NCT02896010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

October 10, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

August 1, 2016

Last Update Submit

March 26, 2018

Conditions

PrediabetesHyperglycemiaPostprandial HyperglycemiaImpaired Glucose ToleranceImpaired Fasting Glucose

Keywords

Mobile Health

Outcome Measures

Primary Outcomes (1)

  • Yield of Recruitment

    Proportion of recruited participants who enroll and complete the 3 month study

    3 months

Secondary Outcomes (3)

  • Engagement

    3 months

  • Usability and Satisfaction

    3 months

  • Adherence to physical activity goal

    3 months

Study Arms (2)

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).

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.

Other: Sweetch App Alone

Interventions

Sweetch App + DBWSOTHER

Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).

Sweetch App + DBWS
Sweetch App AloneOTHER

Usual care for prediabetes management, Sweetch app alone.

Sweetch App Alone

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Reading Health System

Reading, Pennsylvania, 19607, United States

Location

Related Publications (1)

  • 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.

    PMID: 29487046DERIVED

MeSH Terms

Conditions

Prediabetic StateHyperglycemiaGlucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nestoras Mathioudakis, MD MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Adrian S Dobs, MD MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

September 12, 2016

Study Start

October 10, 2016

Primary Completion

November 17, 2017

Study Completion

November 17, 2017

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

US(2)