Our FBCO treatment study was designed and executed within a local community context, taking into consideration the available resources and infrastructure of local health care and community organizations in a health disparate region. Our study setting and sample is distinct from most other published FBCO treatment trials that were typically conducted in urban academic medical centers or large primary care settings and that include samples with higher SES, less ethnic/minority representation, and a higher proportion of married household [74–77]. Our concurrent appraisal of reach, effectiveness, and implementation outcomes of two FBCO interventions within a medically underserved region addresses notable gaps in the scientific literature and helps guide stakeholder decisions pertaining to organizational maintenance of an intervention.
Contrary to our hypotheses, the high intensity iChoose program did not yield significantly greater improvements in child BMI z-scores as compared to the low intensity Family Connections program. Despite exceptionally high implementation fidelity ratings for both iChoose and Family Connections, neither program yielded significant improvements in child BMI z-scores or parent BMI levels. In previously published trials of Bright Bodies [18–20] (from which iChoose was adapted from) and Family Connections [35], BMI z-score reductions were around 0.16 and 0.07 respectively. Our findings highlight the ability to achieve high fidelity when systematically translating FBCO treatment interventions for adoption and implementation by community partners; but also highlight challenges of replicating effects established among urban and relatively affluent communities into a more rural, low SES, and medically underserved community.
Direct evidence on a clinically significant threshold for BMI z-score changes among overweight and obese children is not clearly established. Various reports and expert panels typically suggest BMI z-score reductions at benchmarks of 0.25, 0.20, and 0.15 as clinically significant and as associated with improvements in cardiometablic profile [22, 78]. While other reviews offer differing interpretations of clinically relevant BMI z-score improvements (e.g., 0.12–0.16) [79]. Notably, arresting gain in excess BMI also likely constitutes a clinically important benefit for many children [76, 78, 80]. The clinical significance of achieving weight stabilization may be especially relevant among overweight children (which includes about 1/3 of the children in our study) and among communities that bear unequal burden of childhood obesity, such as the minority and low income families targeted in this trial. Of studies used to inform the USPSTF childhood obesity treatment recommendations, few trials targeted more rural, minority, and low-income communities [22]. Coupled with our null findings in this type of disparate region, it is important to identify similar treatment recommendations to tackle childhood obesity in those areas.
Other trials that have examined childhood obesity treatment effects by programs of varying structure and intensity have been mixed, with some observing better effects for high intensity programs [77] and others observing no differences [74–76]. Our study findings on QOL, proportion of participants with BMI improvements, retention, and engagement suggest that a lower intensity program may better fit the needs of our intended audience. Specifically, Family Connections parents improved QOL, relative to iChoose parents. A greater proportion of Family Connections children and parents experienced 6-month BMI improvements compared to iChoose families. Though this finding is only descriptive and should be interpreted with caution. Also, 6-month retention rates were higher for Family Connection (84%) than for iChoose (63%) families. Finally, engagement in Family Connections components (52–61%) was higher than engagement in iChoose components (25–36%).
Challenges in engaging families in childhood obesity treatment interventions are well documented in the literature [23–29, 81]. Low engagement reduces participant exposure to intended program content. Despite use of a PAT to provide a social network and serve as a safety net to promote family engagement in our CER trial, our engagement remained substantially lower than desired. It is difficult to make strong inferences about how family engagement may have been impacted without a PAT, yet we postulate that engagement may have suffered even more. Compared to our previous single-group 3-month pilot trial of iChoose (n = 101 families, retention = 72%, 43% family class attendance, 62% call completion, 33% physical activity class attendance) in this region [30], we were not any more successful with the addition of a PAT and other deliberate engagement and retention strategies for this trial—suggesting that program features may be stronger predictors of engagement than the social support strategies targeting engagement.
Challenges with program engagement and retention could be linked to our approach that focused on optimizing reach to increase the likelihood that those who could benefit most from a FBCO intervention. In our trial, there were few exclusion criteria, active outreach to a large population of families (i.e., not just families motivated enough to respond to passive recruitment approaches), and strategies to make it as easy as possible for families to enroll. This can be contrasted with published FBCO trials that use run in periods, have strict standards for enrolling families (e.g., must make a full commitment to engage in all intervention components) and for dismissing families who are not engaging (e.g., missed more than two classes) [82]. These procedures may improve receipt of program content among retained families, and subsequently bolster program effectiveness. However, this approach may not be appropriate for low income families nor be reflective of the service model and mission of typical clinical and community partner organizations who are ultimately intended to adopt and sustain a FBCO treatment intervention.
