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. We also hypothesize that the DVD/IVR will have broader reach and may be more cost-effective than SG/IVR or SC.
Many researchers have tried to translate intensive lifestyle interventions that can prevent diabetes into practice. Few have documented how much new programs cost or how many people they could reach. We use an innovative research design that will let us test the effectiveness, reach, and costs of different lifestyle diabetes prevention programs that use different levels of interactive technology and face-to-face support. If successful our project will result in diabetes prevention programs that are cost-effective and have broad potential health impact.
|Tao, Zhipeng; Zheng, Louise D; Smith, Cayleen et al. (2018) Estradiol signaling mediates gender difference in visceral adiposity via autophagy. Cell Death Dis 9:309|
|Cheng, Zhiyong; Zheng, Louise; Almeida, Fabio A (2018) Epigenetic reprogramming in metabolic disorders: nutritional factors and beyond. J Nutr Biochem 54:1-10|
|Sun, Yu; You, Wen; Almeida, Fabio et al. (2017) The Effectiveness and Cost of Lifestyle Interventions Including Nutrition Education for Diabetes Prevention: A Systematic Review and Meta-Analysis. J Acad Nutr Diet 117:404-421.e36|
|Zheng, Louise D; Linarelli, Leah E; Brooke, Joseph et al. (2016) Mitochondrial Epigenetic Changes Link to Increased Diabetes Risk and Early-Stage Prediabetes Indicator. Oxid Med Cell Longev 2016:5290638|
|Zheng, Louise D; Linarelli, Leah E; Liu, Longhua et al. (2015) Insulin resistance is associated with epigenetic and genetic regulation of mitochondrial DNA in obese humans. Clin Epigenetics 7:60|
|W Seidel, Richard; Pardo, Kimberlee A; A Estabrooks, Paul et al. (2014) Beginning a patient-centered approach in the design of a diabetes prevention program. Int J Environ Res Public Health 11:2003-13|
|Cheng, Zhiyong; Almeida, Fabio A (2014) Mitochondrial alteration in type 2 diabetes and obesity: an epigenetic link. Cell Cycle 13:890-7|
|Almeida, Fabio A; Pardo, Kimberlee A; Seidel, Richard W et al. (2014) Design and methods of ""diaBEAT-it!"": a hybrid preference/randomized control trial design using the RE-AIM framework. Contemp Clin Trials 38:383-96|