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.

What’s Known on This Subject:

Pediatric weight management interventions (PWMIs) in which ≥26 contact hours are offered have been found to be effective in improving BMI. However, in few studies have researchers compared the effectiveness of treatment approaches that optimize the care of vulnerable children.

In this randomized trial in a largely Hispanic, low-income population, a PWMI delivered in an healthy weight clinic was effective in improving BMI. The noninferiority of a PWMI delivered in a community setting was not established.

Childhood obesity represents a major threat to public health.1  The highest prevalence of childhood obesity in the United States is among Hispanic (25.8%) and non-Hispanic Black (22.0%) children, compared with white (14.1%) children, and increases as income decreases.2  The US Preventive Services Task Force offers evidence that pediatric weight management interventions (PWMIs) that focus on lifestyle changes and deliver ≥26 contact hours are important interventions.3  Evidence suggests that multidisciplinary healthy weight clinics (HWCs) that provide access to a team of a pediatric provider, dietitian, and community health worker are effective.4,5

Intensive, community-based interventions for pediatric weight management offer an alternative to clinical programs. For example, the Mind, Exercise, Nutrition…Do it! (MEND) program, a community-based intervention, has revealed reductions in BMI after 18 2-hour group sessions held twice weekly, followed by a 12-week free swimming pass.68  The MEND program was adapted by the Young Men’s Christian Association (YMCA) to a program called Healthy Weight and Your Child (HWYC). The HWYC could provide an additional and potentially less costly option if found to be noninferior to traditional clinically based models and allow for treatment to reach families in other settings. Such comparative studies, and in particular those that include low-income, Hispanic children, have not been previously conducted.

We designed the Clinic and Community Approaches to Healthy Weight Trial to evaluate the comparative effectiveness of a HWC delivered in federally qualified health centers (FQHCs) and a modified Healthy Weight and Your Child (M-HWYC) delivered in YMCAs in 2 communities in Massachusetts. We hypothesized that the M-HWYC would be (1) noninferior to the HWC in improving percentage change of the 95th percentile (%BMIp95) and that (2) both interventions would reduce BMI and %BMIp95 compared with 8 demographically similar comparison sites.

The Clinic and Community Approaches to Healthy Weight Trial was a randomized trial conducted in 2 FQHCs and 2 YMCAs serving the same 2 communities. The study design has been previously described (Fig 1).9  All study activities were approved by the Institutional Review Board at the Massachusetts Department of Public Health. The trial has been recorded in the clinicaltrials.gov national registry of randomized trials (NCT03012126). There were no adverse events.

FIGURE 1

Study design of the Clinic and Community Approaches to a Healthy Weight Trial. MA, Massachusetts.

FIGURE 1

Study design of the Clinic and Community Approaches to a Healthy Weight Trial. MA, Massachusetts.

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Eligibility criteria were (1) age 6.0 to 12.9 years at referral, (2) BMI ≥85th percentile, and (3) a parent who could speak English or Spanish. We excluded (1) children who did not have at least 1 guardian who was able to follow study procedures; (2) families who planned to leave the FQHC within the study time frame; (3) families for whom the intervention was inappropriate, as determined by the primary care clinician (eg, because of emotional or cognitive difficulties that would not allow them to participate; (4) children who were taking medications that substantially interfere with growth; and (5) children who had a sibling enrolled.

Recruitment began in December 2016 and continued through February 2018; data collection ended in September 2019. Children were referred to the study by their primary care provider at a visit in which a height and weight was obtained. After receiving the referral, research assistants called parents and/or guardians to confirm eligibility, obtain verbal consent, and complete a survey. Participants were randomly assigned at the end of the survey. Families were mailed a $25 gift card for completing each of the baseline, 6-month, and 12-month surveys, as well as up to 3$25 gift cards as incentives for attending 1 visit and completing one-third and completing two-thirds of the offered visits. The Consolidated Standards of Reporting Trials flow diagram is displayed in Fig 2.

FIGURE 2

Consolidated Standards of Reporting Trials participant flow diagram for the Clinic and Community Approaches to Healthy Weight Trial.

FIGURE 2

Consolidated Standards of Reporting Trials participant flow diagram for the Clinic and Community Approaches to Healthy Weight Trial.

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We randomly assigned participants using 2 randomization lists (1 for each FQHC) created by the data analyst. Lists were organized into blocks of 4 to keep the sizes of intervention groups similar, and assignment was concealed in numbered envelopes from those conducting the random assignment. Participants were randomly assigned in the order in which their consent was obtained. Follow-up surveys were completed by a different research assistant to ensure those assessing outcomes were blinded to intervention-arm assignment.

We had planned to enroll 400 children into the study and were able to enroll 407. We were powered at 91%, with N = 388 at follow-up to detect a clinically meaningful difference in BMI change.

Children in both interventions were exposed to quality-of-care improvements in their FQHC, which included primary care provider weight management training and text messages to guardians for self-guided behavior-change support. Automated text messages were sent 2 to 3 times per week with tips on how to make lifestyle changes and messages that supported social and emotional wellness and promoted community-resource use and resources for mitigating unmet social needs. In addition, we mailed everyone enrolled in the interventions community resources for mitigating unmet social needs.

The HWC provided a comprehensive, multidisciplinary team intervention and offered 30 hours of contact to the parent and/or guardian and child. Siblings were allowed to attend but were not included in the trial analysis. The team included a pediatrician or advanced practice clinician, community health worker, and dietitian, with access to mental health providers as needed. The HWC team used motivational interviewing for counseling and goal setting. For the first 6 months, participants were offered monthly group visits with other families, alternating with monthly individual visits with the multidisciplinary team. Each HWC visit, whether individual or group, was 1.5 hours in length. The group-visit curriculum included understanding health, healthy eating, healthy drink choices, physical activity, bullying, sleep and screen time, food label reading, and eating outside the home. In the second 6 months, participants were offered monthly individual visits with the multidisciplinary team. Participants received twice-monthly health-coaching calls (∼10 minutes in duration) from the community health worker or dietitian in the first 6 months and monthly health-coaching calls in the second 6 months.

