Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Bidirectional Associations between Restrained Eating and Body Mass Index in Middle Childhood

The nature of the association between dietary restraint and weight has been examined in adult samples, but much less is known about this relationship among children. The current study examined the transactional associations among restrained eating behavior and weight among boys and girls during middle childhood. Data for this study came from 263 children participating in the Families and Schools for Health Project (FiSH), a longitudinal study of the psychosocial correlates of childhood obesity. Participants were interviewed by trained researchers in their third- and fourth-grade year when they completed questionnaires and anthropometric assessments. Dietary restraint was assessed using the restrained eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ), and weight was assessed using Body Mass Index z-scores (BMIz). Bidirectional associations between variables were examined using cross-lagged models controlling for children’s sex, ethnicity, and weight in first grade. Results indicated that weight in grade 3 was related to greater dietary restraint in grade 4 (B = 0.20, p = 0.001), but dietary restraint in grade 3 was not associated with weight in grade 4 (B = 0.01, p = 0.64). Neither child sex nor race/ethnicity were associated with BMIz or dietary restraint at either time point. Findings from this study advance the existing limited understanding of eating behavior development among children and show that weight predicts increases in children’s dietary restraint in middle childhood

Longitudinal Associations between Emotion Regulation and Adiposity in Late Adolescence: Indirect Effects through Eating Behaviors

The prevalence of obesity among U.S. youth continues to increase, with many adolescents engaging in unhealthy eating behaviors. Increasingly, research points to the role of self-regulation in obesity development, yet existing work has largely focused on young children and/or clinical adult populations. This multi-method longitudinal study (N = 153) utilized a path analysis to delineate links between emotion regulation (age 15), emotional eating and dietary restraint (age 16), and adiposity (% body fat) using a BodPod for body composition assessment (age 19). Emotion regulation was negatively associated with emotional eating (β = −0.30, p < 0.001) and positively associated with dietary restraint (β = 0.15, p < 0.05) at age 16, but was not associated with age 19 adiposity (β = −0.01, p = ns). Emotional eating was positively associated with adiposity (β = 0.24, p < 0.01). Indirect effects suggested that emotional eating, but not dietary restraint, at age 16 serves as a mechanism that helps explain the associations between emotion regulation and adiposity four years later. Results from this study suggest that both emotion regulation and emotional eating represent promising targets for that should be included in future interventions aimed at preventing adolescent obesity

Associations between eating behaviors, diet quality and body mass index among adolescents

OBJECTIVE: Some eating behaviors are associated with negative nutrition-related outcomes in adults, but research is lacking in adolescent samples. The current study examined whether dietary restraint moderates the relationship between disinhibition and weight outcomes and overall diet quality in a community sample of 16-year old adolescents. METHODS: Participants were recruited from a longitudinal study examining self-regulation and cardiometabolic risk. Data for this cross-sectional study were collected from questionnaires and laboratory visits when participants were approximately 16 years old (n = 178). Disinhibition and restraint were assessed using two subscales of the Three-Factor Eating Questionnaire. Diet quality was determined using Healthy Eating Index-2010 (HEI-2010) scores that were calculated using dietary data from 24-h dietary recalls. Two separate hierarchical linear regression analyses tested whether restraint moderated the associations of disinhibition with BMI-for-age percentile and HEI-2010 scores. RESULTS: After adjusting for covariates, restraint moderated the association between disinhibition and HEI-2010 scores (β = -0.21, p = 0.03). There was a main effect for disinhibition on BMI-for-age percentiles (β = 0.58, p = 0.02), but this relationship was not moderated by the level of restraint. CONCLUSIONS: The relationship between disinhibition and overall diet quality differed among adolescents according to level of dietary restraint. Although disinhibition independently predicted weight status, the level of restraint had no influence on this association. Future studies should examine restraint in relation to energy intake and weight concerns to better understand how it influences weight and dietary outcomes in this population