Denise E. Wilfley - US grants

Binge eating among the overweight is a serious clinical problem. Among overweight individuals seeking treatment, 30% meet the proposed criteria for binge eating disorder (BED). The incidence of binge eating increases with increasing levels of adiposity and is associated with a history of marked weight fluctuations. BED patients experience more eating disorder pathology (e.g., distorted attitudes toward eating, shape, and weight) and general psychopathology (e.g., depression, anxiety) than the non-binge eating obese. To date, most binge eaters have been tread in traditional weight loss programs which do not appear to lead to long-term improvements in binge eating or reductions in-associated eating disorder pathology. Moreover, BED patients may be more likely to drop out of treatment and regain weight faster than non-binge eaters. Given these findings and evidence of similarities between overweight binge eaters and normal-weight patients with bulimia nervosa (BN), we conceptualize binge eating as a serious problem requiring intensive psychological treatment. Few studies have systematically investigated psychological treatments for overweight binge eaters. Recently two treatments adapted from BN to BED that specifically treat the eating disorder have shown promise: group Cognitive-Behavior Therapy (CBT) and group Interpersonal Psychotherapy (IPT). CBT and IPT are derived from different theoretical traditions, assume different etiology for binge eating, and involve entirely different intervention strategies. The work proposed here is designed to compare these treatments and to identify the mechanisms by which they achieve their effects. Over a four year period, 162 overweight men and women who meet criteria for Binge Eating Disorder will be randomly assigned to either group CBT or group IPT. In total, there will be 18 groups with 9 per treatment condition. Treatment will be administered in small groups that meet for 20 weekly sessions. The assessment points will be at: I) baseline; 2) midtreatment; 3) posttreatment; and 4) at 4, 8, and 12 month follow-up assessments. This study will compare two commonly used theories and offer data relevant to the etiology and treatment of binge eating. Additional objectives are to identify the mechanisms by which they achieve their effects and to identify predictors of treatment outcome. Identifying mechanisms will ultimately lead to more efficient and effective treatments whereas identifying predictors of treatment outcome will provide information about the matching of binge eaters to the two treatments: CBT or IPT.

DESCRIPTION (adapted from investigator's abstract): Obesity is a major public health problem. At least 15 million American adults are obese, and the number is rising. Childhood obesity is also increasing in prevalence and currently affects approximately 11-22 percent of children aged 6 to 11. Childhood obesity is associated with serious negative physical, emotional, and social consequences. Obese children are at high risk for becoming obese as adults; 24-44 percent of obese adults were obese as children. The risk of an obese child becoming an obese adult is especially high when at least one parent is obese. To date, adult obesity is known to be resistant to treatment. In contrast, promising long-term effects have been found with children who received behavioral family-based weight loss treatment. However, even with state-of-the-science programs, a substantial percentage of children (i.e., over 40 percent) regain all or most of the weight lost once treatment ends. The proposed study will be the first to examine the efficacy of two strategies designed to improve the long-term maintenance of weight loss in children. Over a 5-year period, 216 obese 9- to 11-year old children who have at least one obese parent will participate, along with the overweight parent, in a 20-week behavioral family-based weight loss treatment. Children will then be stratified by percent overweight change and post-weight-loss level of social problems, and randomly assigned to one of two 4-month maintenance interventions or to a no-continued treatment control. The behavioral skills-based maintenance intervention confronts the declining motivation to engage in weight-maintenance behaviors, incorporates specific skills for weight maintenance, and teaches coping skills and relapse prevention techniques. The social facilitation maintenance treatment uses socially-based approach to enhance peer support, increase parental instrumental support, improve body image, and teach effective responses to teasing as methods of sustaining weight maintenance behaviors (i.e., healthy diet and physical activity). Because the social facilitation maintenance intervention targets the social environment, the investigators posit that it may promote the most natural source of long-term encouragement for energy balance behaviors. The proposed study will examine whether the content of the maintenance sessions or extended treatment is important in improving long-term maintenance. Follow-up assessments will occur at the end of the maintenance phase of treatment, as well as at 12 and 24 months following the initial weight loss treatment. Effective maintenance treatments in children will have a substantial impact on children's immediate and future physical, psychological, and social well being. Improving long-term effects for pediatric obesity is one of the most promising directions in preventing adult obesity.