The YMCA of the United States of America worked with 2 local YMCAs to train staff to implement a modified version of the HWYC intervention that included 16 weekly sessions, followed by 4 sessions every other week, ending with 5 monthly sessions, for a total of 25 sessions offered to the parent and/or guardian and child over 1 year. Siblings were allowed to attend but were not included in the trial analysis. Each session was 2 hours long. In total, the M-HWYC offered 50 contact hours. This modified intervention was different from the HWYC that is being implemented nationally, which contains 25 sessions delivered over 4 months versus over 12 months, as was offered in this intervention. Additionally, the national HWYC intervention is offered only to children with a BMI in the ≥95th percentile. Two group leaders provided support, education, and activities during each session, including a family huddle, which incorporates goal setting, a parent discussion, and 60 minutes of physical activity for the children, the last 30 minutes of which is for the whole family.

Eight demographically matched, comparison community health centers in Massachusetts were chosen. All BMI data from children aged 5.1 to 14.1 years were obtained from these health centers from December 2015 to September 2019 (N = 4037). This mirrored the ages and date ranges of electronic health record (EHR) BMI measurements we obtained for our intervention participants.

#### Primary Outcomes

The primary outcomes were change in BMI and %BMIp95 per year, calculated on the basis of the Centers for Disease Control and Prevention growth curves. Height and weight were collected by clinical staff per their clinical protocols at routine visits. We extracted age and longitudinal BMI data from the electronic records of all 10 health centers for 4425 children, aged 5.1 to 14.1 years, who received their primary care at these health centers. This provided a BMI trajectory preintervention for both the intervention participants and the comparison sites.

#### Secondary Outcomes

Secondary outcomes included lifestyle changes, including changes in screen time, physical activity, sleep duration, and sugary beverages for those enrolled in either the HWC or M-HWYC at baseline and 1 year.1016

#### Covariates

Race and/or ethnicity for intervention participants was collected via survey for comparison sites, and for any intervention participants missing race and/or ethnicity on the survey, it was collected from their EHR data. Income and parent BMI were collected via self-report on the baseline survey.

#### Noninferiority Analysis

We performed a 2-tailed, upper-bound 90% confidence interval (CI) noninferiority test of child %BMIp95 to examine if %BMIp95 change difference for the M-HYWC was appreciably inferior to that of the standard HWC intervention.9  Noninferiority was supported if the bounds of the 90% CI for the difference in %BMIp95 changes did not contain what we considered a minimally clinically important difference, on the basis of previous data (0.87).17  We stratified these results by severe obesity versus overweight or obesity.

#### Changes in BMI and %BMIp95 in the HWC and M-HWYC Versus Comparison Sites

We then examined changes in BMI and %BMIp95 and compared changes among each intervention arm to the comparison sites. To assess changes per year in BMI and %BMIp95, we used indicator variables for time and the intervention arm (HWC, M-HWYC, or comparison site). We performed an intention-to-treat analysis for children enrolled in the interventions with BMI measurements at follow-up (N = 388 [95%]). We used the MIXED procedure in SAS 9.4 (SAS Institute, Inc, Cary, NC) to fit mixed linear regression models with random intercepts and slopes. The models accounted for clustering of observations within individuals and within sites. There was a larger prevalence of Hispanic patients and higher baseline BMIs in the intervention groups compared with the comparison sites, so models were adjusted for these covariates. Given the increased prevalence of severe obesity enrolled in the intervention groups compared with the comparison sites, we examined severe obesity as an interaction term that was significant, and thus we present stratified results.

#### Lifestyle Change

We examined changes in lifestyle change from baseline to 1 year for those enrolled in the intervention arms for those who completed the follow-up survey (N = 330 [81%]). We examined guardian-reported change in sugary beverages, fast-food intake, sleep duration, screen time, and physical activity assessed via survey at baseline and 1 year. Models were adjusted for community, self-reported parent BMI category (lean or overweight or obesity) and household income (≤$20 000 vs >$20 000).

Figure 2 reveals the participant flow of the study. Clinicians referred 770 children; we attempted to contact 673 children. We enrolled 407 children: 201 to the HWC and 206 to the M-HWYC. At follow-up, we obtained BMI from 388 (95%) children. A total 4037 children were identified from the comparison sites, as detailed above. Table 1 reveals baseline characteristics of the study sample. Parental BMI and income were not balanced at random assignment between the HWC and M-HWYC. Compared with children in the comparison sites, those in the intervention groups had a higher percentage of Hispanic children and children with severe obesity.

TABLE 1

Baseline Characteristics of Participants in the Clinic and Community Approaches to a Healthy Weight Trial With 1-Year BMI (n = 388) and Subjects From 8 Comparison Sites, by Intervention Assignment

