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The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs (DiaBEAT-it)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Fabio Araujo Almeida, Virginia Polytechnic Institute and State University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02162901
First Posted: June 13, 2014
Last Update Posted: October 20, 2015
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.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Carilion Clinic
Information provided by (Responsible Party):
Fabio Araujo Almeida, Virginia Polytechnic Institute and State University
  Purpose
The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. The overall aim is consistent with the NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. While evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge. The proposed research project will conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs. Adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the Choice group or the Randomization group. Those patients randomized to the Choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated interactive voice response (IVR) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC). SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures include weight loss, cost, and reach of each program. Secondary outcome measures include physical activity behavior; eating behavior; and process evaluation. It is hypothesized that both the SG/IVR and the DVD/IVR interventions will produce significantly greater amounts of weight loss at 6, 12, and 18 months following program initiation than SC but will not differ from one another. The investigators also hypothesize that the DVD/IVR will have broader reach and may be more cost-effective than SG/IVR or SC.

Condition Intervention
Diabetes Prevention Behavioral: Choice-Class with IVR Calls Behavioral: Random-Class with IVR calls Behavioral: Random-Class only Behavioral: Choice-DVD with IVR calls Behavioral: Random-DVD with IVR calls

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs

Further study details as provided by Fabio Araujo Almeida, Virginia Polytechnic Institute and State University:

Primary Outcome Measures:
  • Body weight [ Time Frame: 12 months ]
    Weight as measured by clinical scale at baseline, and 12 months.


Estimated Enrollment: 600
Study Start Date: March 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Choice-Class with IVR Calls
Participants enrolled in this arm of the study will have chosen to attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months.
Behavioral: Choice-Class with IVR Calls
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone call over a period of 12 months.
Experimental: Choice-DVD with IVR calls
Participants enrolled in this arm of the study will have chosen to watch a DVD at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months
Behavioral: Choice-DVD with IVR calls
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
Experimental: Random-Class with IVR calls
Participants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will attend one 2-hour class to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months
Behavioral: Random-Class with IVR calls
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
Experimental: Random-DVD with IVR calls
Participants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will be given a DVD to watch at home to be introduced to the educational intervention, and will then receive follow-up/support IVR calls for a period of 12 months
Behavioral: Random-DVD with IVR calls
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
Active Comparator: Random-Class only
Participants randomized to this arm of the study will be randomized a second time into one of three groups. Participants in this group will attend one 2-hour class to be introduced to the intervention and will receive a workbook to use at home.
Behavioral: Random-Class only
The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through a printed workbook.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age = or > 18 years
  • BMI = or > 25

Exclusion Criteria:

  • Patient's medical record contains ICD-9 codes for a diagnosis of any type of diabetes, congestive heart failure or coronary artery disease
  • Pregnant or becomes pregnant during trial
  • Contraindication to physical activity or weight loss
  • No access to phone
  • Does not speak or read English
  • Patient has indicated "Do Not Contact" in Carilion patient record
  • Patient is diagnosed with diabetes during the trial
  Contacts and Locations
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): NCT02162901


Locations
United States, Virginia
Virginia Tech Translational Obesity Research Center
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Carilion Clinic
Investigators
Principal Investigator: Fabio A Almeida, PhD, MSW Virginia Polytechnic Institute and State University
  More Information

Responsible Party: Fabio Araujo Almeida, Assistant Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT02162901     History of Changes
Other Study ID Numbers: 1R18DK091811-01A1 ( U.S. NIH Grant/Contract )
First Submitted: June 11, 2014
First Posted: June 13, 2014
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Fabio Araujo Almeida, Virginia Polytechnic Institute and State University:
Diabetes prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases