PrediabetesNCT02896010
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes
A study testing Sweetch App + DBWS and Sweetch App Alone in people with Prediabetes and Hyperglycemia, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetes, Hyperglycemia, Postprandial Hyperglycemia
- What is being tested?
- Sweetch App + DBWS and Sweetch App Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2016to 17 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Reading Health System
Reading, Pennsylvania, 19607
About this study
Official title: 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.
Read the 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.
- Conditions
- Prediabetes, Hyperglycemia, Postprandial Hyperglycemia, Impaired Glucose Tolerance, Impaired Fasting Glucose
- Being tested
- Sweetch App + DBWS, Sweetch App Alone
- Keywords
- Mobile Health
- Medical subject headings
- Prediabetic State, Hyperglycemia, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweetch App + DBWSOther
Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).
Sweetch App AloneOther
Usual care for prediabetes management, Sweetch app alone.
| Study group | Role | What they receive |
|---|---|---|
| Sweetch App + DBWS | Active comparator | 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). Receives: Other: Sweetch App + DBWS |
| Sweetch App Alone | Active comparator | Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone. Receives: Other: Sweetch App Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yield of Recruitment
Proportion of recruited participants who enroll and complete the 3 month study
Measured: 3 months
Secondary outcomes (3)
Engagement
Proportion of enrolled participants who keep app installed and open in background of their smartphones during duration of the study.
Measured: 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.
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start10 Oct 2016
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Sweetch Health, Ltd
- Responsible party
- Sponsor
- Investigators
- Nestoras Mathioudakis, MD MHS, Principal investigator, Johns Hopkins UniversityAdrian S Dobs, MD MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896010
- Sponsor's protocol ID
- IRB00099812
- Status last verified
- Mar 2018
- First submitted
- 1 Aug 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 29487046
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes: Rationale and Study Protocol - Pilot Study
- ClinicalTrials.gov ID
- NCT02896010
- Acronym / sponsor ID
- IRB00099812
- Conditions
- Prediabetes, Hyperglycemia, Postprandial Hyperglycemia, Impaired Glucose Tolerance, Impaired Fasting Glucose
- Keywords
- Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Sweetch Health, Ltd
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sweetch App + DBWS | Active comparator | Other: Sweetch App + DBWSParticipants 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). |
| Sweetch App Alone | Active comparator | Other: Sweetch App AloneParticipants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweetch App + DBWSUsual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS). | Other | Sweetch App + DBWS |
| Sweetch App AloneUsual care for prediabetes management, Sweetch app alone. | Other | Sweetch App Alone |
Primary outcome
Yield of Recruitment
Time frame: 3 months
Proportion of recruited participants who enroll and complete the 3 month study
3 secondary outcomes
Engagement
Time frame: 3 months
Usability and Satisfaction
Time frame: 3 months
Adherence to physical activity goal
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Derived from this study: PubMed 29487046Everett 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nestoras Mathioudakis, MD MHS principal investigator
Johns Hopkins University
Adrian S Dobs, MD MHS principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweetch App + DBWS and Sweetch App Alone in people with Prediabetes and Hyperglycemia, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yield of Recruitment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.