DESCRIPTION (adapted from investigator's abstract): Obesity is a major public health problem. At least 15 million American adults are obese, and the number is rising. Childhood obesity is also increasing in prevalence and currently affects approximately 11-22 percent of children aged 6 to 11. Childhood obesity is associated with serious negative physical, emotional, and social consequences. Obese children are at high risk for becoming obese as adults; 24-44 percent of obese adults were obese as children. The risk of an obese child becoming an obese adult is especially high when at least one parent is obese. To date, adult obesity is known to be resistant to treatment. In contrast, promising long-term effects have been found with children who received behavioral family-based weight loss treatment. However, even with state-of-the-science programs, a substantial percentage of children (i.e., over 40 percent) regain all or most of the weight lost once treatment ends. The proposed study will be the first to examine the efficacy of two strategies designed to improve the long-term maintenance of weight loss in children. Over a 5-year period, 216 obese 9- to 11-year old children who have at least one obese parent will participate, along with the overweight parent, in a 20-week behavioral family-based weight loss treatment. Children will then be stratified by percent overweight change and post-weight-loss level of social problems, and randomly assigned to one of two 4-month maintenance interventions or to a no-continued treatment control. The behavioral skills-based maintenance intervention confronts the declining motivation to engage in weight-maintenance behaviors, incorporates specific skills for weight maintenance, and teaches coping skills and relapse prevention techniques. The social facilitation maintenance treatment uses socially-based approach to enhance peer support, increase parental instrumental support, improve body image, and teach effective responses to teasing as methods of sustaining weight maintenance behaviors (i.e., healthy diet and physical activity). Because the social facilitation maintenance intervention targets the social environment, the investigators posit that it may promote the most natural source of long-term encouragement for energy balance behaviors. The proposed study will examine whether the content of the maintenance sessions or extended treatment is important in improving long-term maintenance. Follow-up assessments will occur at the end of the maintenance phase of treatment, as well as at 12 and 24 months following the initial weight loss treatment. Effective maintenance treatments in children will have a substantial impact on children's immediate and future physical, psychological, and social well being. Improving long-term effects for pediatric obesity is one of the most promising directions in preventing adult obesity.

Description (provided by applicant): Binge Eating Disorder (BED) is characterized by frequent and persistent episodes of binge eating and associated eating disorder psychopathology as well as general psychiatric comorbidity, psychosocial impairment, and obesity. Although a distinct clinical syndrome, BED is indistinguishable from bulimia nervosa on core eating disorder features such as eating, weight, and shape concerns. To date there is no definitive answer as to what constitutes the most efficacious treatment of BED. Specialty treatments (e.g., interpersonal psychotherapy [IPT]) have demonstrated significant short- and long-term reductions in binge eating and associated psychopathology, but not body weight. Behavioral weight loss (BWL) interventions produce clinically significant short-tem weight loss and reductions in binge eating among obese BED individuals, but the long-term impact on binge eating and other outcomes remains unclear. Guided self-help (GSH) has also demonstrated efficacy for BED in the short-term. The overall aim of this study is to compare the long-term effectiveness of three conceptually and procedurally distinct BED treatments: IPT, BWL, and GSH. A primary question posed is whether BED participants require a specialty treatment (i.e., IM, or whether BWL by itself is sufficient. BWL has the potential advantages of producing weight loss, at least in the short term and being more disseminable as a non-specialty treatment widely administered to obese individuals. Previous tests of BWL for BED have lacked adequate sample sizes, valid measurement of binge eating, and sufficient long-term follow-up. The proposed study remedies these methodological shortcomings, while also evaluating whether IPT or BWL have specific effects beyond that of a credible, minimal treatment (GSH) that is briefer, less costly, and more broadly disseminable than the professionally administered therapies of IPT and BWL. Further, the proposed study tests the differential effectiveness of these BED treatments across levels of negative affect, a dimension along which BED participants reliably subtype. Because IPT targets negative affect, we predict that IPT will prove more effective than either BWL or GSH for the subset of participants with high negative affect. 210 overweight BED participants will be recruited and divided into low negative affect and high negative affect subtypes. Participants will be stratified by negative affect sub-type and randomized to receive one of the three 24-week interventions: IPT, BWL, or GSH. Two treatment sites are required to recruit the large sample needed and to establish generalizability of findings. A third site will serve the function of data coordination and assessment/treatment oversight. Binge eating and associated outcomes will be assessed pre-treatment, post-treatment, and at 6-, 12-, and 24-month follow-up. In addition, likely mediators of change will be assessed during treatment. This study promises to not only clarify the most efficacious overall treatment for individuals with BED, but also to identify sub-groups for whom specific treatments are indicated.

DESCRIPTION (provided by applicant): The public health significance of eating disorders and obesity are well-documented, yet these problems are known to be resistant to treatment. This application is a request for a competitive renewal of an NIMH Midcareer Investigator Award in Patient Oriented Research (K24) in order to relieve Dr. Wilfley from clinical, administrative, and teaching duties, to ensure protected time to: 1) Continue developing and improving efficacious treatments for eating and weight disorders that are informed by advancements in the basic behavioral and biomedical sciences;2) Apply scientific implementation methodology to the deployment of evidence-based treatments for eating and weight disorders into the community;3) Focus on the prevention and early intervention of eating and weight disorders to prevent comorbidity, relapse, and disability;and 4) Engage in teaching and training activities that will help produce the next generation of clinical researchers in the area of eating disorders and obesity. During the present award period, Dr. Wilfley has successfully concluded three NIH-funded R01s, launched two NIH-sponsored awards, and has two more NIH clinical research trials pending. Her studies have identified effective interventions for a subset of women at high risk for developing eating disorders, for the treatment of binge eating disorder, and for childhood obesity. Also, during this time, she has published over 45 peer-reviewed manuscripts, and mentored 17 pre- and post- doctoral students, and junior faculty. Selected ongoing and pending awards include studies designed to test early interventions for adolescents with anorexia nervosa, an enhanced prevention approach for women at very high risk for developing eating disorders, and methods for maintaining weight loss in children over the long-term. This application describes career development goals for Dr. Wilfley to enhance her expertise in the areas of translational research, specifically to bridge the gap from treatment design and refinement to the implementation and deployment of treatments in the community. She plans to enhance her understanding of neuroimaging and psychiatric genetics to facilitate the development of novel strategies for diagnosis, prevention, and treatment of eating and weight related disorders and to augment her mentoring resources. RELEVANCE (See instructions): Given the high morbidity and mortality associated with eating disorders and obesity, a continued refinement of treatment approaches and focus on early intervention and prevention is required. Ensuring that effective treatments are disseminated to the community and reach the patients for whom they are intended is imperative.

