The Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents, and Providers (TEAM UP) randomized clinical trial investigates the effectiveness of family-based behavioral treatment with enhanced standard of care compared with enhanced standard of care alone for reducing childhood obesity.
Key Points
Question
Is family-based behavioral treatment (FBT) with enhanced standard of care (ESOC) more effective than ESOC alone for reducing childhood obesity?
Findings
In this multicenter pragmatic randomized clinical trial that randomized 730 children aged 6 to 15 years across 41 primary care practices, ESOC+FBT significantly reduced percent median BMI compared with ESOC alone. Nearly half of the children receiving ESOC+FBT achieved clinically meaningful weight reduction, and both groups experienced reductions in percent median BMI.
Meaning
Study results show that FBT delivered with ESOC in primary care improved child weight outcomes compared with ESOC alone and was feasible across a geographically and socioeconomically diverse population.
Abstract
Importance
Families have limited access to pediatric weight management services.
Objective
To compare the effectiveness of enhanced standard of care (ESOC) with family-based behavioral treatment (FBT) vs ESOC alone in reducing percent over median body mass index (percent median BMI) among children and adolescents with obesity. ESOC+FBT was hypothesized to reduce relative weight more than would ESOC alone.
Design, Setting, and Participants
This was a pragmatic, comparative-effectiveness randomized clinical trial (2019-2024). Data collectors were blinded, and patients were followed up at 18 months. The setting included a total of 41 primary care clinical practices in Louisiana, New York, Missouri, and Illinois. Children and adolescents aged 6 to 15 years with obesity were referred by their primary care practitioner (PCP) or self-selected into the trial.
Interventions
ESOC was led by the PCP and intensified depending on a child’s response. ESOC+FBT included all ESOC components plus meetings with an FBT interventionist, focusing on nutritious eating, physical activity, positive parenting strategies, and management of social and environmental cues. Both interventions lasted 12 months.
Main Outcomes and Measures
Change in percent median BMI at 12 months (end of treatment).
Results
A total of 1631 parents completed the web screen for their child, and 901 parent-child dyads were excluded or declined participation before randomization. The final sample of 730 children, each with a participating parent, had a mean (SD) age of 10.8 (2.5) years, 387 (54%) were female, 337 (47%) had Medicaid, and 160 (22%) had food insecurity. At the end of the treatment period, children in the group receiving ESOC+FBT experienced a significant reduction in percent median BMI (−6.4; 95% CI, −8.29 to −4.43) vs ESOC (−2.6; 95% CI, −4.46 to −0.71), with a mean between-group difference of −3.8 units (95% CI, −6.20 to −1.34 units; P = .002). Children’s quality of life improved across both treatment arms at months 12 and 18. Similarly, weight-associated quality of life improved in both treatment arms, with greater improvements in ESOC+FBT at the end of the treatment period (6.8; 95% CI, 5.33-8.30 vs 4.8; 95% CI, 3.40-6.17; difference, 2.0 units; 95% CI, 0.05-4.00 units). There were no adverse events related to trial participation.
Conclusions and Relevance
Results of this randomized clinical trial show that ESOC+FBT demonstrated a significantly larger reduction in child percent median BMI than did ESOC alone. These findings support the added value of incorporating FBT into pediatric primary care settings and its feasibility in reaching a geographically and socioeconomically diverse patient population.
Trial Registration
ClinicalTrials.gov Identifier: NCT03843424
Introduction
One in 5 children aged 2 to 19 years have obesity, contributing to cardiometabolic risk and poor quality of life. Integrating behavioral weight management treatment into primary care is recommended for the management of childhood obesity. The American Academy of Pediatrics clinical practice guideline recommends intensive health behavior and lifestyle treatment as an effective approach that practitioners should offer to all children aged 6 to 17 years with obesity, including 26 hours or more of treatment over a 3- to 12-month period. Family-based behavioral treatment (FBT), an exemplar of this approach, is a multicomponent intervention that targets diet, physical activity, behavioral skills, and parenting, while facilitating support within both family and peer environments. However, the guideline recognizes that these treatments are not available to all families, and primary care practitioners often deliver the best-available intensive treatment based on what is feasible. This care, referred to as enhanced standard of care (ESOC) in the present trial, is led by the primary care practitioner (PCP) and gradually intensifies depending on a child’s response to care, often fewer hours than FBT.
