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 : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|PreDiabetes||Behavioral: Online diabetes prevention program Behavioral: Standard Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|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.|
|Official Title:||Preventing Diabetes With Digital Health and Coaching for Translation and Scalability (PREDICTS)|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||August 31, 2020|
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.
- HbA1c reduction [ Time Frame: Baseline and 12 months ]Change in percent HbA1c
- Weight loss [ Time Frame: Baseline, 4 months, and 12 months ]Reduction in percent of initial body weight
- 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.
- 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:
- 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
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
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-4365|
|Principal Investigator:||Paul Estabrooks, PhD||University of Nebraska|