Baseline Participant Characteristics (N = 4425)OverallHWC, n = 191M-HWYC, n = 197PaComparison Sites, N = 4037Pb
Age at baseline,c mean (SD), y 9.60 (2.22) 9.52 (1.90) 9.52 (1.77) .98 9.60 (2.25) .77
Male sex, n (%) 2314 (52.29) 104 (54.45) 107 (54.31) .98 2103 (52.09) .69
Race and/or ethnicity, n (%) (n = 278 missing)
White (non-Hispanic) 677 (16.33) 4 (2.09) 2 (1.02) .62 671 (17.85) <.0001
Hispanic 2106 (50.78) 178 (93.19) 185 (93.91) — 1743 (46.37) —
Black (non-Hispanic) 1078 (25.99) 8 (4.19) 10 (5.08) — 1060 (28.20) —
Asian American 87 (2.10) 1 (0.52) 0 (0) — 86 (2.29) —
Other (non-Hispanic) 199 (4.80) 0 (0) 0 (0) — 199 (5.29) —
Baselinec BMI, mean (SD) 23.79 (4.49) 24.96 (4.82) 24.91 (4.63) .91 23.68 (4.45) <.0001
Baselinec %BMIp95, mean (SD) 107.64 (16.80) 113.32 (18.66) 113.36 (18.90) .98 107.09 (16.50) <.0001
Baselinec BMI category, n (%)
Overweight 1818 (41.08) 53 (27.75) 53 (26.90) .98 1712 (42.41) <.0001
Obesity 1736 (39.23) 81 (42.41) 84 (42.64) — 1571 (38.92) —
Severe obesity 871 (19.68) 57 (29.84) 60 (30.46) — 754 (18.68) —
Average No. EHR BMI measurements before enrollment date, mean (SD) 2.38 (1.42) 3.98 (2.40) 3.99 (2.19) .98 2.23 (1.19) <.0001
Average No. EHR BMI measurements ≥6 mo after enrollment, mean (SD) 2.33 (1.74) 4.23 (2.92) 3.81 (2.35) .12 2.17 (1.54) <.0001
Average years of follow-up EHR BMI measurements, mean (SD) 1.66 (0.51) 1.79 (0.47) 1.79 (0.46) .96 1.65 (0.51) <.0001
Randomized trial only (n = 388)
Average HWC or M-HWYC visits attended, mean (SD) 4.16 (5.34) 3.20 (3.68) 5.09 (6.44) <.0001 — —
Community
Community 1, mean (SD) 235 (60.57) 118 (61.78) 117 (59.39) .63 — —
Community 2, mean (SD) 153 (39.43) 73 (38.22) 80 (40.61) — — —
Parent age,d mean (SD) 35.13 (7.65) 34.86 (7.52) 35.40 (7.77) .49 — —
Born outside the United Statesd (n = 1 missing), n (%) 142 (36.69) 73 (38.22) 69 (35.20) .54 — —
Education levels combinedd (n = 4 missing), n (%)
Some high school or less 171 (44.53) 81 (43.09) 90 (45.92) .50 — —
High school degree 128 (33.33) 68 (36.17) 60 (30.61) — — —
Some college or higher 85 (22.14) 39 (20.74) 46 (23.47) — — —
Parent BMI categoryd (n = 32 missing), n (%)
Underweight 4 (1.12) 2 (1.16) 2 (1.09) .07 — —
Normal wt 57 (16.01) 29 (16.86) 28 (15.22) — — —
Overweight 94 (26.40) 57 (33.14) 37 (20.11) — — —
Class 1 obesity 87 (24.44) 39 (22.67) 48 (26.09) — — —
Class II obesity 67 (18.82) 25 (14.53) 42 (22.83) — — —
Class III obesity 47 (13.20) 20 (11.63) 27 (14.67) — — —
Income (dichotomous)d (n = 88 missing) n (%)
≤$20 000 205 (68.33) 93 (62.84) 112 (73.68) .04 — — >$20 000 95 (31.67) 55 (37.16) 40 (26.32) — — —
Parental depressiond 139 (35.82) 81 (42.41) 58 (29.44) .01 — —
Food insecured 189 (48.71) 87 (45.55) 102 (51.78) .22 — —
Housing insecured 112 (28.87) 54 (28.27) 58 (29.44) .80 — —
Baseline Participant Characteristics (N = 4425)OverallHWC, n = 191M-HWYC, n = 197PaComparison Sites, N = 4037Pb
Age at baseline,c mean (SD), y 9.60 (2.22) 9.52 (1.90) 9.52 (1.77) .98 9.60 (2.25) .77
Male sex, n (%) 2314 (52.29) 104 (54.45) 107 (54.31) .98 2103 (52.09) .69
Race and/or ethnicity, n (%) (n = 278 missing)
White (non-Hispanic) 677 (16.33) 4 (2.09) 2 (1.02) .62 671 (17.85) <.0001
Hispanic 2106 (50.78) 178 (93.19) 185 (93.91) — 1743 (46.37) —
Black (non-Hispanic) 1078 (25.99) 8 (4.19) 10 (5.08) — 1060 (28.20) —
Asian American 87 (2.10) 1 (0.52) 0 (0) — 86 (2.29) —
Other (non-Hispanic) 199 (4.80) 0 (0) 0 (0) — 199 (5.29) —
Baselinec BMI, mean (SD) 23.79 (4.49) 24.96 (4.82) 24.91 (4.63) .91 23.68 (4.45) <.0001
Baselinec %BMIp95, mean (SD) 107.64 (16.80) 113.32 (18.66) 113.36 (18.90) .98 107.09 (16.50) <.0001
Baselinec BMI category, n (%)
Overweight 1818 (41.08) 53 (27.75) 53 (26.90) .98 1712 (42.41) <.0001
Obesity 1736 (39.23) 81 (42.41) 84 (42.64) — 1571 (38.92) —
Severe obesity 871 (19.68) 57 (29.84) 60 (30.46) — 754 (18.68) —
Average No. EHR BMI measurements before enrollment date, mean (SD) 2.38 (1.42) 3.98 (2.40) 3.99 (2.19) .98 2.23 (1.19) <.0001
Average No. EHR BMI measurements ≥6 mo after enrollment, mean (SD) 2.33 (1.74) 4.23 (2.92) 3.81 (2.35) .12 2.17 (1.54) <.0001
Average years of follow-up EHR BMI measurements, mean (SD) 1.66 (0.51) 1.79 (0.47) 1.79 (0.46) .96 1.65 (0.51) <.0001
Randomized trial only (n = 388)
Average HWC or M-HWYC visits attended, mean (SD) 4.16 (5.34) 3.20 (3.68) 5.09 (6.44) <.0001 — —
Community
Community 1, mean (SD) 235 (60.57) 118 (61.78) 117 (59.39) .63 — —
Community 2, mean (SD) 153 (39.43) 73 (38.22) 80 (40.61) — — —
Parent age,d mean (SD) 35.13 (7.65) 34.86 (7.52) 35.40 (7.77) .49 — —
Born outside the United Statesd (n = 1 missing), n (%) 142 (36.69) 73 (38.22) 69 (35.20) .54 — —
Education levels combinedd (n = 4 missing), n (%)
Some high school or less 171 (44.53) 81 (43.09) 90 (45.92) .50 — —
High school degree 128 (33.33) 68 (36.17) 60 (30.61) — — —
Some college or higher 85 (22.14) 39 (20.74) 46 (23.47) — — —
Parent BMI categoryd (n = 32 missing), n (%)
Underweight 4 (1.12) 2 (1.16) 2 (1.09) .07 — —
Normal wt 57 (16.01) 29 (16.86) 28 (15.22) — — —
Overweight 94 (26.40) 57 (33.14) 37 (20.11) — — —
Class 1 obesity 87 (24.44) 39 (22.67) 48 (26.09) — — —
Class II obesity 67 (18.82) 25 (14.53) 42 (22.83) — — —
Class III obesity 47 (13.20) 20 (11.63) 27 (14.67) — — —
Income (dichotomous)d (n = 88 missing) n (%)
≤$20 000 205 (68.33) 93 (62.84) 112 (73.68) .04 — — >$20 000 95 (31.67) 55 (37.16) 40 (26.32) — — —
Parental depressiond 139 (35.82) 81 (42.41) 58 (29.44) .01 — —
Food insecured 189 (48.71) 87 (45.55) 102 (51.78) .22 — —
Housing insecured 112 (28.87) 54 (28.27) 58 (29.44) .80 — —