[unreadable] DESCRIPTION (provided by applicant): The long-term objective of this proposal is to enhance the treatment and outcome of anorexia nervosa (AN) and to develop a network of research and training centers to support innovative research in AN. Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa, hence it is important to test potentially effective treatments in a large scale study so as to provide a baseline for future studies. The focus of this proposal is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy, (the Maudsley approach) called here, behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Additionally, there is preliminary evidence that fluoxetine may be useful in reducing comorbid psychopathology and enhancing maintenance in AN. However, there has been no placebo controlled study of fluoxetine in adolescent AN. Moreover, although there have been several small-scale studies of BFT there has been no controlled comparison with another form of family therapy. Hence, we propose to use systems family therapy (SFT) which has been developed and manualized to represent the type of family therapy practiced in the community. We propose to randomly allocate 240 adolescents aged 12-18 years with AN and their families to one of 4 groups: BFT + placebo; BFT + fluoxetine; SFT + placebo; and SFT + fluoxetine. Medication will be continued for 6-months beyond the end of family therapy to assess medication effects on the maintenance of therapeutic gains. Treatment and assessment will be carried out at 6 clinical sites with 40 subjects per site with separate data and coordinating centers. The treatment sites will follow common assessment and treatment protocols with detailed monitoring of recruitment, treatment, assessment and human subjects procedures by the coordinating center. The results of this study should provide guidance to clinicians concerning optimal treatment approaches for adolescent AN. From the public health perspective, development of effective treatments for adolescents will reduce the morbidity, mortality, and high costs associated with chronic AN. [unreadable] [unreadable] [unreadable]

[unreadable] DESCRIPTION (provided by applicant): The long-term objective of this proposal is to enhance the treatment and outcome of anorexia nervosa (AN) and to develop a network of research and training centers to support innovative research in AN. Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa, hence it is important to test potentially effective treatments in a large scale study so as to provide a baseline for future studies. The focus of this proposal is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy, (the Maudsley approach) called here, behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Additionally, there is preliminary evidence that fluoxetine may be useful in reducing comorbid psychopathology and enhancing maintenance in AN. However, there has been no placebo controlled study of fluoxetine in adolescent AN. Moreover, although there have been several small-scale studies of BFT there has been no controlled comparison with another form of family therapy. Hence, we propose to use systems family therapy (SFT) which has been developed and manualized to represent the type of family therapy practiced in the community. We propose to randomly allocate 240 adolescents aged 12-18 years with AN and their families to one of 4 groups: BFT + placebo; BFT + fluoxetine; SFT + placebo; and SFT + fluoxetine. Medication will be continued for 6-months beyond the end of family therapy to assess medication effects on the maintenance of therapeutic gains. Treatment and assessment will be carried out at 6 clinical sites with 40 subjects per site with separate data and coordinating centers. The treatment sites will follow common assessment and treatment protocols with detailed monitoring of recruitment, treatment, assessment and human subjects procedures by the coordinating center. The results of this study should provide guidance to clinicians concerning optimal treatment approaches for adolescent AN. From the public health perspective, development of effective treatments for adolescents will reduce the morbidity, mortality, and high costs associated with chronic AN. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): The long-term objective of this proposal is to enhance the treatment and outcome of anorexia nervosa (AN) and to develop a network of research and training centers to support innovative research in AN. Research on the treatment of AN has lagged that of other conditions, even other eating disorders such as bulimia nervosa, hence it is important to test potentially effective treatments in a large scale study so as to provide a baseline for future studies. The focus of this proposal is on adolescent AN. Successful early treatment is likely to reduce the prevalence of chronic AN with its high rates of morbidity and mortality and high health care costs. The most promising treatment for adolescent AN is a specific form of family therapy, (the Maudsley approach) called here, behavioral family therapy (BFT). This treatment is focused on the disordered eating behavior that characterizes AN and enables parents to refeed their child. Additionally, there is preliminary evidence that fluoxetine may be useful in reducing comorbid psychopathology and enhancing maintenance in AN. However, there has been no placebo controlled study of fluoxetine in adolescent AN. Moreover, although there have been several small-scale studies of BFT there has been no controlled comparison with another form of family therapy. Hence, we propose to use systems family therapy (SFT) which has been developed and manualized to represent the type of family therapy practiced in the community. We propose to randomly allocate 240 adolescents aged 12-18 years with AN and their families to one of 4 groups: BFT + placebo;BFT + fluoxetine;SFT + placebo;and SFT + fluoxetine. Medication will be continued for 6-months beyond the end of family therapy to assess medication effects on the maintenance of therapeutic gains. Treatment and assessment will be carried out at 6 clinical sites with 40 subjects per site with separate data and coordinating centers. The treatment sites will follow common assessment and treatment protocols with detailed monitoring of recruitment, treatment, assessment and human subjects procedures by the coordinating center. The results of this study should provide guidance to clinicians concerning optimal treatment approaches for adolescent AN. From the public health perspective, development of effective treatments for adolescents will reduce the morbidity, mortality, and high costs associated with chronic AN.

