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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Virginia Polytechnic Institute and State University
Sponsor:
Collaborators:
Carilion Clinic
Information provided by (Responsible Party):
Fabio Araujo Almeida, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT02162901
First received: June 11, 2014
Last updated: June 12, 2014
Last verified: June 2014
  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: Open Label
Primary Purpose: Prevention
Official Title: The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs

Resource links provided by NLM:


Further study details as provided by Virginia Polytechnic Institute and State University:

Primary Outcome Measures:
  • Body weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age = or > 18 years
  • BMI = or > 25
  • A score of 5 or higher on the Diabetes Risk Test (American Diabetes Association) NOTE: For African-American and Hispanic women under the age of 40, a score of 3 or higher on the Diabetes Risk Test
  • If available, fasting blood glucose concentration (i.e. IFG) between 100-125 mg/dl within the past 12 months

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02162901

Contacts
Contact: Sarah S Wall, M.Ed. 540-857-6668 sarahsw@vt.edu
Contact: Rochelle A Brown, MPH 540-985-9816 rabrown1@carilionclinic.org

Locations
United States, Virginia
Virginia Tech Translational Obesity Research Center Recruiting
Roanoke, Virginia, United States, 24016
Contact: Sarah S Wall, M.Ed.    540-857-6668    sarahsw@vt.edu   
Contact: Rochelle A Brown, MPH    540-985-8067    rabrown1@carilionclinic.org   
Principal Investigator: Fabio A Almeida, PhD, MSW         
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Carilion Clinic
  More Information

No publications provided

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, 1R18DK091811-01A1
Study First Received: June 11, 2014
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Polytechnic Institute and State University:
Diabetes prevention

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

ClinicalTrials.gov processed this record on August 27, 2014