Bonnie Spring, Ph.D. - US grants

DESCRIPTION (adapted from investigator's abstract): Obesity is a serious health problem that has reached epidemic proportions in the U.S. today. Obese women have 60-120 percent greater risk of death than their leaner counterparts and even mild overweight heightens the risk of morbidity and mortality. Many overweight people attribute their weight management problems to an irresistible urge to consume high-carbohydrate (CHO) snacks when feeling dysphoric. These so-called "carbohydrate (CHO) "cravers" report mood elevation after eating foods rich in CHO. CHO craving garnered programmatic research attention in the 1980s, but methodological and conceptual difficulties led research on the phenomenon to dissipate. Currently, there is disagreement about whether the phenomenon of CHO craving even exists. Despite this, the CHO-craving concept continues to be widely used by obesity researchers and receives tremendous endorsement by the lay public. In reality, the CHO craving construct has yet to be systematically validated. Study 1 will determine whether the phenomenon of CHO preference can be objectively demonstrated and whether, as CHO-cravers claim, self-administering CHO dispels negative moods. Sixty mildly to moderately overweight females who report excessive consumption of high-CHO snacks will be tested in a substance self-administration paradigm. The aim is to see whether they systematically prefer CHO to protein when induced into a dysphoric mood, given a choice between novel taste and calorie-matched beverages, and blinded to information about their nutrient composition. This study will also test whether CHO intake improves the mood and cognitive performance of self-professed CHO cravers, and whether benefits are greater when CHO are chosen and self-administered, rather than experimenter-administered. Study 2 will compare CHO cravers and weight-matched controls on their insulin, tryptophan and leptin responses to the CHO beverage, as well as their familial history of Type II diabetes. Results will indicate whether CHO cravers show an increased family prevalence of diabetes and display evidence of insulin resistance and blunting of the expected rise in the tryptophan ratio and leptin concentration after CHO intake.

DESCRIPTION (adapted from investigator's abstract): Obesity is a serious health problem that has reached epidemic proportions in the U.S. today. Obese women have 60-120 percent greater risk of death than their leaner counterparts and even mild overweight heightens the risk of morbidity and mortality. Many overweight people attribute their weight management problems to an irresistible urge to consume high-carbohydrate (CHO) snacks when feeling dysphoric. These so-called "carbohydrate (CHO) "cravers" report mood elevation after eating foods rich in CHO. CHO craving garnered programmatic research attention in the 1980s, but methodological and conceptual difficulties led research on the phenomenon to dissipate. Currently, there is disagreement about whether the phenomenon of CHO craving even exists. Despite this, the CHO-craving concept continues to be widely used by obesity researchers and receives tremendous endorsement by the lay public. In reality, the CHO craving construct has yet to be systematically validated. Study 1 will determine whether the phenomenon of CHO preference can be objectively demonstrated and whether, as CHO-cravers claim, self-administering CHO dispels negative moods. Sixty mildly to moderately overweight females who report excessive consumption of high-CHO snacks will be tested in a substance self-administration paradigm. The aim is to see whether they systematically prefer CHO to protein when induced into a dysphoric mood, given a choice between novel taste and calorie-matched beverages, and blinded to information about their nutrient composition. This study will also test whether CHO intake improves the mood and cognitive performance of self-professed CHO cravers, and whether benefits are greater when CHO are chosen and self-administered, rather than experimenter-administered. Study 2 will compare CHO cravers and weight-matched controls on their insulin, tryptophan and leptin responses to the CHO beverage, as well as their familial history of Type II diabetes. Results will indicate whether CHO cravers show an increased family prevalence of diabetes and display evidence of insulin resistance and blunting of the expected rise in the tryptophan ratio and leptin concentration after CHO intake.

craving; emotions; overeating; dietary carbohydrates; behavioral medicine; behavioral /social science research tag; human subject; nutrition related tag; clinical research; female;