DESCRIPTION (provided by applicant): The long-range objective of the proposed research is to refine, evaluate, and disseminate an Internet-based intervention to prevent eating disorders (EDs) and comorbidities in college-age women. EDs are highly prevalent among college women and can lead to serious psychological and medical consequences. In previous work, we have shown that an Internet-based intervention can reduce onset of EDs in select subgroups but, given its focus solely on weight/shape concerns (WCS), the intervention had little impact on comorbidities common to this population. We have also identified three risk factors which, when combined with the presence of WCS, indicate very high risk for an ED: a history of depression and/or exposure to critical comments about weight/eating from teachers/coaches/siblings and/or low-level compensatory behaviors (e.g., vomiting and purging). The rate of onset of EDs in women presenting with these risk factors is greater than 30% over 2 years, compared to less than 4% in participants presenting with WCS only. We propose to enhance our previous Internet-based intervention to address these risk factors, and to sustain the effects of the intervention, by including affect improvement and regulation modules, and by adding a maintenance component, respectively. Our primary hypothesis is that, compared to a usual care group, participants in the intervention will have a significantly lower incidence of EDs at two-year follow-up. We expect to lower the incidence from an anticipated rate of 30% to 15%. We also hypothesize that the intervention will significantly reduce WCS, unhealthy weight regulation behaviors (e.g., vomiting, laxative abuse), and dietary restriction while improving mood, coping skills, and emotion regulation. We expect reductions in the combined incidence of depressive, anxiety, and substance use disorders. Moderators and mediators of potential treatment effects will be examined as well. In order to further illustrate our ability to disseminate a low-cost program to universities, we plan to implement and examine the sensitivity and specificity of an Internet-based screen to identify women at risk for EDs and to provide our original prevention program to women with high WCS only. To achieve these aims, 200 college-age women with both high WCS and at least one of the very high risk factors will be randomized to the intervention or a usual care group and followed for at least two years. 250 women with high WCS only and 100 women with low WCS will be recruited for the purpose of screening and dissemination aims. The enhanced intervention, which will be provided for 12 weeks, followed by four maintenance sessions provided over the subsequent eight months, translates findings from basic clinical studies into a disseminable intervention. If effective, the enhanced intervention provides an easy and inexpensive method to reduce EDs and ED comorbidity in college-age women PUBLIC HEALTH RELEVANCE: Eating disorders are common and disabling problems among college-age women. Research has identified a group of college age women at particularly high risk for eating disorders and co-morbid conditions. The purpose of this study is to determine if an internet-based intervention can reduce the onset of eating disorders among this highest risk population and also reduce co-morbidity. If so, this finding, combined with our previous research would have a major public health impact on reducing eating disorder rates.

DESCRIPTION (provided by applicant): The prevalence of childhood overweight (CO) has tripled in recent decades and there is growing recognition of environmental factors related to the rapid increase of this significant public health problem. Socio-ecological models provide a strong theoretical framework for studying the interplay between an individual's weight-related behaviors and his or her environment. Data linking built environments to eating and physical activity habits underscore the potential importance of carefully assessing neighborhood-level variables in weight loss clinical trials. However, few studies have examined whether neighborhood environmental characteristics differentially impact an individual's attempt to modify physical activity and eating behaviors. Spatial databases and Geographic Information System (GIS) technologies provide a means for objectively assessing environmental factors that may moderate weight loss maintenance treatment response. Our present R01 is designed to test the efficacy of an enhanced social facilitation maintenance treatment (SFM+) for overweight children and their families. SFM+ is informed by learning theory and involves lengthening maintenance treatment contact and enhancing treatment focus by targeting a broad range of socio-environmental levels for intervention (individual/self-regulatory skills, family involvement and the home environment, peer relationships and social support, and identification of neighborhood or community resources and barriers to healthy lifestyle behaviors). The objective of SFM+ is to strengthen newly developed weight-regulating skills across socio-environmental contexts over time in order to decrease relapse. Overweight children (N=240) and their parents will complete four months of a family-based behavioral weight loss program and will then be randomized to one of three 8- month maintenance conditions: (1) low dose SFM+ [LOW;16 sessions], (2) high dose SFM+ [HIGH;32 sessions], or (3) a credible health education CONTROL [16 sessions] matched on schedule, duration, and attention of the LOW condition. The LOW and HIGH conditions are matched on content and duration, but differ in treatment dose. We hypothesize that the HIGH condition will produce better weight maintenance and greater improvements in associated outcomes than either the LOW or the CONTROL conditions, and that the LOW condition will produce better weight maintenance than the CONTROL condition. The proposed ancillary study will form a transdisciplinary team of scientists including basic behavioral, public health, and urban design to test the exploratory hypothesis that children's built environment will be a moderator of weight loss maintenance treatment. Because HIGH intensively targets the socio-environmental context, we predict that HIGH will prove more effective than either CONTROL or LOW for the subset of children whose community environments provide limited access to healthful food and opportunities for physical activity. This study promises to not only clarify the most efficacious overall treatment choice for CO, but also to identify subgroups for whom specific treatments are indicated, and to inform public health approaches to the long-term management of CO. PUBLIC HEALTH RELEVANCE: This project seeks to strengthen and expand upon the current R01's aim to identify environmental moderators of pediatric weight loss maintenance. The addition of objective measures of the built environment will provide an important opportunity for transdisciplinary collaboration among public health professionals, urban design investigators, and clinical researchers, as well as add to our understanding of the neighborhood-level characteristics that may influence pediatric obesity treatment response. It is necessary to better understand for whom and under what conditions weight loss is maintained, in order to stem the childhood obesity epidemic and to prevent the tracking of obesity and its negative health and psychosocial consequences into adulthood.

