PrediabetesPUPNCT02664064
Evaluation of Prevent in Underserved Populations
A study testing Prevent in people with Prediabetes and Overweight, run by Omada Health, Inc. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Overweight, Obesity
- What is being tested?
- Prevent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
LAC+USC Medical Center
Los Angeles, California, 90033
Providence Medical Group-Monroe Clinic
Monroe, Washington, 98272
Northeast Valley Health Corporation
San Fernando, California, 91340
About this study
Official title: Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users
The goal of this study is to evaluate an online Diabetes Prevention Program adapted for patients with prediabetes in safety net health care settings.
Read the 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.
- Conditions
- Prediabetes, Overweight, Obesity
- Being tested
- Prevent
- Keywords
- prediabetes, weight loss, behavior modification
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreventBehavioural
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 group | Role | What they receive |
|---|---|---|
| online Diabetes Prevention Program | Experimental | 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. Receives: Behavioral: Prevent |
| Matched Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Weight Loss
Percentage of body weight loss
Measured: baseline, 6 months, 12 months
Secondary outcomes (1)
HbA1c
fingerstick HbA1C
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omada Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kresge Foundation, California HealthCare Foundation, University of Southern California
- Responsible party
- Sponsor
- Investigators
- Michael R Cousineau, DrPh, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664064
- Sponsor's protocol ID
- WIRB20152184
- Acronym
- PUP
- Status last verified
- Mar 2020
- First submitted
- 21 Jan 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Diabetes Prevention Program Adapted for Safety Net Users
- ClinicalTrials.gov ID
- NCT02664064
- Acronym / sponsor ID
- PUP / WIRB20152184
- Conditions
- Prediabetes, Overweight, Obesity
- Keywords
- prediabetes, weight loss, behavior modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Omada Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kresge Foundation, California HealthCare Foundation, University of Southern California
- Study start
- Jan 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online Diabetes Prevention Program | Experimental | Behavioral: PreventParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreventIntensive 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. | Behavioural | online Diabetes Prevention Program |
Primary outcome
% Weight Loss
Time frame: baseline, 6 months, 12 months
Percentage of body weight loss
1 secondary outcome
HbA1c
Time frame: baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R Cousineau, DrPh principal investigator
University of Southern California
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevent in people with Prediabetes and Overweight, run by Omada Health, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Weight Loss (time frame: baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.