DESCRIPTION (provided by applicant): High saturated fat diet, low fruit and vegetable (F/V) intake, and sedentary lifestyle characterize a majority of adult Americans, heightening risk for cardiovascular disease and cancers. Improved diet and activity can reduce risk, but the best prescription to promote healthier diet and more active lifestyle simultaneously remains unknown. By comparing 4 groups randomized to perform all combinations of increasing healthy versus decreasing unhealthy eating and activity, this research tests competing hypotheses about how to optimize simultaneous health behavior change. The Familiarity Hypothesis predicts that the most familiar dieting prescription (decrease fat, increase physical activity) will maximize healthy behavior change. The Optimal Substitution Hypothesis, based on Behavioral Economic Theory, predicts that increasing F/V intake while decreasing sedentary behavior will surpass alternatives by maximizing behavioral substitution of healthful for unhealthful eating and activity. The Low Inhibitory Demand Hypothesis, based on Self-Control Theory, predicts that increasing F/V's while increasing physical activity will be most successful because this prescription places fewest demands on self-control resources. Community-dwelling adults (n=200) with inactive lifestyle and suboptimal diet will self-monitor diet, physical activity, and mood via PDAs during: a 2- week baseline, a 3-week prescription period (when payment is contingent upon changing eating and activity simultaneously to targeted standards), and a 4-month maintenance period. Targeted and collateral diet and activity changes will be measured by self-report, accelerometer, and grocery receipts. Bogus pipeline urinary testing will encourage adherence. Laboratory testing will measure behavioral choices, craving, and attentional allocation to restricted foods and activities in a permissive context in order to shed light on behavioral and psychological processes that mediate healthy lifestyle change. Findings will help to fill an important gap in clinical knowledge about how to optimize healthy simultaneous change in diet and activity among adults.

[unreadable] DESCRIPTION (provided by applicant): The long-term objectives of this research are to find effective ways to increase the use and impact of scientifically accurate cancer information delivered through existing resources like the Cancer Information Service (CIS). Using formative and experimental research methodologies, the proposed work investigates how to connect the CIS to low-income urban African-American and Hispanic women with abnormal PAP tests. The research examines the utility of engaging health care providers who treat the underserved in using and referring their patients to the CIS. The study also evaluates the impact of accessing CIS services on patients' abnormal PAP test follow-up as well as on the quality of the provider-patient relationship. Initial formative research with patients and providers from two large community clinics that treat the underserved will examine familiarity with and views about the CIS, as well as barriers and facilitators of telephoning the CIS for information about cancer prevention and screening. Community feedback will also be sought on materials planned for inclusion in a randomized controlled trial (RCT). The RCT will randomize approximately 500 women just scheduled for colposcopy at the two clinics to two conditions involving different letters from the provider. Usual Care participants will receive a generic letter reminding them of their follow-up appointment. Intervention participants will receive a targeted letter reminding them of the follow-up appointment, asking them or someone they designate to call the CIS, and suggesting questions to ask. Specific aims are to examine whether a targeted physician mailing can increase calls to the CIS, enhance appropriate medical follow-up, and improve satisfaction with provider-patient communication at the follow-up medical visit. The study has the potential to identify a feasible, effective, sustainable, and culturally sensitive strategy to increase awareness and use of the CIS among an underserved population. The burden of cancer falls most heavily on low income African Americans and Hispanics, who are the study population. This research activates providers who treat the underserved to connect their patients to well- trained cancer information specialists who are accessible by telephone. The study examines the impact on medical follow-up and provider-patient communication. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This application addresses Broad Challenge Area (06) Enabling Technologies and Specific Challenge Topic 06-OD(OBSSR)-101*, "Using new technologies to improve adherence" The Diabetes Prevention Program (DPP) intensive lifestyle intervention is the gold standard weight loss treatment for adults with cardiometabolic risk factors. Despite its efficacy, the DPP has not been widely adopted, because its 16 individual, face-to-face sessions with a specialist are considered too burdensome and expensive to be a sustainable program. Attempts to reduce cost by decreasing session number have yielded greatly diminished weight loss. Behavioral adherence to diet and activity goals declines and weight regain routinely begins once frequent face-to-face meetings cease. The still unmet challenge of DPP implementation is how to reduce treatment intensity without excising the regular social support, accountability, and feedback that are essential to maintain adherence. We hypothesize that it is feasible to implement DPP Intensive Lifestyle Treatment as effectively but twice as efficiently by using hand held technology to preserve feedback, accountability, and regular social support. The smartphone-based technology system to be tested is guided by Carver and Scheier's control systems theory of self-regulation. Initial formative research will upgrade the smartphone with engaging features that motivate participants to use the device to self- monitor and interact with a coach and peer support group. Use of the finalized tool will be compared to usual recording on paper records in a preliminary 2-group randomized controlled trial (RCT) involving 64 obese adults. By enabling peer support, accountability, and feedback on diet, physical activity, and weight loss goals continuously through the 6-month intervention period, the ENGAGED system is expected to enhance (1) behavioral adherence [operationalized by (a) self-monitoring of diet and activity and (b) attainment of diet and activity goals], and (2) weight loss. An enabling technology that integrates specialist and peer support resources to improve treatment adherence could help to curtail the obesity epidemic by increasing the efficiency, feasibility, and reach of effective DPP lifestyle intervention. . Lay Summary Long in-person treatment with a professional is now necessary to maintain the adherence to diet and activity goals that is needed for successful weight loss. The ENGAGED study tests a way to reduce cost by having half as many in-person treatment sessions and using specially designed smart phones that help people engage virtually with a counselor and peers who support behavioral adherence to weight loss.

