Preventing Diabetes With Digital Health and Coaching (PREDICTS)

February 22, 2021 updated by: Omada Health, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

598

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-4365
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Medically stable
  • Able to provide informed consent
  • Willing to accept random assignment to treatment

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Diabetes Prevention Program
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.
Behavioral: Online diabetes prevention program
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.
Active Comparator: Enhanced Standard Care
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.
Behavioral: Standard Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c reduction
Time Frame: Baseline and 12 months
Change in percent HbA1c
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: Baseline, 4 months, and 12 months
Reduction in percent of initial body weight
Baseline, 4 months, and 12 months
Decreased cardiovascular risk
Time Frame: Baseline, 4 months, and 12 months
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.
Baseline, 4 months, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation Context
Time Frame: 12 months

This qualitative assessment will identify the overall implementation climate for a digital DPP. Key informant interviews will be used to elicit stakeholder perceptions, which will be coded for meaning and grouped into categories. The categories will then be integrated to determine possible implementation strategies for this type of program. As such, there is a single assessment that will result in multiple categories. We identified the a priori hypothetical categories, but may find additional categories and may not find perceptions that align with the current categories. This is a single section since these qualitative outcomes may be variable.

Physician, other health professional, and administrator perceptions of:

  1. The value and practicality of integrating a new DPP within their facility
  2. Barriers to DPP sustainability
  3. Contextual readiness for a diabetes prevention initiative
  4. Factors that would facilitate implementation
  5. Indicators of successful implementation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omada Health, Inc.

Collaborators

Wake Forest University Health Sciences
University of Nebraska

Investigators

  • Principal Investigator: Paul Estabrooks, PhD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-03-06-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual de-identified participant data that underlie the results reported in published manuscripts will be shared.

IPD Sharing Time Frame

The data will be made available beginning 12 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators who provide a methodologically sound proposal, and whose proposed use of the data has been approved by the Sponsor of the study will be given access to data. Data will be made available for participant data meta-analyses. Proposals should be directed to research@omadahealth.com. To gain access, requestors will need to sign a data access agreement. For approved proposals, data will be directly sent electronically to the requestor.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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