We report the results of a pragmatic comparative-effectiveness trial of these 2 models of care for childhood obesity, both guideline-concordant and embedded within primary care. We hypothesized that children who received ESOC combined with FBT (ESOC+FBT) would achieve greater reductions in relative weight than would children receiving ESOC alone.
Methods
Trial Design and Oversight
The Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents, and Providers (TEAM UP) trial was a comparative-effectiveness randomized clinical trial conducted in 41 primary care clinical practices between 2019 and 2024 in Louisiana, New York, Missouri, and Illinois. The trial protocol is available in Supplement 1. The parent of the participating child and/or legal guardian (hereafter referred to as parent) completed a web screen, phone screen, and screening visit to confirm eligibility. Data were collected using Research Electronic Data Capture (REDCap [Vanderbilt University]). Both parent and child completed the baseline visit and were then randomly assigned using the REDCap randomization module designed by the statistician, blocked within clinical practice, and stratified by child sex and child race (collected races included American Indian or Alaska Native, Asian, Black or African American, Middle Eastern or North African, multiracial, other race, or unknown race; parents identified children as Hispanic or Latino or not Hispanic or Latino), to ESOC or ESOC+FBT. To characterize the sample, at baseline, parents reported child race and ethnicity using US Census categories and household food insecurity using a validated 2-item survey. Assessments occurred at months 6 (midtreatment), 12 (end of treatment), and 18 (follow-up). Parents provided written informed consent and children provided assent. The institutional review board of Washington University in St. Louis approved the protocol. Data were collected by blinded research staff. The Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines were followed.
Patients and Trial Groups
The primary inclusion criteria for the child were ages 6 to 15 years and body mass index (BMI) greater than or equal to the 95th percentile. Exclusion criteria included children for whom the PCP or site principal investigator determined the study was clinically or medically inappropriate, including significant eating disorder symptomatology (eMethods in Supplement 2) or chronic conditions and/or taking medications that substantially impacted growth, appetite, weight, and/or physical activity participation.
The full study design and ESOC and ESOC+FBT intervention arms, which are delivered to the family unit, have been described previously (Figure 1). FBT is a multicomponent evidence-based intervention that uses a variety of behavioral techniques to promote healthy eating and physical activity, positive parenting, and support within family and peer contexts. Interventionists (including registered dietitians, licensed social workers, and community health workers) were existing clinic staff whenever possible. Interventionists completed ongoing training, including weekly supervision sessions with an expert study staff member. FBT included the following: (1) the Traffic Light Eating and Activity Plans, a family-friendly system that uses color-coding to promote greater consumption of high-nutrient, low-energy-dense vegetables and increased physical activity (GREEN) while reducing low-nutrient, high-energy-dense foods and sedentary behaviors (RED); (2) behavioral strategies and parenting techniques, including stimulus control (eg, modifying the home environment to support healthy habits), self-monitoring, goal setting, and problem-solving (parents were encouraged to praise and positively reinforce their children’s targeted behaviors, as well as model their own healthy behaviors and attitudes); and (3) social facilitation, which teaches parents to create a supportive family and peer environment conducive to healthy weight-control behaviors and body esteem. Children were taught skills to build peer support and to manage negative peer and family interactions (eg, teasing).
Figure 1. Flowchart Illustrating How Families Progressed Through ESOC and ESOC+FBT in the TEAM UP Trial.
ESOC indicates enhanced standard of care; FBT, family-based behavioral treatment; TEAM UP, Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents, and Providers.
