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Clinical Trials/NCT02664064
NCT02664064
Completed
N/A

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

Omada Health, Inc.3 sites in 1 country227 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prediabetes
Sponsor
Omada Health, Inc.
Enrollment
227
Locations
3
Primary Endpoint
% Weight Loss
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
May 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

% Weight Loss

Time Frame: baseline, 6 months, 12 months

Percentage of body weight loss

Secondary Outcomes

  • HbA1c(baseline, 6 months, 12 months)

Study Sites (3)

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