PUP: Evaluation of Prevent in Underserved Populations

• Sponsor: Omada Health, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02664064
• Collaborator: Kresge Foundation (Other), California HealthCare Foundation (Other), University of Southern California (Other)
• Enrollment: 227
• Locations: 3
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 75.7
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prediabetes; Overweight; Obesity	Behavioral: Prevent	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 227 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users
• Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: online Diabetes Prevention Program 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; 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.
No Intervention: Matched Control 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.

Outcome Measures

Primary Outcome Measures

1. % Weight Loss [baseline, 6 months, 12 months]

   Percentage of body weight loss

Secondary Outcome Measures

1. HbA1c [baseline, 6 months, 12 months]

   fingerstick HbA1C

Other Outcome Measures

1. Program engagement [cumulative (summary total across baseline to 12 months)]

   Cumulative number of points of engagement with the online program

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LAC+USC Medical Center	Los Angeles	California	United States	90033
2	Northeast Valley Health Corporation	San Fernando	California	United States	91340
3	Providence Medical Group-Monroe Clinic	Monroe	Washington	United States	98272

Sponsors and Collaborators

• Omada Health, Inc.
• Kresge Foundation
• California HealthCare Foundation
• University of Southern California

Investigators

• Principal Investigator: Michael R Cousineau, DrPh, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Omada is a San Francisco-based healthcare technology company that is pioneering the field of digital behavioral medicine, to fulfill our mission of inspiring and enabling people everywhere to live free of chronic disease.

Publications

None provided.

• Responsible Party: Omada Health, Inc.
• ClinicalTrials.gov Identifier: NCT02664064
• Other Study ID Numbers: WIRB20152184
• First Posted: Jan 26, 2016
• Last Update Posted: Mar 4, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Omada Health, Inc.: prediabetes, weight loss, behavior modification
• Additional relevant MeSH terms: Prediabetic State; Glucose Intolerance; Overweight

Study Results

No Results Posted as of Mar 4, 2020