Obesity, Overweight, Prediabetes
Conditions
Keywords
prediabetes, weight loss, behavior modification
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.
Interventions
BEHAVIORALPrevent
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.
Sponsors
Kresge Foundation
California HealthCare Foundation
University of Southern California
Omada Health, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Weight Loss | baseline, 6 months, 12 months | Percentage of body weight loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | baseline, 6 months, 12 months | fingerstick HbA1C |
Other
| Measure | Time frame | Description |
|---|---|---|
| Program engagement | cumulative (summary total across baseline to 12 months) | Cumulative number of points of engagement with the online program |
Countries
United States
Outcome results
None listed