FBT visits began as soon as feasible after randomization and concluded within 12 months. FBT began with planned weekly visits for 6 months, then transitioned to biweekly visits for 3 months and to monthly visits for 3 months for up to 26 to 33 sessions. Families were seen in person or had telehealth sessions of approximately 30 to 50 minutes in length; visits incorporated taking parent and child weights, reviewing self-monitoring logs, connecting weight change to energy-balance behaviors, problem-solving barriers, setting goals for the next meeting, and reviewing treatment handouts. FBT interventionists used a dashboard in REDCap to manage treatment and facilitate oversight and supervision. This information dashboard was also used to calculate dose, fidelity, engagement, and family behavioral changes. For care coordination, interventionists communicated with the child’s PCP at least quarterly regarding patient progress, attendance, and medical concerns.
All enrolled patients in both treatment arms received ESOC, delivered by the child’s trained PCP based on the American Academy of Pediatrics Obesity Clinical Decision Support Chart and Next Steps resource manual. ESOC was initially developed to follow the 2007 Expert Committee recommendations from the American Medical Association and also aligned with the 2023 American Academy of Pediatrics guideline to deliver the best available intensive treatment upon diagnosis of obesity. To build capacity to deliver best-practice, specialized care, the Project Extension for Community Healthcare Outcomes (ECHO) model was used to connect practitioners with experts and facilitate case conferencing and peer support; this model was also used for FBT interventionist training. Before enrollment, practitioners were required to participate in or view online recordings of at least 6 to 8 core sessions (20- to 30-minute didactic portions followed by 30-minute case conferencing). Topics included obesity pathophysiology, assessment and management, practice workflow and coding, weight bias and stigma, cultural considerations, and behavioral counseling. After enrollment commenced, practitioners were offered monthly (later bimonthly) optional 1-hour group sessions following the same format.
The child’s PCP provided in-office or telehealth counseling; frequency of care was based on response, clinical practice capacity, family motivation, child’s physical and emotional development, and weight status. Following clinical practice guidance and depending on family availability and interest as well as the child’s response to treatment, practitioners were encouraged to offer at least 6 up to 21 ESOC visits over the course of the 12-month intervention, at the discretion of the practitioner. At these visits, practitioners assessed weight progress, child and family motivation, and readiness to change; problem-solved barriers to lifestyle change; and used motivational interviewing to support families in setting dietary and physical activity goals and identifying strategies to support behavior change.
Outcomes
Outcomes were assessed by blinded data assessors at baseline and months 6 (midtreatment), 12 (end of treatment), and 18 (follow-up). The primary outcome was change in percent over the median BMI (percent median BMI) between baseline and month 12. The percent from median BMI (also referred to as percent overweight) was defined as follows:
| [(child’s BMI − the median BMI) / (median BMI)] × 100, |
where the median BMI is for the child’s sex and age.
Median BMI was normalized for child age and sex based on nationally representative data. Height and weight were measured in person or remotely, per standardized protocol, or extracted from medical records (comprising 21% of follow-up data). A within-trial validation study indicated high concordance between in-person and remotely collected heights and weights. To confirm the robustness of findings, post hoc analyses were repeated for exploratory BMI measures, including change in BMI percentile, BMIp95 (percent over the 95th BMI percentile), and BMI z score using extended growth charts, and proportion meeting the clinically meaningful threshold for BMI z score reduction of at least 0.25 was examined between treatment arms. All BMI measures were based on the age of the child, in months, at the time of assessment.
Exploratory outcomes included child-reported Pediatric Quality of Life (PedsQL) and parent-reported Sizing Them Up, which assessed the impact of weight on the child’s health and daily functioning over the last month; child lipids and blood pressure extracted from the child’s electronic health record (only available for a subset of patients); and parent weight change. At each assessment time point, families reported any unexpected health events that occurred for the child.
