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Trial record 1 of 2 for:    omada health
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Preventing Diabetes With Digital Health and Coaching (PREDICTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03312764
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : July 22, 2019
Sponsor:
Collaborators:
University of Nebraska
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Omada Health, Inc.

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.

Condition or disease Intervention/treatment Phase
PreDiabetes Behavioral: Online diabetes prevention program Behavioral: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly allocated to one of two groups for the duration of the study.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: All study investigators that collect data or analyze the data are prevented from knowing the interventions assigned to individual participants.
Primary Purpose: Prevention
Official Title: Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




Primary Outcome Measures :
  1. HbA1c reduction [ Time Frame: Baseline and 12 months ]
    Change in percent HbA1c


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: Baseline, 4 months, and 12 months ]
    Reduction in percent of initial body weight

  2. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312764


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-4365
Sponsors and Collaborators
Omada Health, Inc.
University of Nebraska
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Paul Estabrooks, PhD University of Nebraska

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Responsible Party: Omada Health, Inc.
ClinicalTrials.gov Identifier: NCT03312764    
Other Study ID Numbers: 2017-03-06-001
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD plan.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omada Health, Inc.:
Prediabetes
Obesity
Intensive behavioral counseling
Type 2 Diabetes
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia