Strategies and Challenges in Recruiting Pregnant Women with Elevated Body Mass Index for a Behavioral Lifestyle Intervention

Abstract

Purpose: Pregnant women with elevated body mass index (BMI) are difficult to recruit into lifestyle studies. This article (1) summarized strategies to recruit pregnant women into a randomized trial, and (2) reported recruitment statistics and their correlates. Materials and Methods: African American and white women with BMI ≥25 and gestational age <16 weeks were recruited primarily through obstetric clinics into the Health in Pregnancy and Postpartum study. Women completed a brief screening form, and if initially eligible, a phone screening. We compared characteristics of those randomized versus not randomized. Results: Initially eligible pregnant women ( N = 1578) were identified through direct recruitment by research staff, indirect recruitment by clinic staff at obstetric clinics, and self-referrals through advertisements. Of these women, 54.0% (850) were reached for further screening, and 43.5% (685) were fully eligible. Among eligible women, 58.8% (403) were scheduled for a baseline visit, and 33.3% (228) were randomized. The overall recruitment yield was 14.4%. Recruited participants were diverse (44% African Americans) and averaged 12.6 weeks gestation at baseline. Randomized (vs. nonrandomized) women were more likely to own a cell phone, have access to a computer with internet at home or work, and have downloaded a podcast. Conclusions: Although this study did not reach the recruitment goal, a relatively large and diverse sample of pregnant women were recruited early in pregnancy. Recruiting women with elevated BMI for a behavioral lifestyle intervention is challenging, particularly among women with characteristics, including less phone and internet access and limited experience in using podcasts. This study is registered at NCT02260518.

Process evaluation methods and results from the Health in Pregnancy and Postpartum (HIPP) randomized controlled trial

“…The aim of the Health In Pregnancy and Postpartum (HIPP) study, a randomized clinical trial, was to evaluate the impact of a lifestyle intervention (versus standard care) on gestational weight gain (primary outcome) and related outcomes in African American and white women who enter pregnancy living with overweight or obesity [ 13 ]. In earlier papers, we described the study design and methods, including the intervention [ 13 ], as well as recruitment strategies and yields [ 14 ] and the impact of the intervention on gestational weight gain [ 15 ] and postpartum weight retention [ 16 ]. In our two outcome papers [ 15 , 16 ], we reported associations between receipt of counseling calls and gestational weight gain / postpartum weight retention.…”

“…A detailed description of the HIPP study design and methods is available elsewhere [ 13 ]. Participants (N = 219), recruited largely via obstetric and gynecology clinics in South Carolina [ 14 ], were randomized to either a behavioral lifestyle intervention (n = 112) or a standard care condition (n = 107). Measurement staff were blind to randomization assignment.…”

Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight

“…First, our findings may not be generalizable to women with normal weight, women from different racial/ethnic backgrounds, or women whose first prenatal care visit is later than 16 weeks. Similar to other lifestyle intervention programs (36), a low proportion of women who were initially eligible were randomized (37). This indicates the challenges of recruiting pregnant women in early pregnancy (such as pregnancy‐related discomfort, fatigue, or nausea) or the disinterest in enrolling into an intervention, which involves long follow‐up and needs time commitment, etc.…”

“…This indicates the challenges of recruiting pregnant women in early pregnancy (such as pregnancy‐related discomfort, fatigue, or nausea) or the disinterest in enrolling into an intervention, which involves long follow‐up and needs time commitment, etc. (37) Third, the characteristics of those who completed postpartum visits differed from those noncompleters. Those who remained in our study had higher socioeconomic status.…”

Effects of a behavioral intervention on physical activity, diet, and health-related quality of life in pregnant women with elevated weight: results of the HIPP randomized controlled trial

“…The CONSORT and TiDieR Checklists are included in Additional files 1 and 2. Participants were recruited primarily through 13 obstetrics and gynecology clinics in South Carolina [22]. The Institutional Review Boards from three participating healthcare centers and one university approved the study protocol.…”