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Baseline Targeted Moderation in a Trial of the Family Check-Up 4 Health: Potential Explanations for Finding Few Practical Effects

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Abstract

Not all participants will benefit equally from even well-established, evidence-based prevention programs. For this reason, the field of prevention science is beginning to embrace individual tailoring of interventions. The Family Check-Up was among the first prevention programs to tailor at the family level as opposed to the more prevalent focus on adapting programs for different cultures, genders, and other immutable participant characteristics. Despite tailoring, families with lower levels of stress and parental mental health issues, children with lower baseline conduct problems, and families living in an extremely deprived neighborhood benefitted less from the Family Check-Up. This study examined baseline targeted moderation (BTM) within a trial of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the Family Check-Up for primary care delivery and explicit targeting of obesogenic behaviors. Ethnically diverse, low-income families (N = 240) with children ages 5.5 to 12 years identified in pediatric primary care with elevated body mass index (BMI) were enrolled and randomized to FCU4Health or usual care. Few BTM effects were found using single-variable-as-moderator and latent-class-as-moderator analytic approaches across the primary (child BMI, body composition) and secondary outcomes (family health routines; child eating behaviors, food choices, emotional problems, problem behaviors, quality of life; caregiver BMI and body composition), as well as hypothesized mediators (child self-regulation, parenting skills). The high-risk nature of the sample and the FCU4Health being individually tailored might have mitigated finding BTM effects. This trial was prospectively registered (NCT03013309 ClinicalTrials.gov).

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Funding

This study was supported by the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control & Prevention (U18 DP006255; Berkel & Smith).

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Correspondence to Justin D. Smith.

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Ethics Approval

This trial was designed in accordance with the basic ethical principles of autonomy, beneficence, justice, and non-maleficence and conducted in accordance with the rules of Good Clinical Practice outlined in the most recent Declaration of Helsinki. The project was approved by the Institutional Review Boards of Arizona State University (Protocol 00004530) and Phoenix Children’s Hospital (Protocol 17–001). All other institutions participating in this research provided signed reliance agreements ceding to the IRB of Arizona State University.

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Consent and assent were obtained from all participants included in the study.

Conflict of Interest

Berkel and Smith co-developed the Family Check-Up 4 Health program with Thomas Dishion, developer of the original Family Check-Up.

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Smith, J.D., Carroll, A.J., Fu, E. et al. Baseline Targeted Moderation in a Trial of the Family Check-Up 4 Health: Potential Explanations for Finding Few Practical Effects. Prev Sci 24, 226–236 (2023). https://doi.org/10.1007/s11121-021-01266-z

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