ANOVA, analysis of variance; —, not applicable.

a

P values were calculated with ANOVA for continuous variables and χ2 test for categorical variables.

b

P values were calculated with ANOVA for continuous variables and χ2 test for categorical variables.

c

Baseline is defined as the visit associated with enrollment date.

d

These fields were collected from survey data that were not administered to the comparison sites.

#### Noninferiority

The mean difference in %BMIp95 between the M-HWYC and the HWC (considered the standard intervention) was 0.75 (90% CI: 0.07 to 1.43). Because the CI contained 0.87, we were unable to establish noninferiority. When examining stratified data by overweight or obesity versus severe obesity category, we were again unable to establish noninferiority for the M-HWYC for those with overweight or obesity, but for those with severe obesity, the M-HWYC was noninferior (Fig 3, Table 2).

FIGURE 3

Noninferiority test in overall sample and stratified by baseline BMI category comparing upper bounds of the 90% CIs to the minimally clinically important margin (0.87). a Regression coefficient of interaction of treatment × time.

FIGURE 3

Noninferiority test in overall sample and stratified by baseline BMI category comparing upper bounds of the 90% CIs to the minimally clinically important margin (0.87). a Regression coefficient of interaction of treatment × time.

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TABLE 2

Noninferiority Effect Estimates for the Participants in the Clinic and Community Approaches to a Healthy Weight Trial With 12-Month BMI (n = 388)

%BMIp95, Mean Difference β (90% CI)
Overall (n = 388) 0.75 (0.07 to 1.43)
Overweight or obesity (n = 271) 1.35 (0.57 to 2.13)
Severe obesity (n = 117) −0.82 (−2.15 to 0.51)
%BMIp95, Mean Difference β (90% CI)
Overall (n = 388) 0.75 (0.07 to 1.43)
Overweight or obesity (n = 271) 1.35 (0.57 to 2.13)
Severe obesity (n = 117) −0.82 (−2.15 to 0.51)

M-HWYC compared with HWC, stratified by severe obesity. Unadjusted for covariates.

#### BMI Effectiveness Results

Table 3 reveals participants’ unadjusted and covariate-adjusted changes per year in BMI and %BMIp95. In the fully adjusted model, HWC participants’ BMI decreased by −0.23 (95%CI: −0.36 to −0.10) per year and %BMIp95 decreased by −1.03 (95% CI: −1.61 to −0.45) per year compared with the comparison sites. In the fully adjusted model, the M-HWYC participants’ BMI increased by 0.02 (95%CI: −0.11 to 0.16) per year and %BMIp95 decreased by −0.22 (95% CI: −0.83 to 0.38) per year compared with the comparison sites.

TABLE 3

Unadjusted and Adjusted BMI Changes per Year of Participants in the Clinic and Community Approaches to a Healthy Weight Trial With 1-Year BMI Compared With Subjects From 8 Comparison Sites, by Intervention Assignment (N = 4425)

