Growing Healthy Together: protocol for a randomized clinical trial using parent mentors for early childhood obesity intervention in a Latino community

Byron A Foster, Kelsey Weinstein, Jackilen Shannon, Byron A Foster, Kelsey Weinstein, Jackilen Shannon

Abstract

Background: Latino children in the US experience high rates of obesity, increasing their risk of subsequent diabetes. There are few clinical trials among low-income, Latino families to test interventions that account for and address their unique situation.

Methods/design: This trial, conducted in a Head Start (early childhood education) setting, randomly assigns children 2-5 years of age who have obesity by CDC (Centers for Disease Control and Prevention) guidelines (at least 95th percentile body mass index) and their parents to one of three conditions: (1) control, (2) parent mentor with an experimental curriculum, or (3) parent mentor with a standard curriculum (active control). We designed the experimental arm (2) using data from positive deviants: low-income, Latino families who had been successful in moving their child toward a healthy weight. Parent mentors are recruited and trained from the Head Start centers. Parent mentors then facilitate the teaching and coaching of parent-child dyads with weekly interactions over the course of a 6-month period. The primary outcome is change in adjusted body mass index z-score at the end of intervention and at 6 months post-intervention. Secondary outcomes include generalized self-efficacy, dietary intake, the home food environment, and reported physical activity.

Discussion: This clinical trial contributes to the field by evaluating parent mentoring interventions that are potentially scalable for a population at high risk for continued obesity and subsequent morbidity and mortality.

Trial registration: This trial was registered on October 31, 2017 (ClinicalTrials.gov identifier: NCT03330743 ).

Keywords: Behavioral intervention mapping; Latino; Low-income population; Mentors; Obesity; Positive deviance; Preschool children; Randomized controlled trial.

Conflict of interest statement

Ethics approval and consent to participate

This study was reviewed and approved by the Oregon Health and Science University Institutional Review Board. Written informed consent will be obtained from all study participants in the preferred language of the participant (Spanish or English).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

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

Figures

Fig. 1
Fig. 1
Flowchart of steps in intervention mapping adapted for this trial. Progress is shown from right to left with positive deviance inquiry informing the behaviors identified in step 2.
Fig. 2
Fig. 2
Randomization and flow of participants through trial over time
Fig. 3
Fig. 3
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) figure: Primary and secondary outcomes, covariates, and assessment time points for parent–child dyads in the trial

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