Evaluation of Prevent in Underserved Populations

Not Applicable

Completed

• Conditions: Prediabetes; Overweight; Obesity
• Interventions: Behavioral: Prevent

• Registration Number: NCT02664064
• Lead Sponsor: Omada Health, Inc.

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Primary Completion: 2018-04
• Study Completion: 2018-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
online Diabetes Prevention Program	Prevent	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.

Primary Outcome Measures

Name	Time	Method
% Weight Loss	baseline, 6 months, 12 months	Percentage of body weight loss

Secondary Outcome Measures

Name	Time	Method
HbA1c	baseline, 6 months, 12 months	fingerstick HbA1C

Trial Locations

Locations (3)

LAC+USC Medical Center; 🇺🇸 Los Angeles, California, United States

Northeast Valley Health Corporation; 🇺🇸 San Fernando, California, United States

Providence Medical Group-Monroe Clinic; 🇺🇸 Monroe, Washington, United States