Within-Group ChangeComparison Sites as Reference
Unadjusted, β (95% CI)Model 1,a β (95% CI)Model 2,b β (95% CI)Unadjusted, β (95% CI), n = 4425Model 1,a β (95% CI), n = 4147Model 2,b β (95% CI), n = 4147
BMI
HWC −0.39 (−0.53 to −0.25) −0.39 (−0.54 to −0.25) −0.32 (−0.46 to −0.19) −0.18 (−0.31 to −0.05) −0.18 (−0.31 to −0.04) −0.23 (−0.36 to −0.10)
M-HWYC −0.26 (−0.42 to −0.09) −0.26 (−0.42 to −0.09) −0.16 (−0.32 to 0.003) 0.02 (−0.12 to 0.15) 0.02 (−0.12 to 0.16) 0.02 (−0.11 to 0.16)
Comparison sites −0.10 (−0.15 to −0.05) −0.11 (−0.16 to −0.05) 0.07 (0.02 to 0.12) Reference Reference Reference
%BMIp95
HWC −2.24 (−2.87 to −1.60) −2.24 (−2.87 to −1.60) −2.15 (−2.79 to −1.52) −1.01 (−1.60 to −0.43) −1.00 (−1.58 to −0.42) −1.03 (−1.61 to −0.45)
M-HWYC −1.66 (−2.40 to −0.92) −1.66 (−2.40 to −0.92) −1.65 (−2.39 to −0.92) −0.18 (−0.79 to 0.42) −0.17 (−0.78 to 0.44) −0.22 (−0.83 to 0.38)
Comparison sites −0.88 (−1.11 to −0.65) −0.90 (−1.14 to −0.66) −0.75 (−0.99 to −0.52) Reference Reference Reference
Within-Group ChangeComparison Sites as Reference
Unadjusted, β (95% CI)Model 1,a β (95% CI)Model 2,b β (95% CI)Unadjusted, β (95% CI), n = 4425Model 1,a β (95% CI), n = 4147Model 2,b β (95% CI), n = 4147
BMI
HWC −0.39 (−0.53 to −0.25) −0.39 (−0.54 to −0.25) −0.32 (−0.46 to −0.19) −0.18 (−0.31 to −0.05) −0.18 (−0.31 to −0.04) −0.23 (−0.36 to −0.10)
M-HWYC −0.26 (−0.42 to −0.09) −0.26 (−0.42 to −0.09) −0.16 (−0.32 to 0.003) 0.02 (−0.12 to 0.15) 0.02 (−0.12 to 0.16) 0.02 (−0.11 to 0.16)
Comparison sites −0.10 (−0.15 to −0.05) −0.11 (−0.16 to −0.05) 0.07 (0.02 to 0.12) Reference Reference Reference
%BMIp95
HWC −2.24 (−2.87 to −1.60) −2.24 (−2.87 to −1.60) −2.15 (−2.79 to −1.52) −1.01 (−1.60 to −0.43) −1.00 (−1.58 to −0.42) −1.03 (−1.61 to −0.45)
M-HWYC −1.66 (−2.40 to −0.92) −1.66 (−2.40 to −0.92) −1.65 (−2.39 to −0.92) −0.18 (−0.79 to 0.42) −0.17 (−0.78 to 0.44) −0.22 (−0.83 to 0.38)
Comparison sites −0.88 (−1.11 to −0.65) −0.90 (−1.14 to −0.66) −0.75 (−0.99 to −0.52) Reference Reference Reference
a

Adjusted for Hispanic versus non-Hispanic participants (n = 278 missing race and ethnicity).

b

Adjusted for Hispanic versus non-Hispanic participants and BMI at baseline.

#### Stratified BMI Results by Baseline BMI Category

In Table 4, we present the unadjusted and covariate-adjusted BMI changes per year, stratified by baseline BMI category. In fully adjusted models, BMI decreased by −0.28 (95% CI: −0.51 to −0.05) for those with overweight, −0.36 (95% CI: −0.56 to −0.16) for those with obesity, and increased by 0.04 (95% CI: −0.23 to 0.32) for those with severe obesity in the HWC compared with the comparison sites. We saw similar findings for %BMIp95 change for those in the HWC. In the M-HWYC program, BMI-stratified results for change in BMI and %BMIp95 were not statistically significant.

TABLE 4

Unadjusted and Adjusted BMI Changes per Year of Participants in the Clinic and Community Approaches to a Healthy Weight Trial With 12-Month BMI Compared With Subjects From 8 Comparison Sites, by Intervention Assignment, Stratified by Baseline BMI Category

