The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs

NCT ID: NCT02162901

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 597 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-13
• Study Completion Date: 2017-04-28

Brief Summary

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.

Conditions

Diabetes Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Choice-Class with IVR Calls

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

Choice-DVD with IVR calls

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

Random-Class with IVR calls

Intervention Type: BEHAVIORAL

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.

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

Group Type: EXPERIMENTAL

Random-DVD with IVR calls

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Random-Class only

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Carilion Clinic

OTHER

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabio A Almeida, PhD, MSW

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Virginia Tech Translational Obesity Research Center

Roanoke, Virginia, United States

Countries

United States

References

Almeida FA, You W, Brito FA, Alves TF, Goessl C, Wall SS, Seidel RW, Davy BM, Greenawald MH, Hill JL, Estabrooks PA. A randomized controlled trial to test the effectiveness of two technology-enhanced diabetes prevention programs in primary care: The DiaBEAT-it study. Front Public Health. 2023 Feb 24;11:1000162. doi: 10.3389/fpubh.2023.1000162. eCollection 2023.

Reference Type: DERIVED

PMID: 36908422 (View on PubMed)

Other Identifiers

1R18DK091811-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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1R18DK091811-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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