Active vs Traditional Methods of Recruiting Children for a Clinical Trial in Rural Primary Care Clinics: A Cluster-Randomized Clinical Trial.

Importance: To our knowledge, there are no published randomized clinical trials of recruitment strategies. Rigorously evaluated successful recruitment strategies for children are needed. Objective: To evaluate the feasibility of 2 recruitment methods for enrolling rural children through primary care clinics to assess whether either or both methods are sufficiently effective for enrolling participants into a clinical trial of a behavioral telehealth intervention for children with overweight or obesity. Design, Setting, and Participants: This cluster-randomized clinical trial of 2 recruitment methods was conducted at 4 primary care clinics in 4 separate states. Each clinic used both recruitment methods in random order. Clinic eligibility criteria included at least 40% pediatric patients with Medicaid coverage and at least 100 potential participants. Eligibility criteria for children included a rural home address, age 6 to 11 years, and body mass index at or above the 85th percentile. Recruitment began February 3, 2020, and randomization of participants occurred on August 17, 2020. Data were analyzed from October 3, 2021, to April 21, 2022. Interventions: Two recruitment methods were assessed: the active method, for which a list of potential participants seen within the past year at each clinic was generated through the electronic health record and consecutively approached by research staff based on visit date to the clinic, and the traditional method, for which recruitment included posters, flyers, social media, and press release. Clinics were randomized to the order in which the 2 methods were implemented in 4-week periods, followed by a 4-week catch-up period using the method found most effective in previous periods. Main Outcomes and Measures: For each recruitment method, the number and proportion of randomized children among those who were approached was calculated. Results: A total of 104 participants were randomized (58 girls [55.8%]; mean age, 9.3 [95% CI, 9.0-9.6] years). Using the active method, 535 child-parent dyads were approached and 99 (18.5% [95% CI, 15.3%-22.1%]) were randomized. Using the traditional method, 23 caregivers expressed interest, and 5 (21.7% [95% CI, 7.5%-43.7%]) were randomized. All sites reached full enrollment using the active method and no sites achieved full enrollment using the traditional method. Mean time to full enrollment was 26.3 (range, 21.0-31.0) days. Conclusions and Relevance: This study supports the use of the active approach with local primary care clinics to recruit children with overweight and obesity from rural communities into clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT04142034.

Sleep apnoea and visceral adiposity in middle-aged male and female subjects.

In obese male subjects, visceral adiposity has been associated with obstructive sleep apnoea (OSA), while studies in overweight males and females are limited. Our goal was to examine the association between OSA and visceral fat in a relatively nonobese population and assess the effects of 2 months placebo-controlled continuous positive airway pressure (CPAP) use on abdominal fat. 81 subjects, 22 middle-aged males and 20 post-menopausal females with OSA, and 19 male and 20 female controls were studied in the sleep laboratory for four nights. Abdominal (visceral (VAT) and subcutaneous (SAT) adipose tissue) and liver fat were assessed with computed tomography. OSA patients were re-assessed post-CPAP and post sham-CPAP. Apnoeic males had significantly higher VAT than controls, while apnoeic females had higher SAT than controls. In both sexes, OSA was associated with increased liver fat. In males, apnoea was associated with VAT whereas in females it was associated with subcutaneous, visceral and total fat. CPAP did not affect abdominal and liver fat. In overweight males, visceral adiposity is associated with OSA whereas in females it is associated with global adiposity. In overweight males, our therapeutic goal should be the reduction of visceral adiposity and its metabolic correlates, whereas, in females, weight loss may be sufficient. Short-term CPAP treatment does not affect general, abdominal or intra-hepatic adiposity.

A critical examination of the sensitivity of unidimensional subscales derived from the Hamilton Depression Rating Scale to antidepressant drug effects.

Unidimensional subscales for assessment of major depression may be more sensitive to antidepressant drug effects than the Hamilton Depression Rating Scale (HAM-D). To further examine this possibility, we analyzed pooled data from eight comparable, well-controlled clinical trials of venlafaxine and compared such subscales and the 17-item HAM-D (HAM-D(17)) based on effect size and number of patients required for 80% power. Symptoms of depression were assessed using the HAM-D among intent-to-treat patients (2045) randomly assigned to receive venlafaxine (immediate release, n = 474; extended release, n = 377), one of several selective serotonin reuptake inhibitors (SSRIs) (n = 748), or placebo (n = 446) for up to 8 weeks. With SSRIs or venlafaxine vs. placebo, subscales yielded effect sizes (0.328-0.528) 16 to 76% larger than the HAM-D(17) did (0.237 and 0.396, respectively), and required 31 to 64% fewer patients for 80% power. With venlafaxine vs. SSRIs, the subscales showed no advantage over the HAM-D(17); all devices yielded comparable, positive effect sizes (0.183-0.195). Final subscale scores significantly predicted (all P < 0.05) whether patients met criteria for remission (eg, HAM-D(17) score of < or = 7). These findings suggest that unidimensional subscales are more sensitive to antidepressant drug effects than the HAM-D(17) is, but only in active agent/placebo comparisons. Our data further suggest the subscales can predict the presence of remission. Given these findings, prudent use of these subscales may be appropriate, cost-effective, and informative.