The economic impact of childhood obesity is complex and the heterogeneity of treatment studies and healthcare models makes it difficult to compare and contrast costs across interventions [83]. Regardless, costs of childhood obesity treatment options helps guide decision making among policy makers, program planners, and community organizations who may choose to adopt a FBCO program. Other cost effectiveness analyses of childhood obesity treatment interventions indicate mixed findings [84–87]. One analysis of 10 RCTs demonstrated that it may take six or seven decades to realize cost savings and health benefits of these interventions [85]. While a full cost effectiveness analysis was beyond the scope of this study, capturing organizational-level program implementation costs and costs per participant with improved BMI outcomes from a budgetary impact perspective is an important metric for stakeholders and is rarely reported in other FBCO trials [88]. This metric could be used to compare across studies in the future. We presented actual costs of program implementation in the Dan River Region, which allow other communities to adjust and project potential costs in different scenarios. For this trial, overall program implementation costs for the higher intensity iChoose program was approximately 2–3 times higher than for the lower intensity Family Connections program. This cost data, along with outcome and engagement data, has been shared with our CAB and will be used to inform future FBCO intervention adaptation and adoption.
Our findings inform several potential future directions for this line of FBCO research. First, development of self-regulation skills through more intensive self-monitoring strategies should be revisited both iChoose and Family Connections. In weight-related trials, evidence-based self-monitoring strategies often target diet, exercise and/or self-weighing [89]. Both our FBCO treatment interventions included several self-monitoring strategies (i.e., IVR component to assist with diet and exercise goal setting and feedback, structured self-monitoring activities within classes and take-home activities for families, bi-weekly weigh-ins for iChoose families). Nonetheless, limited improvements in self-reported behavioral outcomes may suggest insufficient emphasis on these strategies. Second, future efforts are needed to explore additional asynchronous, remote and/or technology-based programmatic options. Relative to in-person components, our study showed higher engagement rates for the asynchronous, but proactive IVR components. For lower resourced families, there is an important balance of building face-to-face relationships and support systems versus meeting the needs of these busy families, including many single headed households. Third, engaging clinical providers at the point of care for families is also a promising approach in the FBCO research literature and should be strongly considered in future efforts [75, 90].
When first embarking on this FBCO research over five years ago, our CAB partners helped guide key decisions around self-monitoring strategies (i.e., strong dislike about calorie counting, concerns pertaining to overt focus on weight and regularly weighing children as related to self-esteem and bullying) and program structure (i.e., perceived need for face-to-face contact with families). With local data now available on these two FBCO programs, along with the recent surge of internet connectively and ubiquitous utilization of mobile technology, future efforts should consider more robust remote strategies to deliver childhood obesity treatment intervention content, provide support, and assist with goal setting and self-monitoring. These efforts should be guided by emerging evidence from digital and telehealth approaches in other childhood obesity treatment trials [76, 91–93]. Likewise, digital approaches and other novel strategies could also help engage and support other family members and friends who also influence the child’s home environment. Finally, it is well documented that numerous genetic, behavioral, and environment factors contribute to increased risk and childhood obesity disparities [94]. In alignment with socioecological models of childhood obesity, a comprehensive family-centered behavioral intervention may be a necessary, but insufficient component to reverse childhood obesity in a region with a myriad of health inequities. As such, the CAB partnership and structure should be expanded to allow for a more comprehensive community approach focused on addressing childhood obesity inequities [95].
Though beyond the scope of this current paper, a more thorough examination of our CER trial data are also warranted. First, the impact of engagement on outcomes deserves further investigation, as preliminary descriptive analysis reveals emergent patterns of low versus high engaged families across both iChoose and Family Connections programs. Second, individual-level program maintenance could further impact decisions pertaining to superiority of one program over the other (though completion of 12-month maintenance remains uncertain due to the COVID-19 public health). Finally, systematic analysis of mixed-methods interviews collected at data assessment appointments is in progress and will help further elucidate challenges and future opportunities to support family engagement and program effects.
Several study limitations should be noted. First, while our findings contribute to the sparse literature on childhood obesity intervention effect on health disparate regions, it may have limited generalizability beyond the study region. Second, the sample size for self-reported secondary outcomes among children is lower than anticipated and originally powered, due to lowering the inclusion age from 8–12 to 5–12 in the third cohort to meet accrual needs. These limitations should be considered within strengths of the RCT trial design, objective assessment of primary outcomes, appropriate statistical analysis to account for missing data, and robust application of the RE-AIM planning and evaluation framework. Likewise, the systems-based and CBPR approach, whereby research occurred within the existing community infrastructure is a study strength.