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.

Comparative Effectiveness of Clinical and Community-Based Approaches to Healthy Weight.

OBJECTIVES: The objective was to evaluate if 2 pediatric weight management interventions delivered to Hispanic, low-income children (one in a health center the other in a Young Men's Christian Association) were effective in reducing BMI. We hypothesized that they would be equally effective. METHODS: A total 407 children aged 6 to 12 years with BMI ≥ 85th percentile receiving care at 2 health centers were randomly assigned to a healthy weight clinic (HWC) at the health center or to a modified Healthy Weight and Your Child (M-HWYC) intervention delivered in Young Men's Christian Associations. A total of 4037 children served as the comparison group. We completed a noninferiority test comparing the M-HWYC with the HWC, which was supported if the bounds of the 90% confidence interval (CI) for the difference in percentage of the 95th percentile (%BMIp95) change did not contain what we considered a minimally clinically important difference, on the basis of previous data (0.87). Then, using linear mixed models, we assessed yearly changes in BMI among intervention participants compared with the comparison sites. RESULTS: The mean difference in %BMIp95 between the M-HWYC and the HWC was 0.75 (90% CI: 0.07 to 1.43), which did not support noninferiority. Compared with the comparison sites, per year, children in the HWC had a -0.23 (95% CI: -0.36 to -0.10) decrease in BMI and a -1.03 (95% CI -1.61 to -0.45) %BMIp95 decrease. There was no BMI effect in the M-HWYC. CONCLUSIONS: We were unable to establish noninferiority of the M-HWYC. The HWC improved BMI, offering an effective treatment of those disproportionately affected.

Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial.

BACKGROUND: Recent studies have demonstrated the effectiveness of family-centered, pediatric weight management programs in reducing childhood obesity. Yet, programs to optimize the care of low-income children with obesity are needed. We sought to examine the comparative effectiveness of two, potentially scalable pediatric weight management programs delivered to low-income children in a clinical or community setting. MATERIALS AND METHODS: The Clinic and Community Approaches to Healthy Weight Trial is a randomized trial in two communities in Massachusetts that serve a large population of low-income children and families. The two-arm trial compares the effects of a pediatric weight management program delivered in the Healthy Weight Clinics of two federally qualified health centers (FQHC) to the Healthy Weight and Your Child programs delivered in two YMCAs. Eligible children are 6 to 12 years old with a body mass index (BMI) ≥ 85th percentile seen in primary care at the two FQHCs. Both programs are one-year in duration and have at least 30 contact hours throughout the year. Measures are collected at baseline, 6 months, and 1 year. The main outcome is 1-year change in BMI (kg/m2) and percent change of the 95th percentile (%BMIp95). CONCLUSION: The Clinic and Community Approaches to Healthy Weight Trial seeks to 1) examine the comparative effects of a clinical and community based intervention in improving childhood obesity, and 2) inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.