A pragmatic trial of a family-centered approach to childhood obesity treatment: Rationale and study design.

BACKGROUND: Family-based behavioral treatment (FBT) is an effective intensive health behavior and lifestyle treatment for obesity reduction in children and adolescents, but families have limited access. The purpose of this randomized, pragmatic, comparative effectiveness trial was to examine changes in child relative weight in a 12-month, enhanced standard of care (eSOC) intervention combined with FBT (eSOC+FBT) vs. eSOC alone. METHODS: Children aged 6 to 15 years with obesity, and their primary caregiver, were recruited from primary care clinics. Families were randomized 1:1 to eSOC, a staged approach led by the primary care provider that gradually intensified dependent on a child's response to care and aligns with the American Medical Association guidelines, or the eSOC+FBT arm, which included regular meetings with a health coach for healthy eating, physical activity, positive parenting strategies, and managing social and environmental cues. Both treatments align with the 2023 American Academy of Pediatrics clinical practice guidelines. Assessments occurred at baseline, midpoint (month 6), end-of-intervention (month 12), and follow-up (month 18). Primary outcome was change from baseline to 12 months in child percent overweight (percentage above the median body mass index in the general US population normalized for age and sex). Secondary outcomes were parent weight, child psychosocial factors, heterogeneity of treatment effects, and cardiometabolic risk factors. Exploratory outcomes assessed reach, effectiveness, adoption, implementation, and maintenance. CONCLUSION: This pragmatic trial will generate evidence for the comparative effectiveness of implementing two guidelines-based approaches in primary care for obesity reduction in children and adolescents. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03843424.

Validation of remote child weight and height measurements within a weight management trial.

OBJECTIVE: The aim of this substudy within the Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents, and Providers (TEAM UP) pragmatic clinical trial was to compare the validity of anthropometric measurements collected remotely versus in person (≤7 days apart) among youth with obesity who were 6 to 15 years of age. METHODS: Child (n = 37) weight and height were measured in person by a trained data assessor. These were compared with measurements taken remotely by the child's parent with live videoconferencing observation by a study data assessor. In-person and remote measurements were compared using Bland-Altman plots, Pearson correlations, and two one-sided paired t tests. A priori bounds of acceptability were set at ±0.68 kg to allow for typical weight fluctuations within the 7-day comparison period. RESULTS: Measurements were highly correlated (height: r = 0.991, p < 0.0001; weight: r = 0.999; p = 0.03). For height, two one-sided t tests for upper, t(36) = 3.95, and lower, t(36) = -2.63, bounds (-1, 1) revealed an overall p = 0.006; absolute error was 3.5 cm. For weight, two one-sided t tests for upper, t(36) = 1.93, and lower, t(36) = -7.91, bounds (-0.68, 0.68) revealed an overall p = 0.03; absolute error was 1.7 kg. CONCLUSIONS: The present findings support the utility and interpretation of remotely assessed weight management outcomes for both research and clinical purposes. These procedures may offer greater accessibility to evidence-based measurement.

Assessing the market viability of a packaged intensive health behavior and lifestyle treatment.

In the USA, more than 14 million children are impacted by obesity. Despite intensive health behavior and lifestyle treatments being found effective, gaps exist in moving these interventions into widespread use. Focusing on market viability could improve the dissemination and sustainment of interventions. The purpose of this paper is to outline the process and results of our market viability assessment for the Healthy Weight Clinic (HWC), a Centers for Disease Control and Prevention-recognized Family Health Weight Program. We conducted a market viability assessment using the Speeding Research-test INTerventions (SPRINT) program to gain insights into the commercialization and marketplace for the HWC. Through the process of customer discovery, we interviewed 50 stakeholders to test our hypotheses pertaining to our business model. Key takeaways were the need for packaged interventions that offer support and training for providers, and interventions that are multidisciplinary and located within the medical home. We also learned that (i) the intervention goals must align with the healthcare organization's performance metrics; (ii) services need to be reimbursable; and (iii) the importance of understanding different customer segments (i.e. program users vs. organization decision-makers) and their unique needs. The market viability assessment is a critical step to transforming the HWC into a viable commercial product. The process we have outlined is replicable by others and by encouraging other teams to design for dissemination we can increase the number of evidence-based, packaged IHBLTs available to children with obesity.

In the USA, more than 14 million children are impacted by obesity but few evidence-based interventions are available in the pediatric primary care setting. Focusing on the market viability of evidence-based, intensive health behavior and lifestyle treatments (IHBLT) could improve their dissemination and sustainment. The purpose of this paper is to outline the process and results of our market viability assessment of an intensive health behavior and lifestyle treatment, the Healthy Weight Clinic (HWC), a recognized Centers for Disease Control and Prevention Family Healthy Weight Program. We enrolled in the Speeding Research-test INTerventions (SPRINT) program to understand how to market the HWC by understanding customers' perspectives. Key takeaways include the need for packaged, multidisciplinary interventions in the medical home, ensuring the intervention is reimbursable and aligned with organization's performance metrics, and the importance of knowing customer segments and their needs. This paper addresses the gap pertaining to the market viability of pediatric IHBLT and provides a real-world example of how to conduct an assessment. Additionally, it outlines the process and provides the steps necessary for other researchers to understand the market forces that may impact the viability of their intervention.

Stakeholders' perception of factors influencing adoption of a pediatric weight management intervention: a qualitative study.

Background: Childhood obesity is highly prevalent in the United States and disproportionately impacts communities of color and low-income populations; these disparities have worsened during the COVID-19 pandemic. Adoption of effective pediatric weight management interventions (PWMIs) that have been evaluated among low-income diverse populations is needed. The Healthy Weight Clinic PWMI, a package co-developed by the American Academy of Pediatrics and Massachusetts General Hospital, helps health centers establish multidisciplinary Healthy Weight Clinics based on previous randomized controlled trials which demonstrated effectiveness. We sought to identify the factors influencing successful adoption of this PWMI and understand adaptations needed prior to implementation in new sites. Methods: We interviewed 20 stakeholders, 10 from two health centers in Mississippi where the Healthy Weight Clinic PWMI will be piloted (pre-implementation sites) and 10 from health centers that have previously implemented it (sites in maintenance stages). Separate interview guides informed by the Consolidated Framework for Implementation Research (CFIR) were developed for the pre-implementation sites and those in maintenance stages, including questions related to adaptations of the PWMI in response to the COVID-19 pandemic. Qualitative data analysis was conducted using directed content analysis based on CFIR constructs. Adaptations in response to the pandemic were categorized using Framework for Reporting Adaptations and Modifications-Expanded (FRAME). Results: In pre-implementation sites, an inner setting facilitator mentioned was a positive learning climate. Characteristics of individuals that can facilitate adoption include staff willingness to learn, valuing evidence-based care for childhood obesity, and culturally and weight-sensitive staff. In terms of patient needs and resources (outer setting), social drivers of health are barriers to adoption, but creative solutions were suggested to mitigate these. Other facilitators related to the intervention included its multidisciplinary model and adaptability. Similar themes were elicited from sites in maintenance stages; adaptations brought on by the pandemic, such as telehealth visits and content modification to align with distancing guidelines and the effects of social isolation were also described. Conclusion: Understanding the factors influencing adoption of an evidence-based PWMI informs necessary adaptations and implementation strategies required to facilitate nationwide dissemination of PWMIs, with the goal of reaching the populations most at-risk.

Appraisal of Clinical Care Practices for Child Obesity Treatment. Part II: Comorbidities.

The objective of this technical report is to provide clinicians with actionable evidence-based information upon which to make treatment decisions. In addition, this report will provide an evidence base on which to inform clinical practice guidelines for the management and treatment of overweight and obesity in children and adolescents. To this end, the goal of this report was to identify all relevant studies to answer 2 overarching key questions: (KQ1) "What are effective clinically based treatments for obesity?" and (KQ2) "What is the risk of comorbidities among children with obesity?" See Appendix 1 for the conceptual framework and a priori Key Questions.

Appraisal of Clinical Care Practices for Child Obesity Treatment. Part I: Interventions.

The objective of this technical report is to provide clinicians with evidence-based, actionable information upon which to make assessment and treatment decisions for children and adolescents with obesity. In addition, this report will provide an evidence base to inform clinical practice guidelines for the management and treatment of overweight and obesity in children and adolescents. To this end, the goal of this report was to identify all relevant studies to answer 2 overarching key questions: (KQ1) "What are clinically based, effective treatments for obesity?" and (KQ2) "What is the risk of comorbidities among children with obesity?" See Appendix 1 for the conceptual framework and a priori key questions.

