Protocol for the Southeast Asian Healthy Habits, Healthy Kids (SEAHK) study, a culturally tailored family-based pilot randomized controlled trial to improve dietary quality.

Abstract

Background: Southeast Asian (SEA) children are burdened by high rates of diet-related chronic conditions and diseases. These burdens partly result from socioeconomic disadvantages and refugee migration trajectories. Yet, to our knowledge, no dietary interventions exist for this population. This protocol paper describes the rationale, study design, intervention and study evaluation for the SEA Healthy Habits, Healthy Kids Study.

Methods: The study enrollment goal was 75 parent-child dyads recruited in Providence, Rhode Island, in the United States. A SEA parent/guardian and one of their 6-to-11-year-old children were randomized to (1) a monthly financial incentive only group; (2) an enhanced financial incentive group that receives additional interventions including family-based group nutrition education, three motivational interviewing (MI) phone calls, and weekly text messages on healthy eating norms and other nutrition topics; or (3) a structurally equivalent attention-matched control group. The primary study goals were to assess feasibility and acceptability, conduct process evaluation to determine implementation fidelity and intervention dose, and determine preliminary efficacy. Feasibility was assessed based on attendance (primary) and secondary measures, recruitment, enrollment, intervention dose, and retention at 6 months. Acceptability was measured using satisfaction questionnaires on study favorability. Preliminary efficacy (i.e., comparing changes in children's diet quality (Healthy Eating Index and dermal carotenoids)) will be determined via longitudinal mixed effects models. Regression models will investigate the relationship between dose, implementation measures and study outcomes.

Results: This intervention received Institutional Review Board approval on February 16, 2023. We conducted intervention development from July 2022 to August 2022 with 62 SEA parents and children. For the intervention, we began participant recruitment in April 2023, which concluded January 2025.

Discussion: This study will demonstrate whether a culturally tailored healthy eating intervention for SEA families is feasible and acceptable and whether it leads to changes on key efficacy indicators. The intervention is informed by theories and frameworks relevant for the population and utilizes a family-centered approach. If this innovative pilot intervention achieves the study objectives, then we will refine it and pursue a larger randomized control trial.

Trial registration: This study is registered at ClinicalTrials.gov under registration number NCT05817838. The trial was registered on April 17, 2023. The trial registry record is available at https://clinicaltrials.gov/study/NCT05817838 .