Barriers to Recruitment in Pediatric Obesity Trials: Comparing Opt-in and Opt-out Recruitment Approaches.

Objective: To compare the efficacy of opt-in versus opt-out recruitment methods in pediatric weight management clinical trials.

Methods: Recruitment of preschoolers and school-age children across two obesity randomized controlled trials (RCTs) were compared using the same opt-in recruitment approach (parents contact researchers in response to mailings). Opt-in and opt-out strategies (parents send decline postcard in response to mailings if they do not want to participate) were then compared across two preschool obesity RCTs.

A pilot randomized controlled trial of a behavioral family-based intervention with and without home visits to decrease obesity in preschoolers.

Objective: Tested two family-based behavioral treatments for obesity in preschool children, one meeting the Expert Committee guidelines for Stage 3 obesity intervention criteria (LAUNCH-clinic) and one exceeding Stage 3 (LAUNCH with home visit [LAUNCH-HV]), compared with a Stage 1 intervention, pediatrician counseling (PC).

Methods: In all, 42 children aged 2-5 years with a body mass index (BMI) percentile of ≥95th were randomized. A total of 33 met intent-to-treat criteria.