Statistical Analysis
To establish our study sample size, we assumed a mean (SD) 12-month reduction in percent median BMI of 2.5 (10.1) for the ESOC group, based on prior results. A review of 7 studies reporting results from FBTs conducted in specialty clinics found mean (SD) reduction of 10.6 (15.3) in percent median BMI. We anticipated that delivering the ESOC and FBT in primary care would dampen the impact; therefore, we adjusted the estimate to assume an 8-unit reduction in percent median BMI. Thus, to achieve at least 80% power, allowing for 30% attrition in a population that can be difficult to retain, we needed an enrollment of 728 child participants. During the trial, before blinding was lifted and in consultation with the data safety monitoring board, we reduced the target sample size from 1296 to 728 child-parent dyads to account for the tremendous recruitment challenges posed by the COVID-19 pandemic. The reduced sample size retained sufficient power for the primary outcome but not for exploratory race × sex interaction analyses. Differences within sex and race groups were examined as a priori planned exploratory analyses.
Means (SD) or frequency distributions (for categorical variables) were used to summarize the cohort’s characteristics. Race was categorized as Black or African American, multiracial or other, and White. The analysis of child percent median BMI, quality of life (PedsQL and Sizing Them Up), and parent weight outcomes used a linear mixed model (LMM) with group, visit, and group × visit interaction, adjusting for geographic site, child age at visit, sex, and race assuming an autoregressive covariance matrix for repeated observations within person and a random effect for clinical practice with a variance components covariance structure. Modeling results are presented as least mean square estimates and 95% CIs. A similar generalized LMM was used to analyze differences between groups for clinically meaningful BMI reduction, presented as odds ratios (ORs) and 95% CIs. Contrast statements were used to obtain differences between and within groups at each follow-up assessment (6, 12, and 18 months). The trajectory of percent median BMI for both groups is presented as raw profile plot.
Baseline characteristics for the children with and without observations at the 12-month follow-up visit were examined to assess representativeness of the analytic sample, along with a completers analysis for those who had observations at 12 and 18 months. Additionally, we conducted a tipping point analysis, which assessed the degree of reduction needed in percent median BMI among the participants receiving ESOC with missing data at the 12-month follow-up visit to reverse the findings for the primary outcome. Heterogeneity of effects was examined by baseline age, sex, race, and ethnicity. A preplanned sensitivity analysis examined effects by telehealth delivery and by randomization occurring during the peak COVID-19 pandemic (April 1, 2020, to April 1, 2021) or not. An LMM was used for the analysis, adjusting for days since baseline, using contrasts to obtain the between- and within-group differences. All outcomes other than the between-group comparison of percent median BMI at 12 months are considered exploratory, and the associated CIs were not adjusted for multiplicity and, thus, are not considered hypothesis testing. All P values were 2-sided, and P <.05 was considered statistically significant. Analyses used SAS, version 9.4 (SAS Institute).
Results
Trial Patients
A total of 1631 parents completed the web screen for their child, and 901 parent-child dyads were excluded or declined participation before randomization. A total of 730 parent-child dyads were randomized to ESOC (n = 376) or ESOC+FBT (n = 354), and 723 patients were included in the analyses (Figure 2). In the analytic sample, youth had a mean (SD) age of 10.8 (2.5) years, 387 (53.5%) were female, 249 (34.4%) were parent-identified as Black or African American, 78 (10.8%) were identified as Hispanic or Latino, 96 (13.3%) were identified as multiracial or other race, and 378 (52.3%) were identified as White (Table 1). Nearly half (337 [46.6%]) were insured by Medicaid, and 160 parents (22.1%) reported household food insecurity. Characteristics for those who did and did not complete the month 12 primary outcome assessment were similar to those of the full sample (eTable 1 in Supplement 2).
Figure 2. Flowchart Showing the Consolidated Standards of Reporting Trials (CONSORT) Diagram of Patients in the TEAM UP Trial.
At web screen, 52 parents completed for a second child; at phone screen, 13 parents completed for a second child; and at screening visit, 3 families completed for a second child. These are included in the total numbers above for each stage of screening; they were all ineligible and did not proceed. Overall, 41 families withdrew from the ESOC arm and 54 families withdrew from the ESOC+FBT arm; their data were retained in the intent-to-treat analysis. ESOC indicates enhanced standard of care; FBT, family-based behavioral treatment; TEAM UP, Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents, and Providers.
