Challenges and opportunities of recruiting a very large sample of pregnant people for an online nationwide randomized controlled trial (Preprint)
Authors: Laird Breanne , Moyer Sara , Huberty Jennifer , Kinser Patricia 
Published: February 2025

BACKGROUND

It is challenging to recruit vulnerable populations such as pregnant individuals, particularly during the perinatal period which involves significant life changes and stressful situations that create barriers to participation. Barriers to participation are even more prominent in historically marginalized populations, such as minoritized and low-income populations. Current literature is limited on what general recruitment methods (i.e., in-person, online, active, passive) and associated specific recruitment methods for each strategy are best to recruit diverse groups of pregnant people into online studies for the promotion of perinatal mental health.

OBJECTIVE

Describe recruitment methods and strategies used to recruit a large sample of diverse pregnant individuals to an online nationwide large-scale randomized controlled trial.

METHODS

The Mamma Mia study is a multi-site randomized controlled trial of an online- and mobile-based intervention for preventing and reducing perinatal depressive symptoms. The Mamma Mia study protocol and methods were published elsewhere. Preparation for recruitment began in the spring of 2020 (Y1 Q), and we began recruitment on October 15th, 2020 (Year 1 Q3). Recruitment was completed September 1st, 2023 (Year 4 Q2). Our recruitment benchmarks included Year 1, Q3-4 n= 162; Year 2, Q1-2 n=366; Year 2, Q3-4 n= 366; Year 3, Q1-2 n=366; Year 3, Q3-4 n= 366; Year 4, Q1-2 n=324; Year 4, Q3-4 enrollment complete. The study intended to ensure a diverse representation in the study population, with internal team demographic goals of at least 50% of participants who identified as non-White and at least 25% low-income (as defined as a household income of less than $50,000).

RESULTS

A total study sample of n=1953 pregnant individuals from across the U.S. The study sample included participants who self-identified as African American/Black (18.8%, n=367), Asian/Pacific Islander (4.9%, n=95), Native American/Alaska Native (0.7%, n=14), Caucasian/White (64.3%, n=1255), Other (3.1%, n=61), and Latino/Hispanic (8.1%, n=158). The total sample consisted of 64.3% Caucasian/White participants (n=1255) and 35.7% non-White participants (n=698).

CONCLUSIONS

Combining local and in-person with national and online recruitment methods allowed for successful recruitment of a large sample of pregnant individuals. Additionally this layered approach allowed the study to continue during an unplanned world event and be responsive to pivoting to meet recruitment goals. Recruitment approaches and methods that were the most successful were establishing community partnerships both online nationally and in-person locally, dedicated research time to focus on recruiting historically marginalized groups for a more representative sample, allocation of study time and resources to recruitment preparation, and dedicated internal research team recruitment planning and tracking.

CLINICALTRIAL

HM20017197