Evaluation of Prevent in Underserved Populations

Study Overview
=================
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.

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

Conditions
-----------------
Prediabetes, Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Prevent


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: online Diabetes Prevention Program<br>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. | Behavioral: Prevent<br>* 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.<br>|
| No Intervention: Matched Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Weight Loss | Percentage of body weight loss | baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | fingerstick HbA1C | baseline, 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prediabetes, weight loss, behavior modification