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OpenTrials
Completed

NCT Number: NCT02664064

Evaluation of Prevent in Underserved Populations

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LAC+USC Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevent

Behavioral

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.

Primary outcomes

  1. % Weight Loss

    Time frame: baseline, 6 months, 12 months

    Percentage of body weight loss

Secondary outcomes

  1. HbA1c

    Time frame: baseline, 6 months, 12 months

    fingerstick HbA1C

Other outcomes

  1. Program engagement

    Time frame: cumulative (summary total across baseline to 12 months)

    Cumulative number of points of engagement with the online program

Sponsors and collaborators

Lead sponsor

Omada Health, Inc.

Industry

Collaborators

  • California HealthCare Foundation
  • Kresge Foundation
  • University of Southern California

Registry information

Official study title

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

Acronym: PUP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2016
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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