The Reach and Effectiveness of Technology-enhanced Diabet... | NCT02162901

ID	Type	Description	Link
1R18DK091811-01A1	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
Carilion Clinic	OTHER
University of Nebraska	OTHER

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Choice-Class with IVR Calls	Experimental	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
Choice-DVD with IVR calls	Experimental	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
Random-Class with IVR calls	Experimental	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
Random-DVD with IVR calls	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Choice-Class with IVR Calls	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.

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

Eligibility Module

Name	Affiliation	Role
Fabio A Almeida, PhD, MSW	Virginia Polytechnic Institute and State University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Tech Translational Obesity Research Center		Roanoke	Virginia	24016	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36908422	Derived	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.