DESCRIPTION (provided by applicant): Poor quality diet and physical inactivity are the most prevalent, preventable causes of death in the United States. In particular, high saturated fat diet (Fat), low fruit and vegetable intake (FV), low physical activity (PA), and high sedentary leisure screen time (Sed) co-occur and heighten the risks of cardiovascular disease and cancers. The first Make Better Choices (MBC1) experiment contrasted four strategies to promote healthful change across these four risk behaviors. Each intervention targeted two behaviors (one diet, one activity) simultaneously and either increased healthy or decreased unhealthy responding. The intervention targeting increased FV and decreased Sed was most efficacious, yielding unexpectedly sustained improvement in three out of the four risk behaviors (FV, Sed, Fat). The proposed MBC2 trial tests the efficacy of MBC intervention to promote sustained, healthful change in diet and activity at 6 and 12 months, as contrasted with an attention control treatment (stress management) . MBC2 also (a) tests competing hypotheses about the optimal way to add PA without undermining maintenance of FV, Sed, and Fat;and (b) examines mediators and biomarkers of healthy lifestyle change. Community dwelling adults (N=250) with suboptimal diet and inactive lifestyle will be randomized to: 1) Sequential MBC (FV+ Sed-, followed by PA+), 2) Simultaneous MBC (FV+Sed-PA+), or 3) Control (stress management). All will use a smart phone with behavioral decision support tools to self- monitor and transmit data and will be coached by telephone. The Mastery hypothesis, based upon theories of self-regulatory strength and habit, predicts superior healthy change for sequential intervention, mediated by greater habit strength for healthy eating and activity. The Synergy hypothesis, based upon goal systems theory, predicts best outcome from simultaneous intervention, mediated by the establishment of a superordinate healthy lifestyle goal. Results of the MBC2 trial will shed light on mechanisms that underlie healthy change in prevalent risk behaviors. If successful, the trial also will result in an innovative, highly disseminable technology-supported minimal counseling intervention to address the modal American unhealthy diet and sedentary lifestyle. PUBLIC HEALTH RELEVANCE: The average adult has a poor quality diet and sedentary lifestyle, but the best way to produce sustained healthy change remains unknown. Make Better Choices treatment uses handheld technology to help people monitor and transmit information about their eating and activity to a personal coach. The proposed trial tests whether Make Better Choices treatment improves diet and activity more than stress management does and whether it is better to add new lifestyle goals all at once or one after another.