Key Predictors of Primary Care Providers' Self-Efficacy in Caring for Children with Overweight or Obesity.

OBJECTIVE: Self-efficacy is a crucial factor in enabling pediatric primary care providers (PCPs) to deliver recommended care to children with overweight and obesity. This study, conducted with a large, national sample of PCPs, aimed to identify key factors, which may contribute to PCP self-efficacy for obesity-related care, from a list of previously reported barriers and facilitators. METHODS: A national random sample of American Academy of Pediatrics members was surveyed in 2017 (analytic n = 704). Factor analysis was used to identify self-efficacy variables from relevant indicators and assess fit. Multivariable linear regression analyses were conducted to identify key predictors of PCP self-efficacy from reported facilitators or barriers to care, including characteristics of the PCP, practice, community, and payment systems. RESULTS: Two PCP self-efficacy variables were identified: health risk assessment and patient-centered counseling. Both were positively predicted by relevant training, the belief that pediatricians play an important role in obesity, and awareness of barriers to payment for dietitians or weight management programs. Both were negatively predicted by a perceived lack of available PCP time for counseling and inadequacy of available referral resources to assist with treatment. Additional predictors of counseling self-efficacy included PCP beliefs that they are paid for treatment (+) and that patients/families lack time for healthy behaviors (-). Electronic health record clinical decision supports or registries and patient social disadvantage were not predictive. CONCLUSIONS: Results suggest multiple potential roles and strategies for local and national organizations seeking to facilitate improvements to PCP self-efficacy in caring for children with overweight and obesity.

Design and Approach of the Healthy Weight Clinic Pediatric Weight Management Intervention Package and Implementation: Massachusetts-CORD 3.0.

Background: Although proven effective interventions for childhood obesity exist, there remains a substantial gap in the adoption of recommended practices by clinicians. Objective: The aims are to: (1) package implementation and training supports to facilitate the adoption of the evidence-based Healthy Weight Clinic Pediatric Weight Management Intervention (PWMI) (based on three previous effectiveness trials); (2) pilot and evaluate the packaged Healthy Weight Clinic PWMI; and (3) develop a sustainability and dissemination plan. Design/Methods: We used the Consolidated Framework of Implementation Research constructs to create an Implementation Research Logic Model that defined the facilitators and barriers of the Healthy Weight Clinic PWMI. We linked these constructs to implementation strategies and mechanisms. Packaging and design will be informed by the core essential components and functions of the PWMI along with stakeholder engagement. Once the package is complete, we will pilot the PWMI by using a Type III effectiveness-implementation hybrid design. Implementation outcomes will be evaluated by using the RE-AIM framework. Results: We will create an integrated, multisystems level package for national dissemination. The package will include training and a suite of resources for primary care physicians and healthy weight clinic staff, including: patient and caregiver facing videos, patient and caregiver handouts, group curriculum guide, online provider trainings, and access to a virtual learning collaborative. Conclusion: The results will highlight the extent to which the package of the Healthy Weight Clinic PWMI facilitates the adoption of effective strategies for treating childhood obesity. Lessons learned will inform modifications to the Healthy Weight Clinic PWMI and strategies for future scaling.

Planned Evaluation of the Healthy Weight Clinic Pediatric Weight Management and Implementation: Massachusetts-CORD 3.0.

Background: Despite evidence that offering multidisciplinary treatment for children with obesity is effective, access to evidence-based pediatric weight management interventions (PWMIs) is limited. The Healthy Weight Clinic PWMI is a multidisciplinary approach in primary care that improves BMI among children with a BMI ≥ 85th percentile. Objective: To describe the method by which we will evaluate the adoption, acceptability, and feasibility of integrating and implementing a multidisciplinary Healthy Weight Clinic (HWC) into primary care. Design/Methods: We used the Consolidated Framework for Implementation Research (CFIR) domains and constructs to inform our implementation strategies. We will use a Type III hybrid effectiveness-implementation design to test our implementation strategies and improvement in BMI. Sources of data collection will include qualitative interviews with patient caregivers, HWC staff and surveys with HWC staff, patient caregivers, and electronic health record data. Our outcomes are guided by the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. Results: We identified all five CFIR domains as integral for successful implementation. Some strategies to address barriers within these domains include online self-paced training modules for the HWC staff, a virtual learning collaborative, and engagement of site leadership. Outcomes will be measured at the patient and pilot site levels, and they will include patients reached, patient health outcomes such as BMI and quality of life, level of adoption, acceptability, feasibility, and sustainability of the PWMI. Conclusion: Our use of implementation science frameworks in the planning of Healthy Weight Clinic PWMI could create a sustainable and effective program for dissemination.

