M. Kaye Kramer

Translating the Diabetes Prevention Program: A Comprehensive Model for Prevention Training and Program Delivery

BACKGROUND The Diabetes Prevention Program (DPP) demonstrated that lifestyle intervention reduces risk for type 2 diabetes and the metabolic syndrome. A universal framework for translation of multiple aspects of the DPP intervention, including training, support, and evaluation is needed to enhance treatment fidelity in a variety of settings. PURPOSE This study aims to develop a comprehensive model for diabetes prevention translation using a modified DPP lifestyle intervention. METHODS The DPP lifestyle intervention was adapted to a 12-session group-based program called Group Lifestyle Balance for implementation in the community setting. A model for training and support mirroring that of the DPP was developed for prevention professionals administering the program. The process of training/support and program implementation was evaluated for feasibility and effectiveness using a nonrandomized prospective design in two phases (N=51, Phase 1: 2005-2006; N=42, Phase 2: 2007-2009; data analysis completed 2008-2009). A total of 93 nondiabetic individuals with BMI >or=25 kg/m(2) and the metabolic syndrome or prediabetes participated. Measures were collected at baseline and post-intervention for all and 6 and 12 months post-intervention for Phase 2. RESULTS Significant decreases in weight, waist circumference, and BMI were noted in both phases from baseline. Participants in Phase 2 also demonstrated decreases in total cholesterol, non-HDL cholesterol, and systolic and diastolic blood pressure that were maintained at 12 months. Average combined weight loss for both groups over the course of the 3-month intervention was 7.4 pounds (3.5% relative loss, p<0.001); 23.8% and 52.2% of those who completed the program reached 7% and 5% weight loss, respectively. More than 80% of those achieving 7% weight loss in the Phase-2 group maintained their weight loss at 6 months. CONCLUSIONS A comprehensive diabetes prevention model for training, intervention delivery, and support was shown to be successful and was effective in reducing diabetes and cardiovascular disease risk factors in this group of high-risk individuals.

Adherence to Preventive Medications Predictors and outcomes in the Diabetes Prevention Program

OBJECTIVE—To evaluate barriers to and strategies for medication adherence and predictors of adherence and the primary outcome in the Diabetes Prevention Program (DPP). RESEARCH DESIGN AND METHODS—Within a randomized, controlled primary prevention study for type 2 diabetes, we collected data on study medication adherence, its predictors, and health outcomes in 27 clinical centers across mainland U.S. and Hawaii. Medication arm participants included 2,155 adults with impaired glucose tolerance randomly assigned to either metformin or matched placebo treatment arms. Structured interviews were used to promote medication adherence and to collect data regarding adherence. Adherence was measured by pill count. The primary DPP outcome of type 2 diabetes was assessed by fasting plasma glucose and oral glucose tolerance test. RESULTS—Older age-groups were more adherent than the youngest group (P = 0.01) in the metformin group. The most frequently reported barrier to adherence was “forgetting” (22%). Women reported more adverse effects of metformin (15 vs. 10%, P = 0.002) in the metformin group. Odds of nonadherence increased as participants reported more than one barrier (odds ratio 19.1, P < 0.001). Odds of adherence increased as participants reported multiple strategies to take medication (2.69, P < 0.0001). There was a 38.2% risk reduction for developing diabetes for those adherent to metformin compared with those adherent to placebo (P < 0.0003). CONCLUSIONS—DPP medication adherence results are unique in primary prevention for a chronic disease in a large multiethnic sample. Our finding that adherence was associated with risk reduction for diabetes supports the development of brief interventions in clinical settings where medication adherence is a challenge.

A Community-Based Diabetes Prevention Program Evaluation of the Group Lifestyle Balance Program Delivered by Diabetes Educators

Purpose With growing numbers of people at risk for diabetes and cardiovascular disease, diabetes educators report increasing referrals for intervention in prevention of these conditions. Diabetes educators have expertise in diabetes self-management education; however, they are generally not prepared for delivery of chronic disease primary prevention. The purpose of this project was to determine if individuals at risk for diabetes who participate in an intervention delivered by trained diabetes educators in existing diabetes self-management education community-based programs can reduce risk factors for diabetes and cardiovascular disease. Methods Diabetes educators in 3 outpatient-hospital programs (urban, suburban, and rural) received training and support for implementation of the Group Lifestyle Balance program, an adaptation of the Diabetes Prevention Program lifestyle intervention, from the Diabetes Prevention Support Center of the University of Pittsburgh. Adults with prediabetes and/or the metabolic syndrome were eligible to enroll in the program with physician referral. With use of existing diabetes educator networks, recruitment was completed via on-site physician in-services, informative letters, and e-mail contact as well as participant-directed newspaper advertisement. Results Eighty-one participants enrolled in the study (71 women, 10 men). Mean overall weight loss was 11.3 lb (5.1%, P < .001); in addition, significant decreases were noted in fasting plasma glucose, low-density lipoprotein cholesterol, triglycerides, and blood pressure. Conclusions These results suggest that the Group Lifestyle Balance program delivered by diabetes educators was successful in reducing risk for diabetes and cardiovascular disease in high-risk individuals. Furthermore, diabetes educators, already integrated within the existing health care system, provide yet another resource for delivery of primary prevention programs in the community.