DESCRIPTION (provided by applicant): Obesity is a pervasive public health problem, yet most effective weight loss treatments have been in-person Intensive Lifestyle Interventions (INLIs) that are too costly and burdensome to scale. Recently though, an important comparative effectiveness trial conducted by our consultant, Lawrence Appel demonstrated that a technology-supported weight loss INLI that delivered lessons via the web and coaching via telephone could be as effective as in-person treatment. Those findings suggest that it may be feasible to develop more resource- efficient obesity treatment than was previously believed possible. We propose to apply an innovative methodological framework, the Multiphase Optimization Strategy (MOST) 14, to improve a remotely delivered, technology-supported intensive lifestyle intervention for obesity. Unlike nearly all previous research which treats INLI as a bundled treatment package, MOST implements efficient experimentation on individual intervention components to determine which could be reduced, eliminated, or replaced to improve efficiency. This information then guides assembly of an optimal, comprehensive treatment package that, when combined with a core intervention (CORE), achieves target outcomes with least resource consumption and participant burden. The proposed experiment quantifies the effects of five experimental treatment components on 6 month weight loss among 560 adults. The components are: 1. Number of coaching calls [24 or 12]; 2. Text Message support [yes or no]; 3. Primary Care Provider (PCP) contact [yes or no]; 4. Buddy training [yes or no]; 5. Meal replacements recommended [yes or no]). The five components were selected to foster adherence to obesity treatment by acting upon social cognitive mediators of behavior change that are posited by social-cognitive theory (self-efficacy, self-regulation, supportive accountability, facilitation). Findings will be applied to build a new Opt-IN intervention made up of only active components and implementable for $500 or less. Because such an intervention will be both effective and scalable, it will enjoy greatly increased reach and make significant progress in the fight against obesity.

PROJECT SUMMARY/ABSTRACT This application, the first competing renewal for our T32 program, requests funds to continue to provide multi-disciplinary post-doctoral research training focused on behavioral and psychosocial aspects of cancer prevention and control at the Northwestern University (NU) Feinberg School of Medicine (FSM) and Robert H. Lurie Comprehensive Cancer Center (RHLCCC). The goal of this program is to provide outstanding training for its postdoctoral fellows so that they become successful, independent leaders in cancer research. The program will accomplish this goal by providing each trainee with a mentored research experience in cancer prevention or control. The program?s 24 participating faculty are funded PIs of grants totaling $53 million in direct costs annually, an average of $2.2 million per PI. The group includes 19 PhDs and 5 MDs from 7 departments at Northwestern. All mentors are leading experts in the areas of cancer risk behaviors and screening, measurement and intervention science, patient reported outcomes, or community engagement. By teaching trainees to apply cutting edge measurement and intervention science strategies to the behavioral and psychosocial aspects of cancer prevention and control, we will train a next generation of researchers to reduce cancer risk, address disparities, and improve the lives of community members affected by cancer in a more efficient and more cost-effective fashion. Research experiences will be complemented by a weekly seminar, professional development activities, and the opportunity to enroll in either the MPH, MSCI, MSEB, or HSOR master?s programs. The Program creates an individual development plan (IDP) for each trainee and provides regular oversight by a primary mentor and co-mentor to meet training goals. Trainees also have access to a vast array of educational resources made available by the University for all postdoctoral trainees, including biweekly sessions dedicated to career development, ?survival? skills, and learning to succeed and flourish. The program enrolls three new postdoctoral fellows in each of years 1-4, with balanced representation of fellows in cancer prevention and cancer control. We expect to continue to have a large pool of potential trainees of whom a majority have a research background (PhD in a behavioral or social science, exercise science, or nutrition) and a minority have a clinical background (MD intending to pursue a physician/scientist career). External and Internal Advisory Committees will continue to oversee all aspects of the Program. Ongoing evaluation and feedback from the Advisory Committees will ensure that changes are implemented as needed and that training goals are consistently met. The program meets a pressing need to train a next generation of career investigators who can develop, optimize, and evaluate behavioral and psychosocial assessments and interventions to prevent and control cancer and improve quality of life.

