PreDiabetesPREDICTSNCT03312764
Preventing Diabetes With Digital Health and Coaching
A study testing Online diabetes prevention program in people with PreDiabetes, run by Omada Health, Inc. at 1 site in United States.
Trial summary
The goal of this randomized controlled trial is to determine the efficacy of a digital diabetes prevention program for improving weight, glucose control, and secondary risk factors among people with prediabetes compared to an enhanced standard care plus wait-list control. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Online diabetes prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 31 Aug 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receives care at University of Nebraska Medical Center or Nebraska Medicine
- Age 19 years or older
- HbA1c 5.7%-6.4%
- Overweight (BMI 25+ or 22+ if Asian)
- Planning to reside in recruitment area for next 12 months
- Able to engage in moderate aerobic physical activity
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- Medically stable
- Able to provide informed consent
- Willing to accept random assignment to treatment
Who cannot join
- Not meeting all inclusion criteria
- Diagnosed with Type I or II diabetes
- Diagnosed with congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, pulmonary hypertension
- Diagnosed with dementia or probable Alzheimer's disease
- Taking oral hypoglycemic agents
- Participating in a concurrent weight management program or interventional research protocol
Show all 18Show fewer
- Unable to engage in physical activity
- On a prescribed medical diet
- Had bariatric surgery within the past 3 years or planning surgery within the next 12 months
- Anti-obesity or diabetes therapy within the preceding 4 months
- Any mental health condition, including eating disorders or alcohol/substance use, which would preclude full participation
- Self-report as currently pregnant or within 6 weeks of having given birth (or planning to become pregnant in the next 12 months)
- Unstable cardiac disease (i.e. heart attack/failure or stroke in the last 6 months, or in cardiac rehabilitation)
- On dialysis or an active organ transplant list
- Chronic kidney disease
- Untreated thyroid disease
- Cancer within the last 5 years unless skin cancer (i.e. currently or within the last 5 years in chemotherapy or radiation treatment)
- Unwilling to accept random assignment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198-4365
About this study
Official title: Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)
The goal of this randomized controlled trial is to determine the efficacy of a digital diabetes prevention program for improving weight, glucose control, and secondary risk factors among people with prediabetes compared to an enhanced standard care plus wait-list control. Exploratory assessments of implementation facilitators and barriers will also be completed to determine strategies for integrating external diabetes-prevention interventions within healthcare settings.
Read the detailed description
Prediabetes is an increasingly prevalent condition, characterized by glucose levels that are above normal but below the threshold for diabetes. Previous studies have demonstrated that intensive lifestyle interventions targeting changes in diet, physical activity, sleep, and stress can reduce the risk of progressing from prediabetes to Type 2 diabetes. The Diabetes Prevention Recognition Program (DPRP) currently recognizes both in-person and online programs that meet requirements to deliver approved curriculum, provide health coaching and group support, and equip participants with behavioral skills and self-monitoring tools to support behavior change. While non-randomized trial data demonstrate that an online digital program was successful for producing meaningful weight loss and improved glucose control, the goal of this randomized, controlled trial is to definitively evaluate the efficacy of the program for improving weight, glucose control and secondary risk factors compared to current standard care for prediabetes. In addition, few trials have examined the implementation factors that could speed the uptake of efficacious diabetes prevention interventions for delivery in regular clinical practice. Qualitative information on key organizational stakeholders (e.g., physicians, office managers) will be gathered to provide information on perceptions of the online program characteristics, outcomes, and resources concurrently with strategies to promote adoption and implementation in health care settings.
- Conditions
- PreDiabetes
- Being tested
- Online diabetes prevention program, Standard Care
- Keywords
- Prediabetes, Obesity, Intensive behavioral counseling, Type 2 Diabetes
- Medical subject headings
- Prediabetic State, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online diabetes prevention programBehavioural
Digital delivery of 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.
Standard CareBehavioural
One-on-one or small group sessions with a dietitian or a trained health professional to advise on physical activity, healthful nutrition and risk reduction for diabetes.
| 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 in the online program receive paced curriculum, access to a live health coach, interactive group message forums, and connected weight scale and activity monitoring devices. Receives: Behavioral: Online diabetes prevention program |
| Enhanced Standard Care | Active comparator | All participants randomized to the standard-care/control group (SC) will be offered the opportunity to attend a single 90-minute diabetes prevention class with a trained health professional (MPH, RD, or related advanced degree). The class will focus on healthful eating based on the current MyPlate recommendations, guidance on gradual increases in moderate intensity physical activity, and action planning to be shared with friends and/or family. Control participants will also be given the opportunity to participate in the online digital intervention upon completion of the 12-month follow-up assessment. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c reduction
Change in percent HbA1c
Measured: Baseline and 12 months
Secondary outcomes (2)
Weight loss
Reduction in percent of initial body weight
Measured: Baseline, 4 months, and 12 months
Decreased cardiovascular risk
Atherosclerotic Cardiovascular Disease (ASCVD) risk estimator algorithm will be used to assess cardiovascular risk. The tool uses a number of demographic and health characteristics to estimate risk.
Measured: Baseline, 4 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Nov 2017
- Primary completion30 Apr 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated to one of two groups for the duration of the study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omada Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska, Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- Paul Estabrooks, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312764
- Sponsor's protocol ID
- 2017-03-06-001
- Acronym
- PREDICTS
- Status last verified
- Feb 2021
- First submitted
- 6 Oct 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data that underlie the results reported in published manuscripts will be shared.
Publications
Michaud TL, Zagurski C, Wilson KE, Porter GC, Johnson G, Estabrooks PA. Reach and Weight Loss Among Comparison Group Participants Who Enrolled in the Active Intervention After a Diabetes Prevention Trial. Prev Chronic Dis. 2024 Jun 6;21:E40. doi: 10.5888/pcd21.230358.
