Design and conduct of a randomized controlled feeding trial in a residential setting with mitigation for COVID-19.

BACKGROUND: Evaluating effects of different macronutrient diets in randomized trials requires well defined infrastructure and rigorous methods to ensure intervention fidelity and adherence. METHODS: This controlled feeding study comprised two phases. During a Run-in phase (14-15 weeks), study participants (18-50 years, BMI, ≥27 kg/m2) consumed a very-low-carbohydrate (VLC) diet, with home delivery of prepared meals, at an energy level to promote 15 ± 3% weight loss. During a Residential phase (13 weeks), participants resided at a conference center. They received a eucaloric VLC diet for three weeks and then were randomized to isocaloric test diets for 10 weeks: VLC (5% energy from carbohydrate, 77% from fat), high-carbohydrate (HC)-Starch (57%, 25%; including 20% energy from refined grains), or HC-Sugar (57%, 25%; including 20% sugar). Outcomes included measures of body composition and energy expenditure, chronic disease risk factors, and variables pertaining to physiological mechanisms. Six cores provided infrastructure for implementing standardized protocols: Recruitment, Diet and Meal Production, Participant Support, Assessments, Regulatory Affairs and Data Management, and Statistics. The first participants were enrolled in May 2018. Participants residing at the conference center at the start of the COVID-19 pandemic completed the study, with each core implementing mitigation plans. RESULTS: Before early shutdown, 77 participants were randomized, and 70 completed the trial (65% of planned completion). Process measures indicated integrity to protocols for weighing menu items, within narrow tolerance limits, and participant adherence, assessed by direct observation and continuous glucose monitoring. CONCLUSION: Available data will inform future research, albeit with less statistical power than originally planned.

A systematic review of smartphone applications for smoking cessation.

Tobacco use is the leading cause of preventable disease and death in the USA. However, limited data exists regarding smoking cessation mobile app quality and intervention effectiveness. Innovative and scalable interventions are needed to further alleviate the public health implications of tobacco addiction. The proliferation of the smartphone and the advent of mobile phone health interventions have made treatment more accessible than ever. The purpose of this review was to examine the relation between published scientific literature and available commercial smartphone health apps for smoking cessation to identify the percentage of scientifically supported apps that were commercially available to consumers and to determine how many of the top commercially available apps for smoking cessation were supported by the published scientific literature. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, apps were reviewed in four phases: (1) identified apps from the scientific literature, (2) searched app stores for apps identified in the literature, (3) identified top apps available in leading app stores, and (4) determined which top apps available in stores had scientific support. Seven articles identified six apps with some level of scientific support, three (50%) were available in at least one app store. Conversely, among the top 50 apps suggested by each of the leading app stores, only two (4%) had any scientific support. While half of the scientifically vetted apps remain available to consumers, they are difficult to find among the many apps that are identified through app store searches.