Evaluation of Prevent in Underserved Populations (PUP)

March 2, 2020 updated by: Omada Health, Inc.

Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users

The goal of this study is to evaluate an online Diabetes Prevention Program adapted for patients with prediabetes in safety net health care settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Diabetes Prevention Program (DPP) demonstrated that intensive behavioral counseling is a successful approach to reduce the risk of developing diabetes in patients with prediabetes. While the DPP lifestyle intervention was successful and group based adaptations of the DPP have positive results, scalable alternatives that allow for even broader reach are necessary. Omada Health has developed an online, group-based, recognized DPP program (Prevent). The goal of this study is to evaluate a literacy-adapted version of Prevent for patients with prediabetes in safety net health care settings.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • 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
    • California
      • Los Angeles, California, United States, 90033
        • LAC+USC Medical Center
      • San Fernando, California, United States, 91340
        • Northeast Valley Health Corporation
    • Washington
      • Monroe, Washington, United States, 98272
        • Providence Medical Group-Monroe Clinic

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

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • is receiving care at one of the three participating locations
  • prediabetes diagnosis confirmed by lab tests
  • age 18-75 at screening
  • Not insured, Medicaid insured, or safety net health plan insured
  • Comfortable speaking/reading English or Spanish at 5th grade level
  • Body Mass Index greater or equal to 24
  • Able to access the internet weekly by computer or smartphone
  • Able to engage in physical activity of at least moderate intensity
  • Able and willing to give informed consent to participate

Exclusion Criteria:

  • diagnosed with Type 1 or 2 Diabetes Mellitus
  • taking insulin, metformin or other hypoglycemic agent
  • pregnant or planning to become pregnant during trial period
  • unstable life conditions that would preclude full program participation
  • acute, unstable medical or mental health conditions that would preclude program participation
  • inability to engage in physical activity of at least moderate intensity

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: online Diabetes Prevention Program
Participants will receive access to a 12-month online diabetes prevention program modeled after the CDC DPP curriculum. Participants receive online curriculum, access to a live health coach, interactive group message forums, and connected weight and activity monitoring devices.
Behavioral: Prevent
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.
No Intervention: Matched Control
A de-identified dataset of control subjects matched on age, gender, prediabetes diagnosis, body mass index, comorbidities and socioeconomic status will be cultivated for comparison to the active intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% Weight Loss
Time Frame: baseline, 6 months, 12 months
Percentage of body weight loss
baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: baseline, 6 months, 12 months
fingerstick HbA1C
baseline, 6 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program engagement
Time Frame: cumulative (summary total across baseline to 12 months)
Cumulative number of points of engagement with the online program
cumulative (summary total across baseline to 12 months)

Collaborators and Investigators

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

Sponsor

Omada Health, Inc.

Collaborators

University of Southern California
California HealthCare Foundation
Kresge Foundation

Investigators

  • Principal Investigator: Michael R Cousineau, DrPh, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIRB20152184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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