DESCRIPTION (provided by applicant): This is an application for a sixth, five-year period of support for a pre- and postdoctoral training program in Nutrition-Behavioral Cardiovascular Disease Prevention. While the program has continued its prior success with training and launching postdoctoral fellows into independent researchers, the predoctoral training program established in 2002 has met with equally great success. In line with national health priorities such as those of NHLBI, and given that obesity is associated with numerous adverse effects such as hypertension, dyslipidemla, etc., a change in the training program focus to obesity prevention and treatment is proposed. Obesity is a significant public health crisis, and training the next generation of scientists to conduct the translational research necessary to address obesity prevention and treatment across the lifespan is a priority. The program will be led by three international authorities in obesity: Dr. Denise Wilfley (Director) and Drs. Sam Klein and John Newcomer (Associate Directors). The program will continue to be housed within the Departments of Medicine and Psychiatry at the Washington University School of Medicine and the Department of Psychology at Washington University in St. Louis. This trans-disciplinary grant draws mentors from diverse fields (Medicine, Psychiatry, Psychology, Nutrition, Cardiology, Social Work, and Public Health) to train 8 research scholars (4 pre- and 4 postdoctoral). Trainees will develop the translational research skills necessary to treat and prevent problems of weight and eating. Three exciting developments-the recent formation of the Institute of Clinical and Translational Sciences (the result of an NIH Clinical &Translational Science Award), the creation of the Institute of Public Health, and the development of the Center for Obesity Prevention and Policy Research at Washington University-provide additional training resources to conduct this innovative, and much needed, training from "bench to bedside and beyond." Obesity and related diseases are among the University's priority disease areas, and therefore a training program within this institution that focuses on the treatment and prevention of obesity is poised for success and is sure to launch the next generation of scientists prepared to design, implement, and evaluate multi-level solutions to this complex bio-behavioral health problem.

DESCRIPTION (provided by applicant): This proposal is a response to PAR-10-038 Dissemination and Implementation Research in Health. Despite major advances in developing evidence-based psychotherapies, the adoption of such treatments by community therapists has been slow. Hence, it is important to develop and test different methods to effectively train therapists to implement evidence-based psychotherapies in community settings. College campuses have a relatively high prevalence of eating disorders (EDs) and therefore present an efficient environment to test the implementation of strategies to treat these disorders. We propose to train therapists to implement interpersonal psychotherapy (IPT), evidence-based treatments for EDs. Therapists usually learn about new therapies via a workshop and treatment manual. However, it has been shown that this method does not effectively increase therapist skills, nor does it sustain utilization of these interventions. Hence, in this study we will compare two implementation strategies designed to improve upon this approach. The first is a low intensity strategy with the addition of external expert consultation following the workshop. The second is a theoretically-grounded high intensity approach focused on building internal expertise. In this strategy, a staff member from the counseling center will be trained in IPT and coached to train other staff members within the site to implement IPT. This strategy includes quality-control procedures designed to improve implementation and to ensure treatment fidelity. Twenty-six college counseling centers with approximately 230 therapists will be allocated at random to one of the two implementation strategies. Three centers: Washington University (Implementation and Cost Analysis Center), Rutgers University (Fidelity Monitoring Center), and Stanford University (Data Coordinating Center) will conduct the study. The primary aim is to compare therapist fidelity to IPT for the two training strategies and its consequent impact on client outcome. A secondary aim is to examine the generalization of use of IPT for depression. We hypothesize that the high intensity approach will prove significantly more effective than the low intensity strategy, particularly in sustainability. Exploratory moderator and mediator analyses will illuminate the institutional and therapist variables that affect implementation and client outcomes. Because the two approaches differ in resources, the implementation and service costs for each of the training methods will be determined. Implementation will proceed over a twenty month period with a 12-month follow-up to test sustainability, during which period consultation from Washington University will have ceased. This project continues a long-standing collaboration among the three PIs and centers that have focused in the past on understanding factors underlying eating disorders and on the development of evidence- based psychotherapies. To extend our expertise on implementation theory and procedures, we have established collaborations with faculty from the Dissemination and Implementation Core at Washington University, including Drs. Proctor and Raghavan who are co-investigators on this project.

