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. Results: Opt-in strategies yielded a significantly lower overall recruitment rate among preschoolers compared with school-age children. Among preschoolers, an opt-out strategy demonstrated a significantly higher overall recruitment rate compared with an opt-in strategy with the main advantage in the number of families initially contacted. Conclusions: Opt-out recruitment strategies may be more effective in overcoming the barriers of recruitment in the preschool age-group because it does not rely on parent recognition of obesity.

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. Assessments were conducted at baseline, Month 6 (posttreatment), and Month 12 (6-month follow-up). RESULTS: LAUNCH-HV demonstrated a significantly greater decrease on the primary outcome of change in BMI z-score (BMIz) pre- to posttreatment compared with PC (p = .007), whereas LAUNCH-clinic was not significantly different from PC (p = .08). Similar results were found for secondary outcomes. CONCLUSIONS: LAUNCH-HV, but not LAUNCH-clinic, significantly reduced BMIz compared with PC by posttreatment, indicating the need for intensive behavioral intervention, including home visitation, to address weight management in obese preschool children.