Unadjusted, β (95% CI)Model 1, β (95% CI)Model 2, β (95% CI)
Overweight baseline BMI category
n 1818 1693 1693
BMI
HWC, n = 53 −0.23 (−0.46 to −0.01) −0.25 (−0.48 to −0.02) −0.28 (−0.51 to −0.05)
M-HWYC, n = 53 0.15 (−0.10 to 0.40) 0.14 (−0.11 to 0.39) 0.13 (−0.12 to 0.37)
Comparison sites, n = 1712 Reference Reference Reference
%BMIp95
HWC, n = 53 −1.29 (−2.29 to −0.30) −1.34 (−2.34 to −0.34) −1.35 (−2.35 to −0.35)
M-HWYC, n = 53 0.55 (−0.53 to 1.63) 0.51 (−0.58 to 1.59) 0.50 (−0.59 to 1.58)
Comparison sites, n = 1712 Reference Reference Reference
Obesity baseline BMI category
n 1736 1637 1637
BMI
HWC, n = 81 −0.32 (−0.52 to −0.12) −0.31 (−0.51 to −0.11) −0.36 (−0.56 to −0.16)
M-HWYC, n = 84 −0.08 (−0.29 to 0.13) −0.07 (−0.28 to 0.14) −0.08 (−0.29 to 0.13)
Comparison sites n = 1571 Reference Reference Reference
%BMIp95
HWC, n = 81 −1.54 (−2.42 to −0.66) −1.48 (−2.36 to −0.60) −1.52 (−2.40 to −0.64)
M-HWYC, n = 84 −0.48 (−1.40 to 0.45) −0.43 (−1.36 to 0.50) −0.48 (−1.41 to 0.45)
Comparison sites, n = 1571 Reference Reference Reference
Severe obesity baseline BMI category
n 871 817 817
BMI
HWC, n = 57 0.07 (−0.22 to 0.35) 0.09 (−0.20 to 0.37) 0.04 (−0.23 to 0.32)
M-HWYC, n = 60 0.04 (−0.24 to 0.32) 0.06 (−0.23 to 0.34) 0.07 (−0.20 to 0.35)
Comparison sites, n = 754 Reference Reference Reference
%BMIp95
HWC, n = 57 0.36 (−0.88 to 1.60) 0.43 (−0.80 to 1.66) 0.43 (−0.80 to 1.66)
M-HWYC, n = 60 −0.01 (−1.25 to 1.23) 0.07 (−1.16 to 1.30) 0.06 (−1.16 to 1.29)
Comparison sites, n = 754 Reference Reference Reference
Unadjusted, β (95% CI)Model 1, β (95% CI)Model 2, β (95% CI)
Overweight baseline BMI category
n 1818 1693 1693
BMI
HWC, n = 53 −0.23 (−0.46 to −0.01) −0.25 (−0.48 to −0.02) −0.28 (−0.51 to −0.05)
M-HWYC, n = 53 0.15 (−0.10 to 0.40) 0.14 (−0.11 to 0.39) 0.13 (−0.12 to 0.37)
Comparison sites, n = 1712 Reference Reference Reference
%BMIp95
HWC, n = 53 −1.29 (−2.29 to −0.30) −1.34 (−2.34 to −0.34) −1.35 (−2.35 to −0.35)
M-HWYC, n = 53 0.55 (−0.53 to 1.63) 0.51 (−0.58 to 1.59) 0.50 (−0.59 to 1.58)
Comparison sites, n = 1712 Reference Reference Reference
Obesity baseline BMI category
n 1736 1637 1637
BMI
HWC, n = 81 −0.32 (−0.52 to −0.12) −0.31 (−0.51 to −0.11) −0.36 (−0.56 to −0.16)
M-HWYC, n = 84 −0.08 (−0.29 to 0.13) −0.07 (−0.28 to 0.14) −0.08 (−0.29 to 0.13)
Comparison sites n = 1571 Reference Reference Reference
%BMIp95
HWC, n = 81 −1.54 (−2.42 to −0.66) −1.48 (−2.36 to −0.60) −1.52 (−2.40 to −0.64)
M-HWYC, n = 84 −0.48 (−1.40 to 0.45) −0.43 (−1.36 to 0.50) −0.48 (−1.41 to 0.45)
Comparison sites, n = 1571 Reference Reference Reference
Severe obesity baseline BMI category
n 871 817 817
BMI
HWC, n = 57 0.07 (−0.22 to 0.35) 0.09 (−0.20 to 0.37) 0.04 (−0.23 to 0.32)
M-HWYC, n = 60 0.04 (−0.24 to 0.32) 0.06 (−0.23 to 0.34) 0.07 (−0.20 to 0.35)
Comparison sites, n = 754 Reference Reference Reference
%BMIp95
HWC, n = 57 0.36 (−0.88 to 1.60) 0.43 (−0.80 to 1.66) 0.43 (−0.80 to 1.66)
M-HWYC, n = 60 −0.01 (−1.25 to 1.23) 0.07 (−1.16 to 1.30) 0.06 (−1.16 to 1.29)
Comparison sites, n = 754 Reference Reference Reference

#### Lifestyle Change

In Supplemental Table 5, we outline the changes in lifestyle from baseline to 1 year. For those in the HWC, in fully adjusted models, sugary-beverage intake decreased by −2.59 servings per week (95% CI: −3.68 to −1.50), fast-food intake decreased by −0.61 servings per week (95% CI: −0.91 to −0.31), sleep duration increased by 0.53 hours per day (95% CI: 0.24 to 0.82), screen time decreased by −1.11 hours per day (95% CI: −1.67 to −0.55), and being physically active for ≥60 minutes per day increased by 1.01 days per week (95% CI: 0.56 to 1.46) from baseline to 1 year. For the participants in the M-HWYC intervention, in fully adjusted models, participants decreased their sugary beverages per week (−2.12 servings [95% CI: −3.10 to −1.14]) and increased the frequency of being physically active for ≥60 minutes per day (0.74 days [95% CI: 0.29 to 1.20]).

We found that a PWMI delivered in HWCs resulted in improvements in BMI; %BMIp95 when compared with 8 comparison sites; and sugary-beverage and fast-food intake, sleep, screen time, and physical activity among a predominantly Hispanic and low-income population. We were unable to establish noninferiority in %BMIp95 change for the M-HWYC overall and for those with overweight or obesity, but participants in the M-HWYC did show improvements in sugary-beverage intake and physical activity. When BMI and %BMIp95 results were stratified by weight category, neither intervention was effective in reducing BMI for children with severe obesity.

In the US Preventive Services Task Force evidence report and systematic review, 2 PWMIs reviewed offered 26 to 51 contact hours and reported BMI change.1719  The magnitude of BMI effect in the HWC compared with comparison sites in our study per year was −0.23 (95% CI: −0.36 to −0.10), which was lower but was significant, as compared with the Kalarchian et al20  study in which researchers saw a 12-month BMI change of (SE) −0.61 (0.31) (P = .11) compared with usual care. Our BMI change was more modest than was found by Nemet et al,19  who demonstrated a −1.7 ± 2.3 vs 0.6 ± 0.9 in usual care. However, this study had only 46 children enrolled.19  Compared with our previous HWC intervention, change in %BMIp95 was more robust in this current study in the HWC group and decreased by −1.03 (95% CI: −1.61 to −0.45) compared with our previous finding of a %BMIp95 change of −0.87 (95% CI: −1.82 to 0.09).17  Our estimate was larger than the median changes found in the Pediatric Obesity Weight Evaluation Registry sites for children aged 6 to 11 years, with %BMIp95 of −0.16 (interquartile range, −1.40 to 0.87) at 12 months.21  Finally, any decrease in BMI is likely of clinical benefit, and a strength of our study is that we saw this BMI decrease preserved up to 2 years postintervention.