Table 1. Characteristics of the Patients at Baseline.
| Characteristic | ESOC (n = 374) | ESOC+FBT (n = 349) | Overall (N = 723) |
|---|---|---|---|
| Age, mean (SD), y | 10.9 (2.63) | 10.6 (2.39) | 10.8 (2.52) |
| Weight, mean (SD), kg | 75.3 (26.30) | 72.2 (23.46) | 73.8 (25.00) |
| Percent median BMI, mean (SD) | 76.7 (29.54) | 76.6 (29.37) | 76.7 (29.44) |
| BMI percentile, mean (SD) | 98.6 (1.45) | 98.6 (1.38) | 98.6 (1.42) |
| BMIp95, mean (SD) | 130.8 (21.19) | 130.8 (21.49) | 130.8 (21.32) |
| BMI z score, mean (SD) | 2.5 (0.75) | 2.6 (0.80) | 2.6 (0.77) |
| Sex, No. (%) | |||
| Female, No. (%) | 199 (53.2) | 188 (53.9) | 387 (53.5) |
| Male, No. (%) | 175 (46.8) | 161 (46.1) | 336 (46.5) |
| Race, No. (%) | |||
| Black or African American | 122 (32.6) | 127 (36.4) | 249 (34.4) |
| Multiracial or other racea | 51 (13.6) | 45 (12.9) | 96 (13.3) |
| White | 201 (53.7) | 177 (50.7) | 378 (52.3) |
| Ethnicity, No. (%) | |||
| Hispanic or Latino(a) | 45 (12.0) | 33 (9.5) | 78 (10.8) |
| Insured by Medicaid, No. (%) | 175 (46.8) | 162 (46.4) | 337 (46.6) |
| Household food insecure, No. (%) | 81 (21.7) | 79 (22.6) | 160 (22.1) |
Abbreviations: BMI, body mass index; BMIp95, BMI percent over the 95th percentile; ESOC, enhanced standard of care; FBT, family-based behavioral treatment.
Includes American Indian or Alaska Native (4), Asian (5), Middle Eastern or North African (1), multiracial (59), other (18) or unknown race (9) when parents marked “don’t know” for their child’s race.
For the analytic sample, retention at month 18 was 85.8%. Patients attended a mean (SD) of 4.0 (4.24) ESOC sessions delivered by the PCP, with no difference by condition (mean [SD], 4.0 [3.78] in ESOC; 3.9 [4.71] in ESOC+FBT). Patients in the ESOC+FBT group attended a mean (SD) of 16.7 (12.2) FBT sessions, with lower attendance among African American patients, patients insured by Medicaid, and families with food insecurity (eTable 2 in Supplement 2).
Relative Weight Loss
Children in the ESOC+FBT had a significantly greater reduction in percent median BMI than the group receiving ESOC alone did at month 12 (group difference, −3.8 units; 95% CI, −6.20 to −1.34 units; P = .002) and at months 6 and 18 (Table 2 and Figure 3). Within the ESOC+FBT group, children had a reduction in percent median BMI at month 12 (−6.4; 95% CI, −8.29 to −4.43), and, to a lesser extent, children in the ESOC arm had a reduction in percent median BMI at month 12 (−2.6; 95% CI, −4.46 to −0.71). Similarly, children in both arms reduced percent median BMI at months 6 and 18 (Table 2). Exploratory BMI metrics align with primary findings (eTable 3 in Supplement 2). Children receiving ESOC+FBT had higher odds of meeting a clinically meaningful threshold of BMI z reduction of greater than or equal to 0.25 (month 6: 2.1; 95% CI, 1.43-3.10; month 12: 1.5; 95% CI, 1.05-2.14; month 18: 1.5; 95% CI, 1.05-2.07). Completers analysis was conducted with similarities between results (eTable 4 in Supplement 2). Findings were similar within age, sex, race, and ethnic groups (eTable 5 in Supplement 2). The tipping point analysis demonstrated that those participants who had a missing 12-month assessment would need a decrease of 10 units in percent median BMI to nullify the findings of the primary outcome; this magnitude is nearly 4 times the reduction in the participants who had 12-month assessments. This result illustrates the robustness of the findings to missing data (eFigure in Supplement 2). The dates of physician-obtained height and weight in the medical record for missing assessments at the 12-month visit did not substantially differ from the allowed study visit window (eTable 6 in Supplement 2).
Table 2. Change From Baseline in Outcomes Throughout the TEAM UP Triala.
| Outcome | ESOCb | ESOC+FBTb | Differencec |
|---|---|---|---|
| Weight loss outcome | |||
| Percent median BMI | |||
| At 6 mo | −1.8 (−3.13 to −0.56) | −5.6 (−6.98 to −4.30) | −3.8 (−5.56 to −2.03) |
| At 12 mo | −2.6 (−4.46 to −0.71) | −6.4 (−8.29 to −4.43) | −3.8 (−6.20 to −1.34)d |
| At 18 mo | −3.4 (−5.80 to −1.00) | −7.7 (−10.19 to −5.27) | −4.3 (−7.25 to −1.41) |
| Quality-of-life outcomes | |||
| Quality of lifee | |||
| At 6 mo | 0.6 (−0.67 to 1.85) | 2.3 (1.00 to 3.66) | 1.7 (−0.08 to 3.55) |
| At 12 mo | 2.5 (0.93 to 4.15) | 4.3 (2.54 to 6.00) | 1.7 (−0.58 to 4.05) |
| At 18 mo | 2.8 (0.97 to 4.63) | 4.1 (2.18 to 6.11) | 1.3 (−1.24 to 3.94) |
| Weight-related quality of lifef | |||
| At 6 mo | 3.7 (2.64 to 4.73) | 5.1 (4.00 to 6.21) | 1.4 (−0.08 to 2.92) |
| At 12 mo | 4.8 (3.40 to 6.17) | 6.8 (5.33 to 8.30) | 2.0 (0.05 to 4.00) |
| At 18 mo | 5.6 (4.02 to 7.25) | 7.8 (6.10 to 9.55) | 2.2 (−0.07 to 4.45) |
Abbreviations: BMI, body mass index; ESOC, enhanced standard of care; FBT, family-based behavioral treatment.
Due to small numbers of enrolled participants at 2 practices each in 2 different geographic sites (Missouri and New York), each of these pairs of clinical practices were combined for statistical purposes, which reduced the total number of clinical practices used during modeling by 2.
Adjusted means (95% CIs) resulting from the model using contrasts to calculate change from baseline within group.
Adjusted difference resulting from the model between the change in ESOC+FBT and the change in ESOC at each assessment visit.
Primary outcome, P value = .002.
Child-reported Pediatrics Quality of Life (PedsQL); range, 0 to 100 with higher scores indicating higher quality of life.
Parent-reported Sizing Them Up; range, 0 to 100 with higher scores indicating higher quality of life.
Figure 3. Line Graph Showing Percent Median BMI Throughout the TEAM UP Trial.
Adjusted means and SEs at each assessment period using a linear mixed model with group, visit, and group × visit interaction, adjusting for geographic site, child age at visit, sex, and race, assuming an autoregressive covariance matrix for repeated observations within-person and a random effect for the clinical practice with a variance components covariance structure and the appropriate contrasts. Month 6 was midtreatment, month 12 was end of treatment, and month 18 was follow-up. BMI indicates body mass index; ESOC, enhanced standard of care; FBT, family-based behavioral treatment; TEAM UP, Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents, and Providers.
