Corrine I. Voils, Ph.D. - US grants

DESCRIPTION (provided by applicant): Medication non-adherence is a significant clinical problem in the management of hypertension, with rates ranging from 30-80% and an average of 50%. There is no 'gold standard'for measuring non-adherence. Self- reports are advantageous because they can be administered in any setting, take little time to complete, can provide immediate feedback at the point of care, cost little to administer and analyze, and can detect the specific reasons for non-adherence, thereby identifying areas for intervention. Nonetheless, self-reports are criticized for yielding low non-adherence rates that are 10-20% lower than rates obtained by other methods. These limitations are due, in part, to measurement issues related to latent variable models that have been largely ignored. The first measurement issue is the conflation of causal and effect indicator models. In an effect indicator model, responses to items on a measure are reflected (influenced) by the underlying latent variable (in this case, adherence). In a causal indicator model, responses to items on a measure give rise to the latent variable. Both types of indicators are important for detecting non-adherence;effect indicators reflect the extent to which patients are nonadherent (e.g., how often doses are missed), whereas causal indicators assess specific reasons for non-adherence (e.g., experiencing side effects). Accordingly, our first specific aim is to use both types of indicators to develop and validate a two-step method for assessing medication non-adherence. The first, brief questionnaire will assess the presence and extent of non-adherence. The second, longer questionnaire will assess the reasons for non-adherence. In Study 1, the measures will be administered twice, 3 to 5 days apart, to 200 patients with a diagnosis of hypertension (HTN) taking at least one blood pressure (BP) medication for at least 3 months. Intraclass correlations will provide evidence of the stability (reliability) of the measures. The association between the newly developed measures and BP and other measures (e.g., pharmacy refills, social desirability) will provide evidence of construct validity. The second measurement issue that has been ignored is that non-adherence is analyzed cross-sectionally, which assumes that it is trait-like (i.e., stable over time). Although some people may take their medications consistently, others may not. Accordingly, the second specific aim is to use longitudinal data analytic methods to determine the extent to which adherence is trait-like versus state-like. In Study 2, the two measures developed in Study 1 will be administered by telephone four times at 2-week intervals to 250 patients with HTN taking at least one BP medication for at least 3 months. Mixture distribution latent state-trait analyses will be conducted to determine the number of latent classes (subgroups) of medication takers, the size of each class, and the probability that each person belongs to each class. Personality variables (e.g., conscientiousness) will be assessed at baseline to determine whether membership in each latent class can be predicted. PUBLIC HEALTH RELEVANCE: Treatment decisions are based on estimates of medication non-adherence. These estimates would be most informative if they included how often doses are missed, reasons for missed doses, and whether missing doses is an occasional or ongoing problem. The goals of the proposed research are to develop new questionnaires to assess these aspects of non-adherence. The new questionnaires will help researchers and clinicians assess medication non-adherence more accurately and meaningfully, leading to improved tailored interventions to decrease medication non-adherence.

? DESCRIPTION (provided by applicant): Two-thirds of the United States population is now classified as obese or overweight. Despite the existence of effective behavioral weight loss interventions, many people do not adhere to them, and even people who lose significant weight regain it in the year following intervention. Novel methods are needed to improve adherence to effective weight loss interventions and promote long-term weight loss maintenance. One promising strategy is reinforcement via financial incentives. Positive reinforcement with variable-ratio schedules has received theoretical and empirical support in various behavioral domains. However, the few studies testing this type of strategy for weight loss have been largely ineffective. A key issue is whether incentives should be provided for process (e.g., dietary self-monitoring) or outcome (weight loss). Incenting dietary self-monitoring and weight loss may be more effective than incenting either alone. In previous studies, patients had to attend in-person sessions to turn in self-monitoring records and be weighed, so self- monitoring and interim weight loss were confounded with attendance. To deliver incentives in real-time for dietary self-monitoring and interim weight loss alone, data collection and processing must be automated. In this study, obese community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. We will develop an innovative information technology (IT) solution that will collate dietary self-monitoring data (inpt by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. The 2 (incentive for self-monitoring: yes vs. no) X 2 (incentive for weight loss: yes vs. no) between-subjects design will allow us to establish feasibility and acceptability of incenting self-monitoring and interim weight loss alone and in conjunction. Specific aims are: (1) Determine feasibility and acceptability of using automated algorithms that analyze dietary self-monitoring and interim weight loss data to provide real- time reinforcement using variable-ratio incentives; (2) Evaluate the effectiveness of various recruitment methods and describe recruitment, intervention adherence, and outcome assessment adherence rates; (3) Estimate cost of delivering the intervention and cost to patients. This project will provide the foundation for a comprehensive effectiveness trial to test the impact of incenting dietary self-monitoring and interim weight loss on short- and longer-term weight outcomes while incentives are delivered and once they are withdrawn. If effective, this approach could reduce the prevalence, adverse outcomes, and costs of obesity for millions of Americans.

