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Evaluation of Prevent in Underserved Populations (PUP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02664064
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
Kresge Foundation
California HealthCare Foundation
University of Southern California
Information provided by (Responsible Party):
Omada Health, Inc.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : January 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. % Weight Loss [ Time Frame: baseline, 6 months, 12 months ]
    Percentage of body weight loss


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: baseline, 6 months, 12 months ]
    fingerstick HbA1C


Other Outcome Measures:
  1. Program engagement [ Time Frame: cumulative (summary total across baseline to 12 months) ]
    Cumulative number of points of engagement with the online program



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664064


Locations
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United States, California
LAC+USC Medical Center
Los Angeles, California, United States, 90033
Northeast Valley Health Corporation
San Fernando, California, United States, 91340
United States, Washington
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
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Principal Investigator: Michael R Cousineau, DrPh University of Southern California

Additional Information:
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Responsible Party: Omada Health, Inc.
ClinicalTrials.gov Identifier: NCT02664064    
Other Study ID Numbers: WIRB20152184
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Omada Health, Inc.:
prediabetes, weight loss, behavior modification
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia