Preventing Diabetes With Digital Health and Coaching
PREDICTS
1 other identifier
interventional
598
1 country
1
Brief 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. Exploratory assessments of implementation facilitators and barriers will also be completed to determine strategies for integrating external diabetes-prevention interventions within healthcare 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 Nov 2017
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 6, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedFebruary 23, 2021
February 1, 2021
2.5 years
October 6, 2017
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c reduction
Change in percent HbA1c
Baseline and 12 months
Secondary Outcomes (2)
Weight loss
Baseline, 4 months, and 12 months
Decreased cardiovascular risk
Baseline, 4 months, and 12 months
Other Outcomes (1)
Implementation Context
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 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 COMPARATORAll 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Omada Health, Inc.lead
- University of Nebraskacollaborator
- Wake Forest University Health Sciencescollaborator
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198-4365, United States
Related Publications (1)
Katula 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.
PMID: 35151522DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Estabrooks, PhD
University of Nebraska
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All study investigators that collect data or analyze the data are prevented from knowing the interventions assigned to individual participants.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2017
First Posted
October 18, 2017
Study Start
November 1, 2017
Primary Completion
April 30, 2020
Study Completion
August 31, 2020
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data will be made available beginning 12 months and ending 36 months following article publication.
- 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.
Individual de-identified participant data that underlie the results reported in published manuscripts will be shared.