Those who engaged in some or all telehealth for FBT experienced greater reduction in percent median BMI and also greater attendance to FBT (eTables 7 and 8 in Supplement 2). For families enrolled during peak COVID-19 pandemic, treatment response was blunted in the ESOC arm but remained similar for ESOC+FBT (eTable 7 in Supplement 2).
Changes in Quality-of-Life Outcomes
Children reported improved quality of life in both arms at months 12 and 18. Based on parental report, children in both arms increased weight-associated quality of life at each time point. Compared with ESOC, the group receiving ESOC+FBT showed greater improvements at the end of the treatment period (6.8; 95% CI, 5.33-8.30 vs 4.8; 95% CI, 3.40-6.17), with a 2.0-unit (95% CI, 0.05-4.00 units) higher increase at month 12 (Table 2). Child clinical outcomes and parent weight change were similar across treatment arms (eTables 9 and 10 in Supplement 2). There were no unanticipated problems or adverse events deemed likely related to study participation.
Discussion
Children and adolescents receiving ESOC+FBT achieved significantly greater reduction in percent median BMI than those receiving ESOC alone, demonstrating the added value and feasibility of incorporating FBT into pediatric primary care. Children in the ESOC and ESOC+FBT arms experienced reduced relative weight and improved quality of life, supporting the utility of both approaches. The positive effects of ESOC+FBT continued during the COVID-19 pandemic, a time marked by a global increase in childhood obesity and challenges in delivering health care.
The magnitude of effect (ie, reduction in percent median BMI) in the ESOC+FBT treatment group was 6.4 units at month 12 and 7.7 units at the 18-month follow-up, which aligns with a review of 8 FBT trials that observed an average 8-unit reduction. Nearly half (42%) of children receiving ESOC+FBT met the threshold for clinically meaningful BMI z score reduction at month 18 follow-up, a level associated with clinically significant improvements in cardiometabolic risk and reduced mortality. Improvements in quality of life were also meaningful; children receiving ESOC+FBT improved by 4.3 units at 12 months, which met the minimal important difference threshold and was larger than the 0.5-unit improvement in a systematic review. Such improvements in quality of life are particularly important as children with obesity are at higher risk for poorer mental health compared with peers with healthy weight.
This trial was innovative for its broad eligibility criteria, resulting in socioeconomic diversity, including nearly half of participants qualifying for Medicaid. The trial was highly pragmatic; many of the FBT interventionists were clinic employees who billed insurance, and PCPs billed for ESOC. The robustness of the results is striking given the pragmatic nature of the intervention delivery and broad inclusion criteria.
Future research directions include examining pharmacological adjuncts to enhance the magnitude and maintenance of effect for these efficacious obesity treatments. Even with the emergence of glucagon-like peptide-1 receptor agonists, intensive behavioral treatment remains fundamental to obesity care, has shown cost-effectiveness, and, in this trial, was billable to both Medicaid and private insurance. Implementation science trials are needed to test strategies for integrating FBT into routine clinic operations.
Limitations
This study has some limitations, which included disruptions in enrollment and treatment delivery during the COVID-19 pandemic. The flexibility to conduct sessions remotely and in-person was important for addressing scheduling barriers during pandemic-related disruptions in health care delivery, and the broader shift toward telehealth. Although up to 26 to 33 FBT sessions were prescribed, mean (SD) attendance was 16.7 (12.2) sessions. The US Preventive Services Task Force evidence review demonstrated a dose gradient in which greater contact hours were associated with larger relative weight reductions, supporting recommendations for intensive behavioral interventions delivering at least 26 contact hours. Lower-intensity interventions nevertheless still produced weight reductions relative to control conditions, and implementation studies show that each additional session attended predicts improved child weight outcomes, supporting an incremental dose-response relationship. Treatment dose likely reflects both family-level and structural factors, including scheduling flexibility, insurance coverage and copayments, telehealth availability, clinic hours, and in-person attendance requirements for some clinics. Additionally, lower FBT attendance among African American patients, Medicaid-insured patients, and families with food insecurity suggests that structural and access-related barriers may have limited treatment exposure. Families were also asked to modify household environments, monitor health behaviors, and employ positive parenting practices, which may create additional demands for some households. Future work should evaluate telehealth vs in-person delivery and other flexible models that optimize engagement while maintaining treatment effectiveness.
Conclusions
In conclusion, this highly pragmatic randomized clinical trial reached a geographically and socioeconomically diverse patient population and provided evidence that ESOC+FBT was superior to ESOC in reducing child relative weight. Nearly half of the patients receiving ESOC+FBT achieved a clinically meaningful weight reduction, demonstrating both feasibility and effectiveness of embedding FBT in primary care.
Trial Protocol.
eMethods.
eTable 1. Baseline Characteristics for those Included in the Primary Outcome Analysis in the Overall Sample and by Treatment Assignment
eTable 2. Number of Completed ESOC and FBT Overall and by Baseline Demographic Characteristics
eTable 3. Change From Baseline in the Exploratory BMI Outcomes Throughout the TEAM UP Trial
eTable 4. Completers Analysis for Participants Attending the Primary Outcome Visit Only and for Those Attending the Primary Outcome Visit and the Final Study Follow-Up Visit
eTable 5. Change in Child % Median BMI Within Each Age, Sex, Race, and Ethnic Group by Treatment Arm in the TEAM UP Trial
eFigure. Tipping Point Assessment of the Primary Outcome to Determine the Degree of Decrease in % Over Median BMI Necessary Among all Missing Participants in the ESOC Only Group Needed to Nullify the Primary Outcome Findings
eTable 6. Days Between Target 12-Month Visit Date and Date of Clinically Measured Weight and Height Extracted From the Electronic Health Record
eTable 7. Sensitivity Analysis Examining Change From Baseline in Primary Outcome (% Median BMI) Throughout the TEAM UP Trial by Telehealth Delivery and by COVID-19 Pandemic
eTable 8. Demographic Characteristics of Participants Who Utilized Telehealth vs Those Who Did Not for FBT Sessions
eTable 9. Change in Clinical Outcomes From Health Records by Treatment Arm in the TEAM UP Trial
eTable 10. Parent Percent Weight Change by Treatment Arm in the TEAM UP Trial
Nonauthor Collaborators. TEAM UP Research Group.
Data Sharing Statement.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Trial Protocol.
eMethods.
eTable 1. Baseline Characteristics for those Included in the Primary Outcome Analysis in the Overall Sample and by Treatment Assignment
eTable 2. Number of Completed ESOC and FBT Overall and by Baseline Demographic Characteristics
eTable 3. Change From Baseline in the Exploratory BMI Outcomes Throughout the TEAM UP Trial
eTable 4. Completers Analysis for Participants Attending the Primary Outcome Visit Only and for Those Attending the Primary Outcome Visit and the Final Study Follow-Up Visit
eTable 5. Change in Child % Median BMI Within Each Age, Sex, Race, and Ethnic Group by Treatment Arm in the TEAM UP Trial
eFigure. Tipping Point Assessment of the Primary Outcome to Determine the Degree of Decrease in % Over Median BMI Necessary Among all Missing Participants in the ESOC Only Group Needed to Nullify the Primary Outcome Findings
eTable 6. Days Between Target 12-Month Visit Date and Date of Clinically Measured Weight and Height Extracted From the Electronic Health Record
eTable 7. Sensitivity Analysis Examining Change From Baseline in Primary Outcome (% Median BMI) Throughout the TEAM UP Trial by Telehealth Delivery and by COVID-19 Pandemic
eTable 8. Demographic Characteristics of Participants Who Utilized Telehealth vs Those Who Did Not for FBT Sessions
eTable 9. Change in Clinical Outcomes From Health Records by Treatment Arm in the TEAM UP Trial
eTable 10. Parent Percent Weight Change by Treatment Arm in the TEAM UP Trial
Nonauthor Collaborators. TEAM UP Research Group.
Data Sharing Statement.
