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Preventing Diabetes With Digital Health and Coaching (PREDICTS)

Primary Purpose

PreDiabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Online diabetes prevention program

Standard Care

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Prediabetes, Obesity, Intensive behavioral counseling, Type 2 Diabetes

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Online Diabetes Prevention Program

Enhanced Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HbA1c reduction

Change in percent HbA1c

Secondary Outcome Measures

Weight loss

Reduction in percent of initial body weight

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.

Full Information

NCT ID

NCT03312764

First Posted

October 6, 2017

Last Updated

February 22, 2021

Sponsor

Omada Health, Inc.

Collaborators

University of Nebraska, Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03312764

Brief Title

Preventing Diabetes With Digital Health and Coaching

Acronym

PREDICTS

Official Title

Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Omada Health, Inc.

Collaborators

University of Nebraska, Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes

Keywords

Prediabetes, Obesity, Intensive behavioral counseling, Type 2 Diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants are randomly allocated to one of two groups for the duration of the study.

Masking

InvestigatorOutcomes Assessor

Masking Description

All study investigators that collect data or analyze the data are prevented from knowing the interventions assigned to individual participants.

Allocation

Randomized

Enrollment

598 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Online Diabetes Prevention Program

Arm Type

Experimental

Arm Description

Arm Title

Enhanced Standard Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Online diabetes prevention program

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard Care

Intervention Description

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.

Primary Outcome Measure Information:

Title

HbA1c reduction

Description

Change in percent HbA1c

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

Weight loss

Description

Reduction in percent of initial body weight

Time Frame

Baseline, 4 months, and 12 months

Title

Decreased cardiovascular risk

Description

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.

Time Frame

Baseline, 4 months, and 12 months

Other Pre-specified Outcome Measures:

Title

Implementation Context

Description

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: The value and practicality of integrating a new DPP within their facility Barriers to DPP sustainability Contextual readiness for a diabetes prevention initiative Factors that would facilitate implementation Indicators of successful implementation

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Estabrooks, PhD

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-4365

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

35151522

Citation

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.

Results Reference

derived

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Preventing Diabetes With Digital Health and Coaching

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