Back to resultsEvaluation of Prevent in Underserved Populations (PUP)
Primary Purpose
Prediabetes, Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevent
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetes focused on measuring prediabetes, weight loss, behavior modification
Eligibility 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
Sites / Locations
- LAC+USC Medical Center
- Northeast Valley Health Corporation
- Providence Medical Group-Monroe Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
online Diabetes Prevention Program
Matched Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
% Weight Loss
Percentage of body weight loss
Secondary Outcome Measures
HbA1c
fingerstick HbA1C
Full Information
NCT ID
NCT02664064
First Posted
January 21, 2016
Last Updated
March 2, 2020
Sponsor
Omada Health, Inc.
Collaborators
Kresge Foundation, California HealthCare Foundation, University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT02664064
Brief Title
Evaluation of Prevent in Underserved Populations
Acronym
PUP
Official Title
Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omada Health, Inc.
Collaborators
Kresge Foundation, California HealthCare Foundation, University of Southern California
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Overweight, Obesity
Keywords
prediabetes, weight loss, behavior modification
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
online Diabetes Prevention Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Matched Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prevent
Intervention Description
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.
Primary Outcome Measure Information:
Title
% Weight Loss
Description
Percentage of body weight loss
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
HbA1c
Description
fingerstick HbA1C
Time Frame
baseline, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Program engagement
Description
Cumulative number of points of engagement with the online program
Time Frame
cumulative (summary total across baseline to 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Cousineau, DrPh
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Northeast Valley Health Corporation
City
San Fernando
State/Province
California
ZIP/Postal Code
91340
Country
United States
Facility Name
Providence Medical Group-Monroe Clinic
City
Monroe
State/Province
Washington
ZIP/Postal Code
98272
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://omadahealth.com
Description
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.
Learn more about this trial
Evaluation of Prevent in Underserved Populations
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