Evaluation of Prevent in Underserved Populations
PUP
Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users
1 other identifier
interventional
227
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMarch 4, 2020
March 1, 2020
2.2 years
January 21, 2016
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% Weight Loss
Percentage of body weight loss
baseline, 6 months, 12 months
Secondary Outcomes (1)
HbA1c
baseline, 6 months, 12 months
Other Outcomes (1)
Program engagement
cumulative (summary total across baseline to 12 months)
Study Arms (2)
online Diabetes Prevention Program
EXPERIMENTALParticipants 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.
Matched Control
NO INTERVENTIONA 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Omada Health, Inc.lead
- Kresge Foundationcollaborator
- California HealthCare Foundationcollaborator
- University of Southern Californiacollaborator
Study Sites (3)
LAC+USC Medical Center
Los Angeles, California, 90033, United States
Northeast Valley Health Corporation
San Fernando, California, 91340, United States
Providence Medical Group-Monroe Clinic
Monroe, Washington, 98272, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Cousineau, DrPh
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2016
First Posted
January 26, 2016
Study Start
January 1, 2016
Primary Completion
April 1, 2018
Study Completion
May 1, 2018
Last Updated
March 4, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share