Clinical trial NCT02664064: Evaluation of Prevent in Underserved Populations
Official title: Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Overweight
Obesity
Keywords: prediabetes, weight loss, behavior modification
Lead sponsor: Omada Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kresge Foundation
name: California HealthCare Foundation
name: University of Southern California
First posted: 2016-01-26
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: % Weight Loss
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: HbA1c
timeFrame: baseline, 6 months, 12 months
Other outcomes:
measure: Program engagement
timeFrame: cumulative (summary total across baseline to 12 months)
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: San Fernando
country: United States
facility: Northeast Valley Health Corporation
state: California
city: Monroe
country: United States
facility: Providence Medical Group-Monroe Clinic
state: Washington
Study officials:
affiliation: University of Southern California
name: Michael R Cousineau, DrPh
role: PRINCIPAL_INVESTIGATOR
References: