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

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: Diabetes Prevention

Treatments: Behavioral: Choice-DVD with IVR calls; Behavioral: Random-Class with IVR calls; Behavioral: Choice-Class with IVR Calls; Behavioral: Random-DVD with IVR calls; Behavioral: Random-Class only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02162901

1R18DK091811-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 597 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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597 participants in 5 patient groups

Choice-Class with IVR Calls

Experimental group

Description:

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.

Treatment:

Behavioral: Choice-Class with IVR Calls

Choice-DVD with IVR calls

Experimental group

Description:

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

Treatment:

Behavioral: Choice-DVD with IVR calls

Random-Class with IVR calls

Experimental group

Description:

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

Treatment:

Behavioral: Random-Class with IVR calls

Random-DVD with IVR calls

Experimental group

Description:

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

Treatment:

Behavioral: Random-DVD with IVR calls

Random-Class only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Random-Class only