The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs

Study Overview
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Brief Summary
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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.

Official Title
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The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs

Conditions
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Diabetes Prevention

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Choice-Class with IVR Calls<br>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<br>* 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.<br>|
| Experimental: Choice-DVD with IVR calls<br>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<br>* 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.<br>|
| Experimental: Random-Class with IVR calls<br>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<br>* 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.<br>|
| Experimental: Random-DVD with IVR calls<br>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<br>* 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.<br>|
| Active Comparator: Random-Class only<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Weight as measured by clinical scale at baseline, and 12 months. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes prevention