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A pragmatic family-centered approach to childhood obesity treatment
Investigator (PI): Wilfley, Denise
Performing Organization (PO): (Current): Washington University in St. Louis, School of Medicine, Department of Psychiatry / (314) 286-1700
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2024
Record Source/Award ID: PCORI/PCS-2017C2-7542
Funding: Total Award Amount: $13,974,177
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Description of the problem this project seeks to solve: One in five children and one-third of adults have obesity, placing them at lifelong risk for psychological and health challenges that negatively impact quality of life. However, effective, family-based behavioral treatments for obesity exist. The US Preventive Services Task Force (USPSTF) recommends that clinicians screen children aged 6 years and older for obesity and offer or refer them to a comprehensive behavioral intervention to promote improvement in weight status; the interventions should be at least 26 hours over a period of up to 12 months to improve weight status. Family-based treatment (FBT), a treatment that targets both child and parents and meets the USPSTF recommendations, shows reductions in children's percent overweight of almost 20%, with the average parent losing about 20 pounds during treatment. By contrast, the American Medical Association (AMA) recommends a staged approach to childhood obesity screening and counseling. The staged treatment approach, in our study referred to as enhanced standard of care (eSOC), begins with prevention counseling by the primary care provider (PCP) and includes assessment of weight status, patient/family motivation and readiness to change, promotion of healthy eating and activity habits, and use of health behavior change strategies. Intensification of weight loss interventions increases based upon a child's response to care. Our study is designed to compare two treatment models, eSOC vs. eSOC + FBT (FBT plus medical oversight provided to patients by their primary care provider in accordance with the AMA recommendations), to provide families and PCPs with information on the best intervention approach for the behavioral treatment of childhood obesity. Further, there is a significant gap in the evidence on family-based weight management in primary care settings among diverse populations, and much is still unknown about sex differences in response to obesity treatment for children. Our project addresses this urgent need with a special focus on black children, families insured by Medicaid, and sex differences. Outcomes this project hopes to achieve: The goal of our study is to compare the effectiveness of these two clinical treatment options in order to provide families, providers, and payers with information on the best intervention approach for the behavioral treatment of childhood obesity. The long-term objective is to create rapid uptake of effective interventions for childhood obesity into clinical practice. Our primary aim is to test the effectiveness of a 12-month, family-centered, scalable obesity treatment program delivered in primary care to underserved populations by evaluating changes in weight status compared to the eSOC. Our secondary aims are 1) to determine if patients who receive the eSOC + FBT intervention will have improvements in psychosocial factors (e.g., quality of life, coping with bullying) relative to patients who receive eSOC alone; 2) to examine how effects differ across patient subgroups (whites vs. blacks and girls vs. boys) to inform the tailoring of programs to enhance effectiveness in clinical settings; and 3) to examine improvements in standard clinical and laboratory assessments of cardiometabolic outcomes (i.e., blood pressure, lipids, and HbA1c). Finally, our exploratory aim is to conduct process evaluations to assess RE-AIM domains (i.e., Reach, Effectiveness, Adoption, Implementation, Maintenance) of the interventions across patients, providers, and practices, which will inform how to best deliver eSOC and FBT as part of routine clinical practice. Why this project is important to patients and families: Families who have children with obesity struggle to decide how to choose a treatment that is right for them. Parents must weigh the benefits and drawbacks of pursuing a staged approach to services in the primary care setting versus immediately partaking in more intensive services typically found outside the primary care office. Parents may question the value of participating in comprehensive, behavioral interventions when the amount of time and effort required is greater than expected. To address these concerns, this project will colocate a trained behavioral counselor for family-based obesity treatment in the primary care setting. Further, the intervention improves weight outcomes not only in children but also in parents and imparts skills to address many of the other challenges to good mental and physical health faced by families. As such, parents may be more motivated for their children to participate. Addressing this decisional uncertainty (i.e., staged approach vs. immediately partaking in more intensive services) is the foundation of our proposed project and is consistent with Patient-Centered Outcomes Research Institute's (PCORI) mission to improve health care delivery and outcomes by helping families make informed decisions on effective obesity treatment options. How patients and other stakeholder partners will help make this project successful: During the planning phase, we will use rigorous stakeholder-driven processes that emphasize patient engagement to develop our formal study protocol. The Family Advisory Board and Evidence-Based Practice Advisory Board will be tasked with reviewing, critiquing, and providing input on the study protocol and intervention curricula; adding additional family-centered outcomes; and providing ideas for recruitment, retention, and dissemination strategies. The Provider Advisory Board, representing physicians, other primary care providers, and behavioral counselors, will review and inform the eSOC and FBT provider training. The Payer Advisory Board will define questions to answer during the study to guide a strong dissemination plan if the study is successful. We will facilitate parent and child focus groups to fine tune components of the eSOC and FBT curriculum and materials. The PCORI-funded Research Action for Health Network (REACHnet) will also convene parent and child groups to solicit feedback on the manual of procedures, protocols, and assessment instruments. During the active trial, our Family Advisory Board will advise on intervention adaptations and recruitment and retention strategies. Our Evidence-Based Advisory Board will advise on study design challenges, such as evidence-based strategies to increase recruitment and retention. Our Provider Advisory Board will support the Provider Engagement and Training Core as challenges arise related to training PCPs on the eSOC and assuring behavioral counselor fidelity to the FBT delivery. The Payer Advisory Board will provide ongoing support to identify reimbursement mechanisms for the coverage of obesity counseling services to facilitate broader dissemination and implementation of evidence-based care during and after the study. Finally, each advisory board will be involved with the interpretation of findings and development of dissemination strategies for the end-user stakeholders they represent. REACHnet will provide consultation to develop appropriate messaging, agendas, deliverables, and dissemination materials for stakeholders. Conclusion: Pediatric obesity is a serious and growing health problem that threatens both current and future health outcomes. In order to reverse this trend, early identification and intervention is needed. This study will provide the information that patients, providers, and payers need to decrease decisional uncertainty regarding the most effective treatment approach to childhood obesity.
MeSH Terms:
  • Advisory Committees
  • American Medical Association
  • Body Weight
  • Child
  • Decision Making
  • Evidence-Based Medicine
  • Feeding Behavior
  • Health Behavior
  • Humans
  • Patient-Centered Care /*organization & administration
  • Pediatric Obesity /*therapy
  • Pediatrics /methods
  • /*standards
  • Preventive Medicine /methods
  • Primary Health Care /methods
  • Quality of Life
  • United States
Country: United States
State: Missouri
Zip Code: 63110
UI: 20191542
Project Status: Ongoing