Evaluation of Prevent in Underserved Populations

Obesity Clinical Trial

— PUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664064
• Other study ID #: WIRB20152184
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 2018

Study information

• Verified date: March 2020
• Source: Omada Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity
• Overweight
• Prediabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	LAC+USC Medical Center	Los Angeles	California
United States	Providence Medical Group-Monroe Clinic	Monroe	Washington
United States	Northeast Valley Health Corporation	San Fernando	California

Sponsors (4)

Lead Sponsor	Collaborator
Omada Health, Inc.	California HealthCare Foundation, Kresge Foundation, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program engagement	Cumulative number of points of engagement with the online program	cumulative (summary total across baseline to 12 months)
Primary	% Weight Loss	Percentage of body weight loss	baseline, 6 months, 12 months
Secondary	HbA1c	fingerstick HbA1C	baseline, 6 months, 12 months

External Links

•   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.