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/m) consumed a very-low-carbohydrate (VLC) diet, with home delivery of prepared meals, at an energy level to promote 15 ± 3% weight loss.
Background A 2018 American Heart Association science advisory indicated that, pending further research, artificially sweetened beverages (ASBs) may be an appropriate initial replacement for sugar-sweetened beverages (SSBs) during transition to unsweetened beverages (USBs). Methods and Results We randomly assigned 203 adults (121 males, 82 females; 91.6% retention), who habitually consumed SSBs, to 3 groups and delivered free SSBs, ASBs, or USBs to their homes for 12 months.
View Article and Find Full Text PDFObjective: To determine the effects of diets varying in carbohydrate to fat ratio on total energy expenditure.
Design: Randomized trial.
Setting: Multicenter collaboration at US two sites, August 2014 to May 2017.
Background: Less than 45% of U.S. children meet the 60 min·d(-1) physical activity (PA) guideline.
View Article and Find Full Text PDFBackground: One of the most difficult aspects of conducting clinical research is the ability to successfully recruit participants. Pediatric clinical research presents unique recruitment challenges that relate to the need for parental consent on behalf of a minor, child assent, and school attendance. Yet, this has been less well studied.
View Article and Find Full Text PDFBackground: Omega-3 fatty acids supplements lower triglyceride (TG) levels in adults; little pediatric information is available. We evaluated their effect in hypertriglyceridemic adolescents.
Methods: Twenty-five patients aged 10 to 19 years with TG levels 150 to 1000 mg/dL were randomized to 6 months double-blind trial of Lovaza (~3360 mg docosahexaenoic acid + eicosapentaenoic acid per day) versus placebo.
Objective: Determine if adolescent immunization rates can be improved by contacting the parents or by contacting both the parents and adolescents.
Methods: Thirteen- to 17-year-olds overdue for at least 1 of 3 immunizations were randomized to (1) a control arm (Control), (2) telephone calls to the parent/guardian (Parent Only), or (3) telephone calls to the parent/guardian and the adolescent (Parent/Adol). Immunization records were assessed 4 weeks and 1 year after the intervention.