Related Experiment Video
Updated: Mar 19, 2026
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Barriers to Recruitment in Pediatric Obesity Trials: Comparing Opt-in and Opt-out Recruitment Approaches
Mary Beth McCullough1, David Janicke2, Cathleen Odar Stough1
1Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Insights
Opt-out recruitment is more effective for preschool obesity trials than opt-in. This method increases participation by not requiring parents to recognize their child
Area of Science:
- Pediatric Health
- Clinical Trial Recruitment
- Obesity Research
Background:
- Pediatric weight management clinical trials face recruitment challenges.
- Effective recruitment strategies are crucial for trial success and generalizability.
- Understanding recruitment method efficacy is vital for optimizing trial participation.
Purpose of the Study:
- To compare the effectiveness of opt-in versus opt-out recruitment strategies in pediatric weight management clinical trials.
- To evaluate recruitment rates across different age groups (preschoolers vs. school-age children).
Main Methods:
- Two randomized controlled trials (RCTs) for childhood obesity were analyzed.
- Opt-in recruitment (parents initiate contact) was compared with opt-out recruitment (parents decline participation).
- Recruitment rates were assessed for preschoolers and school-age children.
Main Results:
- Opt-in strategies showed lower recruitment rates in preschoolers compared to school-age children.
- For preschoolers, opt-out recruitment significantly increased overall recruitment rates compared to opt-in.
- Opt-out strategies improved initial family contact rates in preschool trials.
Conclusions:
- Opt-out recruitment may be more successful for preschool-aged children in obesity trials.
- This method may circumvent barriers related to parental recognition of childhood obesity.
- Implementing opt-out strategies could enhance participation in pediatric obesity research.
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.
Related Concept Videos
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
01:25Pharmacokinetics in Obese Patients: Drug Absorption and Distribution
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
01:11Clinical Trials: Overview
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...