This study was designed with the hypothesis that the M-HWYC intervention would be noninferior to the HWC in reducing %BMIp95. Our findings did not support this, and there are several potential reasons. First, the M-HWYC was delivered at a different intensity and length compared with the original MEND program. The YMCA has returned to this shorter, more intense model. Second, it is possible that the presence of a pediatric medical provider in the HWC plays a role because past work has revealed that lifestyle change is often improved when supported by a pediatrician.22,23  In addition, both HWCs had access to mental health, which may have improved outcomes. Our clinician champions at the HWCs played a large role in the implementation of the HWC: participated in biweekly technical assistance calls to share lessons learned and adapted the intervention collaboratively. The M-HWYC may have led to other health benefits that were not measured, such as quality of life or other cardiometabolic effects, as have been seen in other successful YMCA programs.24,25  It is also possible that if there had been more engagement in the M-HWYC, we would have seen a BMI effect, as has been shown in previous YMCA interventions.24,25  Finally, the comparison sites sample had a lower baseline BMI and proportion of Hispanic patients served compared with our intervention sites.

There are several reasons why neither intervention was effective in reducing BMI or %BMIp95 for children with severe obesity. First, we may be underpowered for this subgroup. Furthermore, the net daily energy intake decrease necessary for children with severe obesity to achieve a healthy BMI is likely larger than what can be delivered in a primary care–based model.26  Earlier referral to a HWC when a child has a BMI in the overweight or obese range or to a tertiary center for children with severe obesity may be preferable. From our estimates, it appears that children with severe obesity in all 3 groups (HWC, M-HWYC, and comparison sites) had flattening of their BMI, suggesting that they were receiving more weight management care from their pediatrician or elsewhere. Children with severe obesity may need to be in the program longer and receive a higher dose or additional social supports given the higher prevalence among Hispanic and Black populations who suffer from issues associated with racial inequity.27

As with any study, this one is subject to limitations. First, our population was largely Hispanic, and our results may not be generalizable; however, in this study, we appropriately focus on those who are disproportionately affected. Finally, none of our participants met the recommended 26 hours of contact: HWC participants received a mean (SD) of 4.8 (5.7) hours, and the M-HWYC participants received a mean (SD) of 9.9 (12.7) hours. It is possible that if adherence had been higher, effects would have been more robust.28

A comprehensive HWC PWMI that included a pediatric provider, dietitian, and community health worker with text messages and community-resource support resulted in improved BMI and %BMIp95 for a low-income, largely Hispanic population. We were unable to establish noninferiority for the M-HWYC. Obesity is a complex disease that requires investment in high-quality interventions, and the HWC may offer a solution for children disproportionately affected.

We thank the families, institutions, faculty, research staff, and students who participated in the study.

FUNDING: Supported by the Centers for Disease Control and Prevention National Center for Chronic Disease Prevention and Health Promotion (award U18DP006259). Dr Fiechtner is supported by grant K23HD090222 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr Sharifi is supported by grant K08 HS024332 from the Agency for Healthcare Research and Quality. Dr Taveras is supported by grant K24 DK10589 from the National Institute of Diabetes and Digestive and Kidney Diseases. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Centers for Disease Control, Agency for Healthcare Research and Quality, the National Institutes of Health, or any other funders. The funder/sponsor did not participate in the work. Funded by the National Institutes of Health (NIH).

Drs Fiechtner and Taveras conceptualized and designed the study, drafted the initial manuscript, and reviewed and revised the manuscript; Ms Perkins and Ms Price designed the data collection instruments, collected data, and reviewed and revised the manuscript; Ms Luo and Dr Locascio conducted the data analyses and reviewed and revised the manuscript; Drs Sharifi, Gortmaker, and Torres conceptualized and helped design the study and critically reviewed the manuscript for important intellectual content; Drs Langhans, Biggs, and Hohman and Ms Hodge helped with data collection and reviewed and revised the manuscript; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Individual-level data may be shared on request under the conditions that an analysis plan is prepared and approved by the principal investigator or co-investigators, institutional review board approval has been obtained, and all necessary data sharing agreements have been executed. Data can be requested by e-mailing elsie.taveras@mgh.harvard.edu or meperkins@mgh.harvard.edu.

This trial has been registered at www.clinicaltrials.gov (identifier NCT03012126).

%BMIp95

percentage of the 95th percentile

CI

confidence interval

EHR

electronic health record

FQHC

federally qualified health center

HWC

healthy weight clinic

HWYC

MEND

Mind, Exercise, Nutrition…Do it!

