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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 : March 4, 2020
Sponsor:
Collaborators:
Kresge Foundation
California HealthCare Foundation
University of Southern California
Information provided by (Responsible Party):
Omada Health, Inc.

Tracking Information
First Submitted Date  ICMJE January 21, 2016
First Posted Date  ICMJE January 26, 2016
Last Update Posted Date March 4, 2020
Study Start Date  ICMJE January 2016
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
% Weight Loss [ Time Frame: baseline, 6 months, 12 months ]
Percentage of body weight loss
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
HbA1c [ Time Frame: baseline, 6 months, 12 months ]
fingerstick HbA1C
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 21, 2016)
Program engagement [ Time Frame: cumulative (summary total across baseline to 12 months) ]
Cumulative number of points of engagement with the online program
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Prevent in Underserved Populations
Official Title  ICMJE Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Prediabetes
  • Overweight
  • Obesity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Prevent
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2020)
227
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2016)
300
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02664064
Other Study ID Numbers  ICMJE WIRB20152184
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Omada Health, Inc.
Study Sponsor  ICMJE Omada Health, Inc.
Collaborators  ICMJE
  • Kresge Foundation
  • California HealthCare Foundation
  • University of Southern California
Investigators  ICMJE
Principal Investigator: Michael R Cousineau, DrPh University of Southern California
PRS Account Omada Health, Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP