Evaluation of Prevent in Underserved Populations (PUP)

Omada Health

Status: Completed

Conditions: Prediabetes; Overweight; Obesity

Treatments: Behavioral: Prevent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02664064

WIRB20152184

Details and patient eligibility

About

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

Full 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.

Enrollment: 227 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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227 participants in 2 patient groups

online Diabetes Prevention Program

Experimental group

Description:

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.

Treatment:

Behavioral: Prevent

Matched Control

No Intervention group

Description:

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.