PubMed 38843118Katula JA, Dressler EV, Kittel CA, Harvin LN, Almeida FA, Wilson KE, Michaud TL, Porter GC, Brito FA, Goessl CL, Jasik CB, Sweet CMC, Schwab R, Estabrooks PA. Effects of a Digital Diabetes Prevention Program: An RCT. Am J Prev Med. 2022 Apr;62(4):567-577. doi: 10.1016/j.amepre.2021.10.023. Epub 2022 Feb 10.
PubMed 35151522
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)
- ClinicalTrials.gov ID
- NCT03312764
- Acronym / sponsor ID
- PREDICTS / 2017-03-06-001
- Conditions
- PreDiabetes
- Keywords
- Prediabetes, Obesity, Intensive behavioral counseling, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Omada Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Nebraska, Wake Forest University Health Sciences
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 18 Oct 2017 (actual)
- 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 randomized controlled trial is to determine the efficacy of a digital diabetes prevention program for improving weight, glucose control, and secondary risk factors among people with prediabetes compared to an enhanced standard care plus wait-list control. Exploratory assessments of implementation facilitators and barriers will also be completed to determine strategies for integrating external diabetes-prevention interventions within healthcare settings.
Detailed description
Prediabetes is an increasingly prevalent condition, characterized by glucose levels that are above normal but below the threshold for diabetes. Previous studies have demonstrated that intensive lifestyle interventions targeting changes in diet, physical activity, sleep, and stress can reduce the risk of progressing from prediabetes to Type 2 diabetes. The Diabetes Prevention Recognition Program (DPRP) currently recognizes both in-person and online programs that meet requirements to deliver approved curriculum, provide health coaching and group support, and equip participants with behavioral skills and self-monitoring tools to support behavior change. While non-randomized trial data demonstrate that an online digital program was successful for producing meaningful weight loss and improved glucose control, the goal of this randomized, controlled trial is to definitively evaluate the efficacy of the program for improving weight, glucose control and secondary risk factors compared to current standard care for prediabetes. In addition, few trials have examined the implementation factors that could speed the uptake of efficacious diabetes prevention interventions for delivery in regular clinical practice. Qualitative information on key organizational stakeholders (e.g., physicians, office managers) will be gathered to provide information on perceptions of the online program characteristics, outcomes, and resources concurrently with strategies to promote adoption and implementation in health care settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated to one of two groups for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Online Diabetes Prevention Program | Experimental | Behavioral: Online diabetes prevention programParticipants will receive access to a 12-month online diabetes prevention program modeled after the CDC DPP curriculum. Participants in the online program receive paced curriculum, access to a live health coach, interactive group message forums, and connected weight scale and activity monitoring devices. |
| Enhanced Standard Care | Active comparator | Behavioral: Standard CareAll participants randomized to the standard-care/control group (SC) will be offered the opportunity to attend a single 90-minute diabetes prevention class with a trained health professional (MPH, RD, or related advanced degree). The class will focus on healthful eating based on the current MyPlate recommendations, guidance on gradual increases in moderate intensity physical activity, and action planning to be shared with friends and/or family. Control participants will also be given the opportunity to participate in the online digital intervention upon completion of the 12-month follow-up assessment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Receives care at University of Nebraska Medical Center or Nebraska Medicine
- Age 19 years or older
- HbA1c 5.7%-6.4%
- Overweight (BMI 25+ or 22+ if Asian)
- Planning to reside in recruitment area for next 12 months
Key exclusion criteria (18 listed)
- Not meeting all inclusion criteria
- Diagnosed with Type I or II diabetes
- Diagnosed with congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, pulmonary hypertension
- Diagnosed with dementia or probable Alzheimer's disease
- Taking oral hypoglycemic agents
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 |
|---|---|---|
| Online diabetes prevention programDigital delivery of 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. | Behavioural | Online Diabetes Prevention Program |
| Standard CareOne-on-one or small group sessions with a dietitian or a trained health professional to advise on physical activity, healthful nutrition and risk reduction for diabetes. | Behavioural | Enhanced Standard Care |
Primary outcome
HbA1c reduction
Time frame: Baseline and 12 months
Change in percent HbA1c
2 secondary outcomes
Weight loss
Time frame: Baseline, 4 months, and 12 months
Decreased cardiovascular risk
Time frame: Baseline, 4 months, and 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 23 Feb 2021.
- Derived from this study: PubMed 38843118Michaud TL, Zagurski C, Wilson KE, Porter GC, Johnson G, Estabrooks PA. Reach and Weight Loss Among Comparison Group Participants Who Enrolled in the Active Intervention After a Diabetes Prevention Trial. Prev Chronic Dis. 2024 Jun 6;21:E40. doi: 10.5888/pcd21.230358.
- Derived from this study: PubMed 35151522Katula JA, Dressler EV, Kittel CA, Harvin LN, Almeida FA, Wilson KE, Michaud TL, Porter GC, Brito FA, Goessl CL, Jasik CB, Sweet CMC, Schwab R, Estabrooks PA. Effects of a Digital Diabetes Prevention Program: An RCT. Am J Prev Med. 2022 Apr;62(4):567-577. doi: 10.1016/j.amepre.2021.10.023. Epub 2022 Feb 10.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data that underlie the results reported in published manuscripts will be shared.
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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.
Paul Estabrooks, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online diabetes prevention program in people with PreDiabetes, run by Omada Health, Inc. at 1 site 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 18 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
HbA1c reduction (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312764, which also lists 2 linked publications.
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 23 Feb 2021.