M-HWYC

modified Healthy Weight and Your Child

PWMI

pediatric weight management intervention

YMCA

Young Men’s Christian Association

1
Ogden
CL
,
Carroll
MD
,
Kit
BK
,
Flegal
KM
.
Prevalence of childhood and adult obesity in the United States, 2011-2012
.
JAMA
.
2014
;
311
(
8
):
806
814
2
Hales
CM
,
Carroll
MD
,
Fryar
CD
,
Ogden
CL
.
Prevalence of obesity among adults and youth: United States, 2015-2016
.
NCHS Data Brief
.
2017
;(
288
):
1
8
3
Grossman
DC
,
Bibbins-Domingo
K
,
Curry
SJ
, et al;
.
Screening for obesity in children and adolescents: US Preventive Services Task Force recommendation statement
.
JAMA
.
2017
;
317
(
23
):
2417
2426
4
Anand
SG
,
WG
,
Zuckerman
BS
.
Specialized care of overweight children in community health centers
.
Health Aff (Millwood)
.
2010
;
29
(
4
):
712
717
5
Cheng
JK
,
Wen
X
,
Coletti
KD
,
Cox
JE
,
Taveras
EM
.
2-Year BMI changes of children referred for multidisciplinary weight management
.
Int J Pediatr
.
2014
;
2014
:
152586
6
Sacher
PM
,
Kolotourou
M
,
PM
, et al
.
Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity
.
Obesity (Silver Spring)
.
2010
;
18
(
suppl 1
):
S62
S68
7
Fagg
J
,
P
,
Cole
TJ
, et al
.
From trial to population: a study of a family-based community intervention for childhood overweight implemented at scale
.
Int J Obes
.
2014
;
38
(
10
):
1343
1349
8
Kolotourou
M
,
D
,
Gammon
C
,
Smith
L
,
P
,
Sacher
PM
.
Long-term outcomes following the MEND 7-13 Child Weight Management Program
.
Child Obes
.
2015
;
11
(
3
):
325
330
9
Fiechtner
L
,
Perkins
M
,
Biggs
V
, et al
.
Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial
.
Contemp Clin Trials
.
2018
;
67
:
16
22
10
Rowlands
AV
,
Rennie
K
,
Kozarski
R
, et al
.
Children’s physical activity assessed with wrist- and hip-worn accelerometers
.
Med Sci Sports Exerc
.
2014
;
46
(
12
):
2308
2316
11
A
,
Acebo
C
.
The role of actigraphy in sleep medicine
.
Sleep Med Rev
.
2002
;
6
(
2
):
113
124
12
Hoelscher
DM
,
Day
RS
,
Lee
ES
, et al
.
Measuring the prevalence of overweight in Texas schoolchildren
.
Am J Public Health
.
2004
;
94
(
6
):
1002
1008
13
Hoelscher
DM
,
Day
RS
,
Kelder
SH
,
Ward
JL
.
Reproducibility and validity of the secondary level School-Based Nutrition Monitoring student questionnaire
.
J Am Diet Assoc
.
2003
;
103
(
2
):
186
194
14
Thiagarajah
K
,
Fly
,
Hoelscher
DM
, et al
.
Validating the food behavior questions from the elementary school SPAN questionnaire
.
J Nutr Educ Behav
.
2008
;
40
(
5
):
305
310
15
Pereira
MA
,
Kartashov
AI
,
Ebbeling
CB
, et al
.
Fast-food habits, weight gain, and insulin resistance (the CARDIA study): 15-year prospective analysis
.
Lancet
.
2005
;
365
(
9453
):
36
42
16
Taveras
EM
,
Berkey
CS
,
Rifas-Shiman
SL
, et al
.
Association of consumption of fried food away from home with body mass index and diet quality in older children and adolescents
.
Pediatrics
.
2005
;
116
(
4
):
e518
e524
17
Taveras
EM
,
Perkins
M
,
Anand
S
, et al
.
Clinical effectiveness of the massachusetts childhood obesity research demonstration initiative among low-income children
.
Obesity (Silver Spring)
.
2017
;
25
(
7
):
1159
1166
18
O’Connor
EA
,
Evans
CV
,
Burda
BU
,
Walsh
ES
,
Eder
M
,
Lozano
P
.
Screening for obesity and intervention for weight management in children and adolescents evidence report and systematic review for the US Preventive Services Task Force
.
JAMA
.
2017
;
317
(
23
):
2427
2444
19
Nemet
D
,
Barkan
S
,
Epstein
Y
,
Friedland
O
,
Kowen
G
,
Eliakim
A
.
Short- and long-term beneficial effects of a combined dietary-behavioral-physical activity intervention for the treatment of childhood obesity
.
Pediatrics
.
2005
;
115
(
4
).
20
Kalarchian
MA
,
Levine
MD
,
Arslanian
SA
, et al
.
Family-based treatment of severe pediatric obesity: randomized, controlled trial
.
Pediatrics
.
2009
;
124
(
4
):
1060
1068
21
Kumar
S
,
King
EC
,
Christison
AL
, et al;
POWER Work Group
.
Health outcomes of youth in clinical pediatric weight management programs in POWER
.
J Pediatr
.
2019
;
208
:
57
65.e4
22
Sharifi
M
,
Marshall
G
,
Goldman
RE
,
Cunningham
C
,
Marshall
R
,
Taveras
EM
.
Engaging children in the development of obesity interventions: exploring outcomes that matter most among obesity positive outliers
.
Patient Educ Couns
.
2015
;
98
(
11
):
1393
1401
23
Sharifi
M
,
Marshall
G
,
Goldman
R
, et al
.
Exploring innovative approaches and patient-centered outcomes from positive outliers in childhood obesity
.
.
2014
;
14
(
6
):
646
655
24
Trost
SG
,
Sundal
D
,
Foster
GD
,
Lent
MR
,
Vojta
D
.
Effects of a pediatric weight management program with and without active video games a randomized trial
.
JAMA Pediatr
.
2014
;
168
(
5
):
407
413
25
Foster
GD
,
Sundal
D
,
McDermott
C
,
Jelalian
E
,
Lent
MR
,
Vojta
D
.
Feasibility and preliminary outcomes of a scalable, community-based treatment of childhood obesity
.
Pediatrics
.
2012
;
130
(
4
):
652
659
26
Dietz
WH
.
Are we making progress in the prevention and control of childhood obesity? It all depends on how you look at it
.
Obesity (Silver Spring)
.
2016
;
24
(
5
):
991
992
27
Skinner
AC
,
Ravanbakht
SN
,
Skelton
JA
,
Perrin
EM
,
Armstrong
SC
.
Prevalence of obesity and severe obesity in US children, 1999-2016
.
Pediatrics
.
2018
;
141
(
3
):
e20173459
28
Atkins
M
,
Castro
I
,
Sharifi
M
, et al
.
Unmet social needs and adherence to pediatric weight management interventions: Massachusetts, 2017-2019
.
Am J Public Health
.
2020
;
110
(
S2
):
S251
S257

## Competing Interests

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.