ABSTRACT
Introduction: Overweight and obesity in youth with serious emotional disturbance (SED) is exceedingly common. In 2015 the AHA called attention to mental illnesses in youth as important risk conditions for early CVD and the need for transformational change in management of overweight and obesity in this group. Our objective was to test a 12-month, innovative healthy weight intervention in youth with SED.Hypothesis: The active intervention is more effective than control in decreasing BMI Z-score compared at 12 m. Method(s): We conducted a two-arm randomized trial in 2 outpatient pediatric mental health settings in 112 youth, ages 8-18 yrs. The active intervention group was offered 12m of in-person and virtual individual weight management sessions led by health coaches who provided guidance on improving diet and increasing physical activity, and engaged parents. Result(s): At baseline, mean (SD) age was 13.0 (2.7) yrs with 46% ages 8-12 and 54% 13-18;55% were male, 46% Black, 39% had household income less than $50K/yr and 31% lived in a single-parent household. Primary diagnoses were ADHD (41%), major depression (23%), and anxiety (23%). Mean BMI Z-score (SD) was 2.0(0.4), BMI 30.4 (6.4) kg/m2.Mean(SD) psychotropic medications were 2.1(1.4).At 12m, 111 (99%) had a follow-up weight;42 were collected after the onset of the COVID pandemic). The intervention group compared to the control group had 0.15 decrease in BMI Z-Score (95% CI 0.26 to 0.04), p<0.007) between baseline and 12 m (Figure) and a 1.43 kg/m2 decrease in BMI (95% CI 2.43, 0.42, p<0.006). Estimated net effect on BMI Z-score for intervention vs. control was enhanced during the pandemic but not statistically different from net effects pre-pandemic (p=0.06). Conclusion(s): A weight control intervention designed for children with SED decreased BMI Z-score substantially over 12 months, including during the COVID-19 pandemic. These results provide empirical evidence in support of weight control programs in a population at high risk for early development of CVD risk factors.
ABSTRACT
Objectives: The objective of this presentation is to test the efficacy and safety of 2 doses of suramin vs placebo in children aged 4 to 17 years with autism spectrum disorder (ASD). The hypotheses are that at least 1 of 2 suramin doses would show improvement in the Aberrant Behavior Checklist (ABC) Core score and that treatment would be safe and tolerable. Methods: Fifty-two boys were enrolled in 3 treatment arms: 10 mg/kg and 20 mg/kg, and placebo dosed at baseline, at weeks 4 and 8. Subjects were diagnosed by DSM-5 criteria and severity measured by the Autism Diagnostic Observation Schedule. The main efficacy analyses were ABC Core (subscales 2, 3, and 5) and Clinical Global Impression–Improvement (CGI-I) scale. Question 1 was assessed using intent-to-treat sample change scores from baseline to endpoint using ANOVA. Although the study was not designed for formal statistical comparison, ABC Core and CGI-I were tested at a family-wise Type I level of 0.05 using Dunnett’s p value for multiple comparisons. The study was approved by the South Africa Health Products Regulatory Authority and each site’s IRB. Results: The study was conducted at 6 sites in South Africa. The sample was multiracial with a mean age of approximately 8 years and a range of 4 to 15 years. There was a wide variability in the severity of ASD symptoms at baseline. Forty-four subjects completed the study, and there were 8 early withdrawals (COVID-19: 5;serious adverse event [SAE]: 1;other reason: 2). The 10 mg arm showed a sustained benefit across time points. The ABC Core modeling mean ± standard error (SE) of 10 mg showed a greater numeric improvement (–12.5 ± 3.18) vs placebo (–8.9 ± 2.86) (nonsignificant) at Week 14. The 20 mg arm did not show improvement vs placebo at Week 14. In exploratory analyses, the 10 mg arm showed greater differences from placebo in ABC Core in younger and less severe subjects. CGI-I modeled mean ± SE changes from baseline were 2.8 ± 0.30 (p = 0.016) in the 10 mg arm and 2.0 ± 0.28 (p = 0.65) in the 20 mg arm vs 1.7 ± 0.27 in the placebo. Suramin was generally safe and well tolerated over 14 weeks. There was 1 SAE, status epilepticus, in a subject (20-mg arm) with multiple risk factors for seizure;it resolved without sequelae. Conclusions: This dose-ranging proof-of-concept study showed some positive results from a treatment with a novel mechanism of action. Limitations include the small sample size and exploratory analyses that require confirmation in a larger study. Suramin was safe and tolerable over 14 weeks.