DESCRIPTION (provided by applicant): Eating disorders (EDs) are severe mental disorders associated with high morbidity and mortality, affecting an estimated 13.5% and 3.6% of US college-age women and men, respectively. Colleges are faced with an elevated prevalence of EDs, yet less than 20% of students report receiving treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for improved modalities for screening and intervention. Online interventions have been used to treat and prevent EDs with high user acceptability given their accessible and anonymous format. However, an online platform through which screening and tailored interventions are provided to individuals with EDs has not been deployed. Such a platform can be readily disseminated and easily adopted by organizations for independent use, reducing burden for mental health services while increasing access to care. Over the past 20 years, our team's programmatic line of research has resulted in a comprehensive, online platform through which we identify and offer tailored evidence-based interventions to individuals across the ED risk and diagnostic spectrum, using minimal person-based resources. The newest intervention in our suite of programs, Student Bodies-Eating Disorders (SB-ED), has not yet been tested in a large-scale trial or via platform delivery. The aim of this study is to conduct the first national deployment of our comprehensive platform and demonstrate that our transdiagnostic guided self-help program, SB-ED, yields measurable and significant improvements in access, costs, and outcomes for ED treatment over referral to usual care (i.e., treatment per protocol at students' corresponding college's mental health services center). Technological enhancements include mobile technology and clinical management tools. Twenty-six colleges will be randomly assigned to receive either SB-ED or referral to usual care. We will enroll at least 650 students from these campuses who screen positive for a DSM-5 clinical or subclinical ED (excluding anorexia nervosa, which warrants more intensive medical monitoring). Consistent with a stepped care approach, students who do not report clinically- significant improvements in ED symptoms mid- and post-intervention will be offered an on-campus referral. We hypothesize that SB-ED, as compared to referral to usual care, will produce significant improvements in treatment access (receipt of ED treatment), costs (positive net-benefit from a health care payor's perspective), and outcomes (decrease in ED pathology and functional impairment). We have assembled an expert team of leaders in behavioral science, technology, college health systems of care, and economics to achieve these aims. If successful, our model extends current recommendations for ED treatments to offer an innovative solution to challenges faced by mental health care delivery. Screening and intervention for other mental illnesses can be incorporated, with the goal of scale-up for national dissemination across all 50 states, with the potential to reach the 20 million students enrolled in US colleges and universities.

DESCRIPTION (provided by applicant): Family-based treatment (FBT) is a behavioral weight control intervention that targets children who are overweight/obese and their parents, and has the capacity to improve the weight status of non-targeted family members such as siblings. FBT has significant positive effects on body weight in children for up to 10-years of follow-up, and a robust relationship is observed between child and parent outcomes. FBT's concurrent care of two generations of obesity in the family is more efficacious and cost-effective than if family members are treated by their separate health care providers. Despite its recognized efficacy, FBT is mainly available in specialty clinics and many children fail to receive this guideline-based level of treatment, as recommended by the U.S. Preventive Services Task Force. Primary care offers an optimal setting for delivery of FBT by capitalizing on the established relationship between primary care providers and families. Using interventionists co-located within the primary care setting overcomes barriers posed by fragmentation of care, and lack of provider time and training. One of the challenges to integrating childhood obesity treatment into primary care is optimizing limited health care resources. In behavioral weight loss programs, some individuals learn diet, physical activity, and behavior change information quickly, while others learn more slowly. Individuals also differ in their ability to implement treatment recommendations due to individual differences, such as problems with delaying gratification. FBT accommodates these individual differences by using a personalized system of instruction, or a mastery model, in which the content and dose of treatment is calibrated to the needs of the family, ensuring that treatment effort is consistent with need. This multi-site, clinical trial aims to evaluate over a to year period the effectiveness of FBT delivered by a trained interventionist co-located within primary care plus enhanced usual care delivered by the primary care provider (FBT+EUC) compared to enhanced usual care alone (EUC). Participants will be a representative sample of 528 families with a 6-12 year-old child and a parent who are both overweight/obese. Weight changes in approximately 228 siblings who are overweight/obese and between 2-18 years of age will also be studied. This study will test between group differences in child (Primary Specific Aim 1A) and parent (Primary Specific Aim 1B) weight change, as well as weight change in siblings who are overweight/obese (Secondary Aim 1), changes in parent and child delay of gratification, and how changes in delay of gratification are related to parent and child weight changes (Secondary Aim 2), participant level predictors of treatment success (Secondary Aim 3), and how provider attitudes toward evidence-based treatment and perceptions of FBT may relate to their intention to use co- located FBT in their practices in the future (Exploratory Aim 1). Establishing that FBT can be effectively implemented within real world settings is crucial to creating a system by which children and their families who suffer from obesity can be treated in a centralized primary care setting.