Project Summary: The University of Wisconsin (UW) Institute for Clinical and Translational Research (ICTR) Mentored Clinical Scholars Program (KL2) began in 2007 against a rich university background of superb,graduate-level education and training programs relevant to clinical and translational research. Now entering its tenth year, the KL2 program has an enviable record of achievement by its scholars; of 64 individuals trained, 91% remain in academic positions, 63 extramural grants have been received, and 665 papers have been published. This success is built around the dual institutional and ICTR commitment to provide scholars with the training, mentorship, and protected time necessary to develop an independent research career. The challenge of the coming grant cycle is to maintain this record of success and continue to train future leaders in clinical and translational science in the era of interdisciplinary team science. New NIH requirements and the increased complexity of the program led to the appointment of Manish Shah, MD, MPH, and Anna Huttenlocher, MD, as program Co-Directors, over the past year, and multiple PIs for the KL2 grant. With a highly developed and effective strategy in place for scholar selection, KL2 career development programs will focus on provision of competency-based training that is based upon Individualized Career Development Plans (ICDP). Scholars will be offered both didactic and experiential learning experiences with an emphasis on value-added training. Beyond obligatory components, any needed additional training in research skills will be detailed in the ICDP and various scholars can take advantage of elective courses, MS or Certificate programs in Clinical Investigation, as appropriate. The KL2 Career Development Seminar series exposes scholars to topics in leadership, professional development, interpersonal and professional communication skills, and strategies for engaging community stakeholders in research. In addition, the K2R Seminar Series engages scholars in R-series grant writing, including revisions after actual and mock study section critiques. Woven throughout will be a simultaneous commitment to facilitate productive team science and communicate the value of mentor and mentee training as reflected by the introduction to scholars of self-guided learning modules from the Northwestern University COALESCE project and a comprehensive KL2 Mentoring Program based on the National Research Mentoring Network, respectively. Completely novel in the new grant cycle, Research Externships and Field Experiences will be available relevant to clinical and translational research. Finally, ICTR will continue to work with the UW School of Medicine and Public Health to enhance the recruitment pool for diverse scholars at UW by supporting long-range ?pipeline? programs, targeting diverse faculty recruitment, and creating a diversity friendly research environment.

Abstract Obesity is the second leading cause of preventable deaths in the United States. Weight loss, and maintenance of weight loss, improves cardiovascular disease risk factors, physical functioning, and quality of life. Interventions that combine dietary change, physical activity increase, and behavioral strategies are efficacious for short-term weight loss but less so for long-term weight loss. Given that the best predictor of long-term weight loss is initial weight loss, strategies are needed to enhance both initial weight loss and weight loss maintenance. Dietary and physical activity behaviors often are influenced by domestic partners. Therefore, intervening jointly on patients and their partners is likely to improve the efficacy of weight management programs. This study involves an evaluation of the role of domestic partner support in a comprehensive weight loss initiation and maintenance program. Eligibility criteria include age 18-75, BMI ?27 kg/m2 with an obesity- related comorbidity or BMI ?30 kg/m2, and cohabitating with a domestic partner. 230 couples will be randomized to 18-month comprehensive weight program directed at patients alone or involving their partners. In months 1-6, all patients will receive group-based weight loss program featuring a calorie-restricted diet and physical activity. In months 7-18, all patients will receive a weight loss maintenance intervention that involves maintenance-specific content, transitions to individual telephone calls, and gradually decreases in frequency of contact. In the partner-assisted arm, partners will learn and practice communication skills and support strategies to facilitate patient health behavior change. Partners will attend patient group sessions, be informed of patients' goals (during initiation) and relapse plans (during maintenance), and receive reinforcing text messages. In months 19-24, intervention will be withdrawn to examine sustainability of effects. Our primary hypothesis is that average 24-month weight in the partner-assisted intervention will be at least 2.5 kg lower than in the patient-only intervention. Secondary outcomes include caloric intake and physical activity at 24 months. Mediation analyses will examine the role of interdependence theory constructs and social support. If successful, this approach could inform refinement and implementation of effective obesity treatments.

ABSTRACT In the past 40 years, the prevalence of obesity has increased at an alarming rate. Even modest weight loss of at least 5% improves clinical parameters and quality of life. Efficacious behavioral weight loss programs teach participants behavioral strategies to create and maintain a caloric deficit. The two strongest predictors of long- term weight loss in such programs are initial weight loss and dietary self-monitoring. Over time, these phenomena decline, limiting program effectiveness. Financial incentives to increase initial weight loss and self- monitoring are appealing because they can be delivered to large populations with relative ease and at low cost. Employers and payers have begun to provide financial incentives for health behaviors and outcomes despite an inadequate evidence base to inform the optimal design of such interventions. The proposed study will evaluate which incentive approach has the greatest impact and durability?incentivizing interim weight loss, dietary self-monitoring, or both. Studies testing the effects of incentivizing these phenomena have showed some promise for increasing short-term weight loss. Few studies have evaluated incentive effects on long-term weight loss; examined the mediating role of intrinsic or extrinsic motivation; or calculated program costs or cost-effectiveness of financial incentive interventions. In the proposed two-site, randomized, single-blinded, longitudinal 2x2 factorial study, known as ?Log2Lose,? we address these limitations by evaluating the individual and joint effects of incentivizing, in near real-time, weekly weight loss and dietary self-monitoring on 6-month weight loss and subsequent weight loss maintenance. People with obesity from the communities of Madison, WI and Durham, NC will receive an 18-month intervention comprising: 1. An incentivized weight loss program for 6 months (Phase I), 2. An incentivized weight maintenance program for 6 months (Phase II), and 3. A non- incentivized weight maintenance program for 6 months (Phase III). Participants will be randomized to receive adjunctive incentives for weekly weight loss, dietary self-monitoring, both, or neither. We will measure the proportion of participants achieving clinically significant weight loss of ?5% at 6 (primary endpoint), 12, and 18 months. We will assess whether extrinsic and intrinsic motivation mediate intervention effect; calculate intervention costs; and calculate cost-effectiveness ratios across the four study arms. Our financial incentives intervention was designed to be scalable by using available technology and automating the process of analyzing data to provide incentives in near real-time. The intervention could be paired with various weight loss interventions offered by clinicians or payers, or integrated into a variety of patient and consumer-facing technologies. Completion of this study will contribute to our long-term goal of identifying and implementing efficacious, cost-effective, scalable approaches to reduce the prevalence of obesity and associated health outcomes.