An individually tailored family-centered intervention for pediatric obesity in primary care: study protocol of a randomized type II hybrid effectiveness-implementation trial (Raising Healthy Children study)

Justin D Smith, Cady Berkel, Neil Jordan, David C Atkins, Shrikanth S Narayanan, Carlos Gallo, Kevin J Grimm, Thomas J Dishion, Anne M Mauricio, Jenna Rudo-Stern, Mariah K Meachum, Emily Winslow, Meg M Bruening, Justin D Smith, Cady Berkel, Neil Jordan, David C Atkins, Shrikanth S Narayanan, Carlos Gallo, Kevin J Grimm, Thomas J Dishion, Anne M Mauricio, Jenna Rudo-Stern, Mariah K Meachum, Emily Winslow, Meg M Bruening

Abstract

Background: Pediatric obesity is a multi-faceted public health concern that can lead to cardiovascular diseases, cancers, and early mortality. Small changes in diet, physical activity, or BMI can significantly reduce the possibility of developing cardiometabolic risk factors. Family-based behavioral interventions are an underutilized, evidence-based approach that have been found to significantly prevent excess weight gain and obesity in children and adolescents. Poor program availability, low participation rates, and non-adherence are noted barriers to positive outcomes. Effective interventions for pediatric obesity in primary care are hampered by low family functioning, motivation, and adherence to recommendations.

Methods: This (type II) hybrid effectiveness-implementation randomized trial tests the Family Check-Up 4 Health (FCU4Health) program, which was designed to target health behavior change in children by improving family management practices and parenting skills, with the goal of preventing obesity and excess weight gain. The FCU4Health is assessment driven to tailor services and increase parent motivation. A sample of 350 families with children aged 6 to 12 years who are identified as overweight or obese (BMI ≥ 85th percentile for age and gender) will be enrolled at three primary care clinics [two Federally Qualified Healthcare Centers (FQHCs) and a children's hospital]. All clinics serve predominantly Medicaid patients and a large ethnic minority population, including Latinos, African Americans, and American Indians who face disparities in obesity, cardiometabolic risk, and access to care. The FCU4Health will be coordinated with usual care, using two different delivery strategies: an embedded approach for the two FQHCs and a referral model for the hospital-based clinic. To assess program effectiveness (BMI, body composition, child health behaviors, parenting, and utilization of support services) and implementation outcomes (such outcomes as acceptability, adoption, feasibility, appropriateness, fidelity, and cost), we use a multi-method and multi-informant assessment strategy including electronic health record data, behavioral observation, questionnaires, interviews, and cost capture methods.

Discussion: This study has the potential to prevent excess weight gain, obesity, and health disparities in children by establishing the effectiveness of the FCU4Health and collecting information critical for healthcare decision makers to support sustainable implementation of family-based programs in primary care.

Trial registration: NCT03013309 ClinicalTrials.gov.

Keywords: Coordinated care; Family Check-Up 4 Health; Hybrid effectiveness–implementation trial; Integrated care; Pediatric obesity; Primary care.

Conflict of interest statement

Ethics approval and consent to participate

The trial is designed in accordance with the basic ethical principles of autonomy, beneficence, justice, and non-maleficence and will be conducted in accordance with the rules of Good Clinical Practice outlined in the most recent Declaration of Helsinki. Written informed consent of patients will be required. Data confidentiality and anonymity will be ensured, according to the provisions of US law, both during the implementation phase of the study and in any resulting presentations or publications.

The study has been favorably evaluated by the Institutional Review Board of Arizona State University on July 14, 2016 (Protocol 00004530), and by the Institutional Review Board of the Phoenix Children’s Hospital on May 30, 2017 (Protocol 17-001). All other institutions participating in this research provided signed reliance agreements ceding to the Institutional Review Board of Arizona State University. A model of the informed consent completed by the participants of this trial is provided as an Additional file 1.

Any important protocol modification will be communicated to the Institutional Review Board of Arizona State University and updated in Clinicaltrials.gov.

Consent for publication

Not applicable.

Competing interests

JDS and CB are the co-developers of the Family Check-Up 4 Health program. TJD is the developer of the original Family Check-Up program. DCA and SSN are co-founders with equity stakes in a technology company, Lyssn.io, focused on tools to support training, supervision, and quality assurance of psychotherapy and counseling.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Steps and elements of the Family Check-Up for Health (FCU4Health) program in the Raising Healthy Children study
Fig. 2
Fig. 2
CONSORT flow diagram

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