Perceptions of a Pragmatic Family-Centered Approach to Childhood Obesity Treatment.

Background: Few studies have examined both parent and child preferences regarding family-based weight management programs (WMPs) delivered in primary care settings, especially among racial minority populations. The purpose of this study was to determine the perceptions that parents and their children/adolescents have about the components that should be included in a family-based WMP and to identify perceived preferences, benefits, and/or barriers to participation. Methods: A sample of 60 participants (30 parents and 30 children/adolescents) participated in 1 of 5 separate structured focus groups, using probing questions and the nominal group technique (NGT). Parents reported demographics for themselves and their children/adolescents. Themes from probing questions were identified using thematic analysis. Results: Parents were primarily African American (93%) and diverse in income. NGT sessions revealed that parents across all groups perceived that education on healthy eating, parental involvement, and effective program leaders are most important and have the greatest impact, while parental involvement was perceived as the easiest method to implement in a family-based WMP for childhood obesity. Children/adolescents perceived that education on healthy eating and exercise would have the greatest impact, while healthy eating and meal plans were perceived as the easiest methods to implement with a family. Parents and children/adolescents also identified improved psychological well-being (eg, decreased bullying, increased self-esteem, and motivation) as a desired program outcome. Conclusion: Parents and their children/adolescents highlighted the importance of physical and psychological health as targets in treatment. Feedback from patients can inform the design and implementation of family-based WMPs delivered in primary care settings.

US Pediatrician Practices on Early Nutrition, Feeding, and Growth.

OBJECTIVE: Assess pediatrician practices around growth and nutrition for children under 2 years. DESIGN: 2017 cross-sectional survey of a national random sample of the American Academy of Pediatrics members. SETTING: US. PARTICIPANTS: Practicing primary care pediatricians and residents (n = 698). MAIN OUTCOME MEASURES: World Health Organization growth chart use, solid food introduction recommendations, healthy behaviors discussion. ANALYSIS: Descriptive statistics were calculated for nutrition-related questions. McNemar tests compared recommendations on the introduction of different solid foods at <6 months; chi-square tests of independence examined outcomes by pediatrician and practice characteristics. RESULTS: Most respondents (82.2%) reported using the World Health Organization growth charts at all well visits. Nearly half (45.3%) recommended solid food introduction at 6 months; 48.2% recommended <6 months. Cereals were more frequently recommended at <6 months than fruits/vegetables or meats (P <.001). Topics most frequently discussed were limiting juice (92.3%), and sugar-sweetened beverages (92.0%), avoiding restrictive and permissive food practices (30.7%), and avoiding food as a reward (29.1%) were least discussed. Pediatricians in hospital/clinic settings discussed healthy behaviors less than group or solo/2-physician practices. CONCLUSIONS AND IMPLICATIONS: For children under 2 years, most pediatricians reported using recommended growth charts and discussing healthy behaviors. Fewer discussed responsive feeding topics. Results for guiding solid food introduction were mixed. Continued efforts to support pediatricians' work could improve the implementation of recommended practices.

US Pediatrician Practices and Attitudes Concerning Childhood Obesity: 2006 and 2017.

