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Preventing Diabetes With Digital Health and Coaching

NCT03312764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 598

Last updated 2021-02-23

No results posted yet for this study

Summary

The goal of this randomized controlled trial is to determine the efficacy of a digital diabetes prevention program for improving weight, glucose control, and secondary risk factors among people with prediabetes compared to an enhanced standard care plus wait-list control. Exploratory assessments of implementation facilitators and barriers will also be completed to determine strategies for integrating external diabetes-prevention interventions within healthcare settings.

Conditions

Interventions

BEHAVIORAL

Online diabetes prevention program

Digital delivery of Intensive behavioral counseling for diabetes prevention and healthy lifestyle management. Recipients have access to online curriculum, a live health coach, group-based communication forums, and connected technology to track weight and physical activity.

BEHAVIORAL

Standard Care

One-on-one or small group sessions with a dietitian or a trained health professional to advise on physical activity, healthful nutrition and risk reduction for diabetes.

Sponsors & Collaborators

  • University of Nebraska

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Omada Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Estabrooks, PhD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-04-30
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03312764 on ClinicalTrials.gov