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
BACKGROUND: The need for coronavirus 2019 (COVID-19) vaccination in different age groups and populations is a subject of great uncertainty and an ongoing global debate. Critical knowledge gaps regarding COVID-19 vaccination include the duration of protection offered by different priming and booster vaccination regimens in different populations, including homologous or heterologous schedules; how vaccination impacts key elements of the immune system; how this is modified by prior or subsequent exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and future variants; and how immune responses correlate with protection against infection and disease, including antibodies and effector and T cell central memory. METHODS: The Platform Trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, multi-arm, Bayesian, adaptive, randomised controlled platform trial. PICOBOO will expeditiously generate and translate high-quality evidence of the immunogenicity, reactogenicity and cross-protection of different COVID-19 priming and booster vaccination strategies against SARS-CoV-2 and its variants/subvariants, specific to the Australian context. While the platform is designed to be vaccine agnostic, participants will be randomised to one of three vaccines at trial commencement, including Pfizer's Comirnaty, Moderna's Spikevax or Novavax's Nuvaxovid COVID-19 vaccine. The protocol structure specifying PICOBOO is modular and hierarchical. Here, we describe the Core Protocol, which outlines the trial processes applicable to all study participants included in the platform trial. DISCUSSION: PICOBOO is the first adaptive platform trial evaluating different COVID-19 priming and booster vaccination strategies in Australia, and one of the few established internationally, that is designed to generate high-quality evidence to inform immunisation practice and policy. The modular, hierarchical protocol structure is intended to standardise outcomes, endpoints, data collection and other study processes for nested substudies included in the trial platform and to minimise duplication. It is anticipated that this flexible trial structure will enable investigators to respond with agility to new research questions as they arise, such as the utility of new vaccines (such as bivalent, or SARS-CoV-2 variant-specific vaccines) as they become available for use. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12622000238774. Registered on 10 February 2022.