The challenges of the college years are often reflected in student health, including poor health habits, which offer an opportunity for preventive intervention. There are daunting technical, privacy, and practical challenges associated with sensing, integrating, analyzing, and conveying data on physical and mental health. Also, at an institutional level, universities that hope to use technologies to improve student health will need to surmount the obstacle that a lot of institutions have no integration that connects data or services on students' physical health with that on their mental health. This workshop could be the starting point of a coordinated effort to overcome such difficulties.

This is a very timely workshop on engaging the university student health community with computational sciences to provide for new approaches to deal with the physical and behavioral aspects of university student life. The PI and co-PI represent expertise in computing and preventative medicine. The plan for the workshop is thoughtful and generally provides enough time for discussion as well as presentation. The prospective invitee list is comprehensive, and should result is a lively discussion. The conference web site will provide access to the white papers and any additional materials, such as presentation materials or reports from breakout groups.

? DESCRIPTION (provided by applicant): Obesity's high prevalence and costs make it a public health crisis, but current standard of care treatment impedes uptake and depletes resources by taking a one-size-fits-all approach. Guidelines recommend provision of expensive, burdensome treatment components (e.g., counseling, meal replacement) continuously to all consumers regardless of weight loss response. Stepped care that tries less costly evidence-based treatments first, reserving more resource-intensive treatments for suboptimal responders is a logical, equitable population health management strategy. However, stepped care approaches to obesity treatment have not yet incorporated inexpensive, widely available mHealth tools. It is unclear whether conjoint clinical and cost outcomes are better optimized by providing a low cost, low intensity, autonomously controlled mHealth treatment as the initial treatment with risk of nonresponse, or by providing a more costly, traditional obesity treatment with the potential to create a dependency that undermines autonomous motivation. The potential pitfall of beginning with mHealth treatment is that long-term outcome may be poor if nonresponse to initially insufficient treatment allows demoralization to set in. To reduce that risk, we will identify nonresponders earlier than previously has been possible by applying a predictive model derived from our prior mHealth obesity research and will quickly reallocate nonresponders to augmented treatment. We propose to use a novel experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to randomize 400 overweight/obese adults to one of two first line treatments, either (1) an app alone (APP), or (2) the app plus coaching (APP +C). Those who do not respond to the first line treatment (i.e., evidenced by failure to lose weight) will be e-randomized to one of two subsequent augmentation tactics, either: (1) Modestly Step-Up: add another mHealth component (e.g., text messages), or (2) Vigorously Step-Up: add both a mHealth component (e.g., texts) and a more traditional component (e.g., coaching, meal replacement). Responders will continue with the same first line treatment for 12 weeks. Assessments will occur at 3, 6, and 12 months to determine (1) whether mHealth or traditional obesity treatment (coaching) is the optimal first line treatment for overweight/obese adults; and (2) whether the optimal response to weight loss failure is to modestly or vigorously augment the first line treatment. As the first stepped care trial to integrate mHealth tools and implement our predictive model of weight loss failure, SMART will be the most temporally and resource efficient strategy evaluated to date.