A novel approach to diabetes prevention: Evaluation of the Group Lifestyle Balance program delivered via DVD

This pilot project evaluated the Group Lifestyle Balance program (GLB), an adaptation of the DPP lifestyle intervention, delivered via DVD with remote participant support provided by the University of Pittsburgh Diabetes Prevention Support Center. Results suggest that GLB-DVD with remote support may provide an effective alternative for GLB delivery.

Design of a cluster-randomized controlled trial of a diabetes prevention program within African–American churches: The Fit Body and Soul study

Evidence from varied community settings has shown that the Group Lifestyle Balance (GLB) Program and other adaptations of the Diabetes Prevention Program (DPP) intervention are effective in lowering diabetes risk. Most DPP data originated from studies of pre-diabetic whites, with only sparse evidence of the effect of DPP in African Americans (AAs) in community settings. This paper describes the design, methods, baseline characteristics and cost effective measures, of a single-blinded, cluster-randomized trial of a faith-based adaptation of the GLB program, Fit Body and Soul (FBAS). The major aims are to test efficacy and cost utility of FBAS in twenty AA churches. Randomization occurred at the church level and 604 AA overweight/obese (BMI≥25kg/m(2)) adults with fasting plasma glucose range from normal to pre-diabetic received either FBAS or a health-education comparison program. FBAS is a group-based, multi-level intervention delivered by trained church health advisors (health professionals from within the church), with the goal of ≥7% weight loss, achieved through increasing physical activity, healthy eating and behavior modification. The primary outcome is weight change at 12weeks post intervention. Secondary outcomes include hemoglobin A1C, fasting plasma glucose, waist circumference, blood pressure, physical activity level, quality of life measures, and cost-effectiveness. FBAS is the largest known cohort of AAs enrolled in a faith-based DPP translation. Reliance on health professionals from within the church for program implementation and the cost analysis are unique aspects of this trial. The design provides a model for faith-based DPPs and holds promise for program sustainability and widespread dissemination.

Molecular IDDM epidemiology: international studies

Abstract The WHO DiaMond Molecular Epidemiology Sub-Project is testing the hypothesis that the geographic differences in IDDM incidence reflect population variation in the frequency of IDDM susceptibility genes (i.e., DQA1 and DQB1 alleles with sequences coding for arginine (R) in position 52 of the DQ χ -chain, and an amino acid other than aspartic acid (ND) in position 57 of the DQ β -chain, respectively) using a standardized case-control design. Data from twelve populations which have completed (or have nearly completed) recruitment and HLA molecular analyses are presented. There was an approximate 2-fold increase in the frequencies of DQA1*0301. DQB1*0201 and DQB1*0302 among IDDM cases compared to non-diabetic controls in most populations. Interestingly, DQA1*0301 was more common in low versus moderate-high incidence countries. DQB1*0201 and DQB1*0302 were more prevalent in the moderate-high incidence areas. DQA1*R and DQB1*ND were both consistent markers of IDDM risk, with stronger associations in moderate-high versus low incidence areas. In general, individuals homozygous for both DQA1*R and DQB1*ND had the highest genotype-specific IDDM incidence rates, which approximated risk estimates for first degree relatives in several countries. These data revealed considerable variation in the frequencies of DQB1 and DQA1 alleles across countries, which likely contribute to the global patterns of IDDM incidence.

Diabetes Prevention Program Community Outreach Perspectives on Lifestyle Training and Translation

The gap between what is known from clinical efficacy research and the systematic community translation of diabetes prevention programs is narrowing. During the past 5 years, numerous randomized and nonrandomized dissemination studies have evaluated the modified delivery of structured Diabetes Prevention Program (DPP) interventions in diverse real-world settings. Programs of sufficient dose and duration, implemented with fidelity, have reported weight losses in the range of 4%-7% with associated improvements in cardiometabolic risk factors at 6 and 12 months from baseline. The current article describes some of the experiences and perspectives of a team of University of Pittsburgh researchers as they have engaged in these efforts.

Evaluation of a community Diabetes Prevention Program delivered by diabetes educators in the United States: One-year follow up

Strategies for management of pre-diabetes within the community setting are needed. An adaptation of the successful Diabetes Prevention Program lifestyle intervention delivered by trained diabetes educators was evaluated. Results indicate that trained diabetes educators offer an important community resource for health care providers for their patients with pre-diabetes.

Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial

Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n = 404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health systems services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance(™)). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CAREs cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated-through a new model of accessible and integrative lifestyle medicine and mental health expertise-in primary care.

Adapting the Group Lifestyle Balance™ Program for Weight Management Within a Large Health Care System Diabetes Education Program

Purpose The purpose of this translation study was to evaluate the feasibility and effectiveness of an adapted Group Lifestyle Balance (GLB) intervention for weight management implemented through an existing diabetes education program within a large health care delivery system for overweight/obese individuals with diabetes, prediabetes, or neither condition. Methods Adults with BMI ≥ 25 kg/m2 participated in an adapted GLB intervention designed to be appropriate regardless of diabetes status. Effectiveness was based on changes in weight and minutes of physical activity between baseline and completion of the 12-week core. Differences between subjects based on diabetes status were also examined. Results A total of 111 subjects with diabetes, prediabetes, and no diabetes completed baseline survey data and attended at least 9 of the 12 core sessions from April 2010 through December 2011. All achieved significant weight loss, and the proportion of subjects who reported exercising at least 150 minutes/week increased. Conclusions The adapted GLB intervention for weight management implemented through an existing diabetes education program in a large health care system was feasible and effective in the population, regardless of participants’ diabetes status.