OBJECTIVE: To compare primary care pediatricians' practices and attitudes regarding obesity assessment, prevention, and treatment in children 2 years and older in 2006 and 2017. STUDY DESIGN: National, random samples of American Academy of Pediatrics members were surveyed in 2006, 2010, and 2017 on practices and attitudes regarding overweight and obesity (analytic n = 655, 592, and 558, respectively). Using logistic regression models (controlling for pediatrician and practice characteristics), we examined survey year with predicted values (PVs), including body mass index (BMI) assessment across 2006, 2010, and 2017 and practices and attitudes in 2006 and 2017. RESULTS: Pediatrician respondents in 2017 were significantly more likely than in 2006 and 2010 to report calculating and plotting BMI at every well-child visit, with 96% of 2017 pediatricians reporting they do this. Compared with 2006, in 2017 pediatricians were more likely to discuss family behaviors related to screen time, sugar-sweetened beverages, and eating meals together, P < .001 for all. There were no observed differences in frequency of discussions on parental role modeling of nutrition and activity-related behaviors, roles in food selection, and frequency of eating fast foods or eating out. Pediatricians in 2017 were more likely to agree BMI adds new information relevant to medical care (PV = 69.8% and 78.1%), they have support staff for screening (PV = 45.3% and 60.5%), and there are effective means of treating obesity (PV = 36.3% and 56.2%), P < .001 for all. CONCLUSIONS: Results from cross-sectional surveys in 2006 and 2017 suggest nationwide, practicing pediatricians have increased discussions with families on several behaviors and their awareness and practices around obesity care.

Improving access and systems of care for evidence-based childhood obesity treatment: Conference key findings and next steps.

OBJECTIVE: To improve systems of care to advance implementation of the U.S. Preventive Services Task Force recommendations for childhood obesity treatment (i.e., clinicians offer/refer children with obesity to intensive, multicomponent behavioral interventions of >25 h over 6 to 12 months to improve weight status) and to expand payment for these services. METHODS: In July 2015, 43 cross-sector stakeholders attended a conference supported by the Agency for Healthcare Research and Quality, American Academy of Pediatrics Institute for Healthy Childhood Weight, and The Obesity Society. Plenary sessions presenting scientific evidence and clinical and payment practices were interspersed with breakout sessions to identify consensus recommendations. RESULTS: Consensus recommendations for childhood obesity treatment included: family-based multicomponent behavioral therapy; integrated care model; and multidisciplinary care team. The use of evidence-based protocols, a well-trained healthcare team, medical oversight, and treatment at or above the minimum dose (e.g., >25 h) are critical components to ensure effective delivery of high-quality care and to achieve clinically meaningful weight loss. Approaches to secure reimbursement for evidence-based obesity treatment within payment models were recommended. CONCLUSIONS: Continued cross-sector collaboration is crucial to ensure a unified approach to increase payment and access for childhood obesity treatment and to scale up training to ensure quality of care.

Are Graduating Pediatric Residents Prepared to Engage in Obesity Prevention and Treatment?

BACKGROUND: Little information is available to gauge residents' perceived receipt of comprehensive training and preparedness to manage children with obesity in practice. METHODS: A national, random sample of 1000 graduating pediatric residents were surveyed in 2013 on childhood overweight/obesity and preparedness to prevent and treat obesity. A composite training measure was created by summing the number of areas (10 possible) where training on overweight/obesity was received. Multivariable logistic regression explored relationships of resident and training characteristics to residents' belief that their own counseling on prevention and treatment of overweight/obesity is very effective (vs somewhat/slightly/not effective). RESULTS: Of 625 survey respondents (63% response), most (68-92%) reported receipt of training in each of 10 assessed areas on overweight/obesity prevention, assessment, and treatment. Most residents did not desire more training in the assessed areas; however, 54% wanted more training in motivational interviewing. About one-fourth believed that their own counseling on the prevention of overweight/obesity (26%) and treatment of obesity (22%) was very effective. Residents who rated their ability to use motivational interviewing as very good/excellent were more likely to rate their counseling on both the prevention and treatment of overweight/obesity as very effective (adjusted odds ratio [aOR] 4.33, 95% confidence interval [CI] 2.63-7.13; and aOR 4.69, 95% CI 2.72-8.07, respectively). Residents who received training in all 10 assessed areas were also more likely to rate their counseling on both prevention and treatment as very effective (aOR 2.58, 95% CI 1.61-4.14; aOR 2.41, 95% CI 1.46-3.97, respectively). CONCLUSIONS: Comprehensive training on overweight/obesity and inclusion of training in motivational interviewing may help residents feel better prepared to care for children with overweight/obesity.

Are Pediatricians "Game"? Reducing Childhood Obesity by Training Clinicians to Use Motivational Interviewing Through Role-Play Simulations with Avatars.

The results of a feasibility study funded by a National Institutes of Health Small Business Innovation Research Phase 1 grant to assess the potential of using online, avatar-based simulation technology to increase pediatricians' use of motivational interviewing techniques to reduce childhood obesity are promising, with potentially positive implications for individual and public health outcomes.