Embedding weight management into safety-net pediatric primary care: randomized controlled trial

Abstract

Background: Implementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States).

Methods: In a 12-month trial, families of children (age 7-12 years; body mass index ≥85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n = 360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions.

Results: The mean body mass index Z-score declined in both arms (P < 0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P = 0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P = 0.05), low-density lipoprotein cholesterol (P = 0.04), aspartate aminotransferase (P = 0.02), and alanine transaminase (P = 0.03) concentrations.

Conclusions: Safety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters.

Trial registration: ClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.

Keywords: Family-based intervention; Safety net care; Weight management.

Fig. 1

CONSORT (CONsolidated Standards Of Reporting Trials) Flow Diagram

Fig. 2

Change in body mass index Z-score by randomization group. Change in body mass index (BMI) Z-score by randomization group from baseline to 12-months (n = 182 in Standard Care Alone (control) intervention; n = 178 in Standard Care + Enhanced Program (experimental) intervention. The rate of change in the mean BMI Z-score decreased 0.12 (SE: 0.03) units in the control intervention vs. 0.15 (SE: 0.03) in the experimental intervention (<0.01) per 12-months for both interventions with no significant difference observed between the groups (P = 0.15)