Promotion of Family Routines and Positive Parent-Child Interactions for Obesity Prevention: Protocol for the 3 Pillars Study Randomized Controlled Trial

BACKGROUND: Childhood obesity is a challenging public health issue, with 30% of children aged 2 to 4 years classified as being overweight or obese in New Zealand. This is concerning, given that up to 90% of obese 3-year-old children are overweight or obese by the time they reach adolescence. Interventions that target this age range often fail to demonstrate long-term effectiveness and primarily focus on traditional weight-related behaviors, including diet and physical activity. However, research suggests that targeting nontraditional weight-related behaviors, such as sleep, screen time, and family meals, may be a more effective approach in this age group, given the immense challenges in changing traditional weight-related behaviors in the long term. OBJECTIVE: The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2 to 4 years to promote positive parent-child interactions during 3 family routines, specifically adequate sleep, regular family meals, and restricted screen time. METHODS: Screen time at the end of the 6-week program is the primary endpoint. The effects of the program on screen time, frequency of family meals, parent feeding practices, diet quality, and sleep duration will be piloted using a randomized controlled trial, with outcomes compared between the active intervention group and a wait-list control group at 6 weeks (at the end of the program) and 12 weeks (at final follow-up). We aim to recruit 50 participants (25 per arm). Eligibility criteria include parents of children aged 2 to 4 years who are currently exceeding screen use recommendations (ie, greater than 1 hour of screen time per day). The 3PS program involves a half-day workshop, run by a community worker trained to deliver the program content, and 6-week access to a study website that contains in-depth information about the program. All participants will also receive a study pack, which includes resources to encourage engagement in the 3 family routines promoted by the program. Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4 and have been specified a priori in a statistical analysis plan prepared by the study statistician. RESULTS: Trial recruitment opened in July 2018. Final follow-up was completed in December 2018, with trial findings expected to be available in early 2019. CONCLUSIONS: Findings from this pilot study will provide relevant data to inform the design of a larger effectiveness study of the 3PS program. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register ACTRN12618000823279; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=375004 (Archived by WebCite at http://www.webcitation.org/773CALeTK) INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12792