Method: A type II hybrid Implementation-effectiveness trial was conducted in three clinics (one large hospital-based outpatient clinic and two small federally qualified health centers). All three served primarily low-income, Mexican-origin families. Eligibility criteria were child BMI (≥85th percentile) and age (6-12 years). Families were recruited via two mechanisms: during a visit with their primary care provider or over the phone by a recruiter for the study after identification via electronic health record (EHR) query. Assessments were conducted by study interviewers or clinic staff. After the first assessment, families were randomized to services as usual or to FCU4Health, which was delivered as an integrated service in the clinic or through a referral to an external provider.
Results: A chi-square test showed that recruitment method (clinic visit or EHR calls) did not significantly affect study engagement. Among the 363 families who were screened eligible, 338 (93%) enrolled in the study. Enrolled family characteristics: 49% female, 86% racial/ethnic minority, 33% extreme obesity (BMI ≥ 120% percentile), and 30% asthmatic. To date, pretest interviews have been conducted with 235 families, with 100 randomly assigned to treatment as usual and 135 to FCU4Health. Of those families randomized to the intervention, 70% have initiated services (i.e., participated in the first program session).
Conclusions: It is difficult to make comparisons about engagement rates across studies because of different populations and recruitment strategies. However, as a point of reference, initiation rates in previous trials of the original Family Check-Up program ranged from 23-76%. Consequently, results of the current study indicate that primary care has strong potential for delivering evidence-based prevention programs to the target population. In the next phase of analysis, predictors of study enrollment and program initiation will be examined, including demographics (race/ethnicity, language, insurance status, food insecurity, gender, and age), health indicators (BMI, asthma, diabetes, quality of life), and readiness for change.