? DESCRIPTION (provided by applicant): The complexities of biological, behavioral, social, and environmental risk factors for obesity and cardiovascular disease (CVD) necessitate team science, capable of crossing the boundaries of disciplinary-specific silos to conduct and evaluate research from a transdisciplinary approach to prevent and treat obesity and CVD across the lifespan. Efforts to facilitate greater collaboration among scientists trained across many fields and levels of training are not only valuable but essential to solving such complex problems. Thus, we propose an innovative, transdisciplinary pre- and postdoctoral training program in obesity and CVD at Washington University in St. Louis (WUSTL). WUSTL is a world-class research institution promoting transdisciplinary, translational research through its unique, collegial, scientific environment across campuses and departments. This program will: 1) recruit and train talented transdisciplinary pre- and postdoctoral trainees; 2) provide trainees with collaborative, transdisciplinary mentorship teams; 3) target diversity in the future scientific workforce; and 4) provide training in the ethical and socially responsible conduct of obesity/CVD research. International authorities on obesity, Denise Wilfley, PhD (Director) and Samuel Klein, MD (Co-Director), will lead the program, supported by highly- qualified, primary and co-mentors spanning 15 departments in the biomedical, cognitive and behavioral, and population health sciences. Primary mentors have been extremely successful in training productive scientists; over the last 10 years, 78% and 87% of past pre- and postdoctoral trainees, respectively, are in research careers or training. Of those in research, 67% and 72% have obtained external funding. Our mentors are well funded (93% with NIH funding) and have strong collaborative ties to facilitate the training of 4 pre- and 4 postdoctoral trainees. Combining pre- and postdoctoral trainees from diverse backgrounds (e.g., genetics, molecular cell biology, psychology, social work, public heath, neurosciences) creates a uniquely dynamic training environment. The WUSTL Nutrition Obesity Research Center, Institute of Clinical and Translational Sciences, Institute for Public Health, Diabetic Cardiovascular Disease Center, and Center for Diabetes Translation Research will provide infrastructure and state-of-the-art resources to support trainees' engagement in transformative, translational science. Program evaluations conducted by trainees, program administration and collaborative mentorship teams will ensure trainees achieve short- and long-term indicators of productivity positioning them for success in obtaining academic positions and independent grants. The Diversity Advisory Committee will assist in the recruitment and retention of highly qualified trainees from diverse backgrounds. Not only is our proposed training program innovative in its design, but using a team science approach guided by stellar mentors, our trainees will be prepared to create and contribute to transdisciplinary scientific approaches that are more likely to yield innovative solutions to the complex problems of obesity and CVD than research previously conducted by individual scientists within a single disciplinary field. (End of Abstract)

PROJECT SUMMARY/ABSTRACT The prevalence of mental health problems among college populations has risen steadily in recent decades, with one-third of college students struggling with anxiety, depression, or an eating disorder. Yet, only 20-40% of college students with mental disorders receive treatment. Inadequacies in mental health care delivery result in prolonged illness, disease progression, poorer prognosis, and greater likelihood of relapse, highlighting the need for a new approach for detecting mental health problems and engaging college students in services. We have developed a transdiagnostic, low-cost mobile health targeted prevention and intervention platform that uses population-level screening for engaging college students in tailored services that address common mental health problems. This care delivery system represents an ideal model for service delivery given its use of our promising, evidence-based mobile programs, a transdiagnostic approach that addresses comorbid mental health issues, and personalized screening and intervention to increase service uptake, enhance engagement, and improve outcomes. Further, our service delivery model harnesses the expertise of our team of leaders in behavioral science, college student mental health, technology, and health economics, and bridges our team's work over the past 25 years in successfully implementing a population-based screening program in over 160 colleges and demonstrating the effectiveness of Internet-based programs for targeted prevention and intervention for anxiety, depression, and eating disorders in over 40 colleges. We propose to test the impact of this mobile mental health platform for service delivery in a large-scale trial across 20 colleges. Students who screen positive or at high-risk for clinical anxiety, depression, or eating disorders (excluding anorexia nervosa, for which more intensive medical monitoring is warranted), which account for a substantial proportion of the mental health burden on college campuses, and who are not currently engaged in mental health services (N=7,884; of 146,000 initially screened) will be randomly assigned to: 1) intervention via the mobile mental health platform; or 2) referral to usual care (i.e., campus health or counseling center). We will test whether the mobile mental health platform, compared to usual care, is associated with improved uptake (i.e., individuals beginning treatment) (Aim 1), reduced clinical cases and disorder-specific symptoms (Aims 2a, 2b), and improved quality of life and functioning (Aim 2c). We will also test putative targets/mechanisms, other mediators, predictors, and moderators of improved mental health outcomes (Aim 3) as well as stakeholder- relevant outcomes, including cost-effectiveness and academic performance (Aim 4). Our comprehensive mental health care platform can yield clinical benefit to students, appeal to university stakeholders, minimize barriers to implementation sustainability on campuses, and produce an economic return on investment compared to usual care. This population-level approach to service engagement has the potential to improve mental health outcomes for the 20+ million students enrolled in U.S. colleges and universities.