ABSTRACT We propose a type 1 hybrid effectiveness-implementation study to test an adapted evidence-based intervention and explore critical implementation issues, including feasibility, acceptability, and costs, that influence scale-up and sustainment. We focus this adaptation, effectiveness, and implementation study on underserved rural residents, a population that maintains extremely high rates of suboptimal diet and sedentary behaviors, placing them at elevated risk for cardiovascular disease, obesity, diabetes, cancer, and other chronic conditions. Within the vulnerable low socioeconomic status population of rural residents, Appalachian Kentuckians experience even worse health outcomes, including among the highest rates of morbidity and mortality in the nation. Such adversity is exacerbated by and associated with inadequate community resources. Increasingly, however, Appalachian residents and other vulnerable populations are gaining access to modalities that may be useful in addressing these health challenges, including internet connectivity and nearly ubiquitous cell phone use. Despite this accelerating technology use, the evidence base on personal technology-associated interventions (mHealth) in a rural, high need population remains sparse. We propose finalizing adaptation and testing an evidence-based multicomponent mHealth intervention, Make Better Choices 2 (MBC2), a behavioral program consisting of personalized health coaching, an app, accelerometer, and financial incentives. In a recent randomized controlled trial among urban adults, MBC2 produced large, sustained diet and physical activity improvements by leveraging effective behavior change techniques, including goal-setting, self-monitoring, accountability, and support. To prepare for the implementation of this successful intervention with a new population marked by extreme health inequities and sparse resources, our team has engaged in extensive foundational efforts based on the Dynamic Adaptation Process framework. These include: (1) completing focus groups and key informant interviews to assess the feasibility and acceptability for rural Appalachian residents to use the MBC2 program; (2) undertaking a comprehensive community inventory to reveal existing and needed resources; (3) engaging stakeholders in community and academic team meetings, including community forums and CAB meetings; and (4) identifying MBC2 programmatic and structural elements in need of adaptation. With this extensive preliminary activity, we now propose a type 1 hybrid effectiveness-implementation trial in which we: (1) finalize adaptation by wireframe and usability testing MBC2 with local Appalachian residents; (2) conduct a RCT to test the effectiveness of the adapted MBC2 compared to an active control arm; and (3) explore implementation outcomes and contextual factors, with a focus on sustainment. This project aspires to demonstrate that systematic adaptation and implementation of an evidence-based intervention can lead to meaningful and sustained behavioral changes, and to prepare for potential scale-up and sustainment of the intervention to maximize its public health impact.

Abstract Poor cancers, lengthy, achieve diet and physical activity (PA) behaviors, the most prevalent risk factors for cardiometabolic diseases and can be treated to prevent disease. However, most diet, PA, and weight loss interventions are costly, and burdensome. Theseinterventions could be more cost-efficient if we could tell when people a sustainable pattern of health behavior change so that treatment could be tapered and then stopped without behavioral relapse. Theories of habit formation might be assumed to address this problem, but they have not proved actionable to guide treatment decisions because they do not specify measurable criteria to reliably detect acquisition of a durable behavior pattern. Hence, we propose to identify behavior patterns that precede and predict maintenance of target-level behavioral improvement that persist after an intervention ends. The measurements needed to tell whether an intervention has durably entrained behavioral improvement are collected as part of diet, PA, and weight loss interventions. Specifically, participants continuously self-monitor their behavior digitally while assessments are relayed back to inform them about progress toward goals. We will analyze self-monitoring measures collected in 6 mHealth trials, conducted over 14 years among over 1,600 participants and more than 147,000 daily observations, to assess when an intervention has durably entrained targeted behaviors, as validated by their reliable persistence post- intervention. We will use location scale modeling to quantify change not only in the absolute level (location) of a behavior but also in its within-person variability (scale). We posit that the induction of durable behavior change requires both improvement in location (increases for healthy behaviors; decreases for unhealthy ones) and decrease in scale (i.e., increased behavioral consistency). Aim 1 will apply existing location scale methods to test the hypothesis that effective interventions will improve the location and reduce the scale of targeted behaviors across all trials. Because existing methods only measure scale at the group level and cannot measure the change in an individual's behavioral consistency that we need to personalize treatment adaptation, Aim 2 will extend location scale methods to enable individual estimation of the rate of change in behavioral consistency. Estimates derived from the new method will be analyzed to learn which parameters of behavior change during intervention are most associated with maintenance post-treatment. Finally, Aim 3 will apply machine learning to estimates from the extended location-scale mixed models to establish ranges and behavioral patterns that predict behavioral maintenance post-treatment. These resultswill inform behaviorinterventionscience and improve treatment efficiency by guiding real-timedecisions about the needed dosage and duration of behavioral treatments.