body weight loss at 6 and 12 months.
12 months
Evaluation of whether intervention reduces waist circumference.
Time Frame: 12 months
Waist circumference will be measured using a flexible tape measure according to the technique recommended by the American Society for Nutrition. We will evaluate percentage change in waist circumference from baseline to 6 and 12 month time points. The null hypothesis is that there is no difference between percentage change at 6 and 12 months between the intervention and control groups and the alternative hypothesis is that there is a greater percentage change in waist circumference from baseline in the intervention group.
12 months
Evaluation of whether intervention reduces blood pressure.
Time Frame: 12 months
Blood pressure will be measured in accordance with recommendations by the American Heart Association. Changes in systolic and diastolic blood pressure from baseline to 6 and 12 months. Systolic (SBP) and diastolic blood pressure (DBP) will be evaluated as separate continuous measures. The null hypothesis is that changes in SBP and DBP are no different between groups at both time points and the alternative hypothesis is that there is a greater reduction in SBP and DBP in the intervention group. Assuming a variance of 10.1 for change in SBP38 and a change of -1 mmHg in the control arm, the study would have 83% power to detect a between-group difference of 4 mmHg in SBP, which would be considered clinically meaningful. Assuming a variance of 7 for change in DBP and a change of -1 mmHg in the control arm38, the study would have 81% power to detect a between-group difference of 2.7 mmHg in DBP, which would be considered clinically meaningful.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sweetch Health, Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrian S. Dobs, MD MHS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00099813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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