Project Summary Family-based Behavioral Treatment (FBT) is an evidence-based pediatric weight management intervention (PWMI) that targets both child and parent. More than 30 years of research indicate that FBT reduces children?s percent overweight by almost 20%, with the average parent losing about 20 pounds during treatment. FBT also meets the US Preventive Services Task Force Recommendations as a comprehensive treatment for childhood obesity delivering more than 26 contact hours. The proposed project brings together a multi-sector team of collaborators, with expertise in behavioral science, community-based implementation science, pediatrics, technology, health services, and health economics. This multi-sector team will package and pilot test FBT for the treatment of pediatric obesity in two sites, representing both rural and urban settings, towards the goal of increasing access to this evidence-based, effective treatment among low-income families with children ages 5 to 12. First, training and treatment will be packaged for dissemination in a turn-key, technology- enhanced format (Aim 1). Given the lack of certified health care providers who can deliver FBT--which creates a major treatment barrier for low-income populations--we will develop the first online FBT training platform that includes FBT training materials for interventionists and treatment support materials for families. To inform this digital treatment package, we will incorporate feedback from a broad range of stakeholders, including representatives from local community-based organizations that serve low-income families, health care providers, local provider organizations, and members of the target populations. Once packaged, the intervention will be implemented in two distinct primary care settings (rural and urban; Aim 2). Primary care offers an optimal setting for FBT delivery, as it capitalizes on the established relationship between primary care providers and families. Co-locating interventionists within the primary care setting overcomes fragmentation of care and addresses provider time and referral barriers. Further, this delivery strategy dovetails with Missouri HealthNet Division?s recent state plan amendment which is scheduled to take effect in Missouri in 2019 to cover intensive obesity behavioral counseling and medical nutrition therapy for Medicaid patients, thus setting the stage for scaling FBT implementation across primary care. Implementation outcomes of the packaged intervention will be assessed at the organizational-level (Aim 2A) and patient-level (Aim 2B). Additionally, a scheduled Medicaid reimbursement mechanism will be evaluated as a promising method for sustainability and can serve as a model for other reimbursement mechanisms for private and public payers across the nation. Finally, the packaged treatment will be optimized based on data and feedback from the study, and community partners will be engaged to develop a sustainability and dissemination plan (Aim 3). Establishing that FBT can be implemented in real world settings is crucial to creating a system where children and their families affected by obesity can be effectively treated in centralized primary care settings.

Project Summary Clinical or subclinical eating disorders (EDs) impact 10% of individuals in their lifetime and are marked by significant functional impairment, early mortality, chronicity, and emotional distress. ED symptoms often emerge in adolescence, with peak onset age in the teenage years. Early recognition and treatment of these devastating illnesses are needed to prevent long-term consequences and a chronic course. Most (80%) individuals with EDs, including teens with EDs (TwEDs), do not receive treatment. Due to major barriers to access and to the delivery of treatment for TwEDs, there is a need for a new model of service delivery that can identify and help TwEDs. We have studied ED-related networking on social media and have demonstrated our ability to harness social media, which is used ubiquitously among teens, to identify and efficiently recruit large numbers of TwEDs. At the same time, our team has successfully developed a guided self-help cognitive- behavioral therapy (CBT)-based mobile app, StudentBodies-Eating Disorders (SB-ED), which includes personalized coaching and interactive sessions to address key ED treatment targets and has demonstrated efficacy among college women with EDs. This tool has great potential to be adapted to address the specific needs of TwEDs. In Aim #1 of the proposed study, we will update and adapt SB-ED to create #ByeED for TwEDs by 1) simplifying language and making content relevant to adolescent issues, 2) including a rewards feature to motivate continued app use, 3) including a within-app social networking feature to facilitate group exchanges and coach-led weekly group sessions, and 4) harnessing machine learning to digest users? social networking data within #ByeED to respond to potential recovery setbacks in real-time and tailor coaching interactions. Following a small focus group of TwEDs to assess initial impressions of the app, #ByeED will be piloted among 20 TwEDs recruited from Instagram, garnering feedback via a mixed methods approach on the efficiency, technical effectiveness, and satisfaction with #ByeED. The app will be further refined for a small pilot randomized controlled trial (RCT) in Aim #2, where we will again leverage Instagram for recruitment of TwEDs who are not engaged in treatment. This RCT will approximate the preliminary effectiveness of #ByeED (n=50) versus a control group (encouraging in-person treatment in their communities, n=50) in reducing ED symptoms, improving quality of life, increasing uptake of care, and impacting targets that are associated with outcomes. We will explore within-app predictors of outcomes, potential moderators of treatment effects (e.g., psychiatric comorbidity), and participant perspectives on potential additional parental involvement in #ByeED. Effect size and attrition estimates will aid in the planning of a larger RCT (R01 mechanism) where we will further expand #ByeED (e.g., automated coaching, parental involvement) and test the app on a larger scale to improve its potential to reduce the extraordinary burden of EDs among teens.