Feasibility of a culturally adapted technology-delivered, family-based childhood obesity intervention for Latino/Hispanic families in rural Nebraska: the Hispanic Family Connections study protocol

Introduction Addressing childhood obesity risk factors like home environment, parental roles, excess weight, physical activity and healthy eating among Latino/Hispanic (L/H) families living in rural communities is an important priority. However, evidence supporting these interventions among L/H families living in rural communities is missing. Our trial will use cultural adaptation and implementation science frameworks to evaluate the feasibility of delivering a culturally appropriate family-based childhood obesity (FBCO) programme via an automated telephone system (interactive voice response) to L/H families in rural Nebraska. Methods and analysis A mixed-methods feasibility trial for L/H families with overweight or obese children. Aim 1 will focus on collaboratively adapting and evaluating all intervention materials to fit the rural L/H community profile better, including translation of materials to Spanish, culturally relevant content and images, and use of health communication strategies to address different levels of health literacy. In aim 2, a 6-month feasibility trial with contextual evaluation will randomise 48 dyads (parent and child) to either Family Connections (FC; n=29) or a waitlist standard-care group (n=29) to determine overall study reach, preliminary effectiveness in reducing child body mass index (BMI) z-scores, potential for programme adoption, implementation and sustainability through local health departments (RE-AIM outcomes). We will also evaluate health department perceptions of the integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS) constructs (innovation, context, recipient characteristics) and FC participants' view of the intervention (ie, relative advantage, observability, trialability, complexity, compatibility). The study will answer three critical questions: (1) is a telephone-delivered FBCO programme in rural Nebraska culturally relevant, usable and acceptable by L/H families?; (2) is a telephone-delivered FBCO programme effective at reducing BMI z-scores in L/H children living in rural Nebraska? and (3) what real-world institutional and contextual factors influence the impact of the intervention and might affect its potential ability to sustainably engage a meaningful population of L/H families who stand to benefit? Ethics and dissemination This protocol was approved by the University of Nebraska Medical Center Institutional Review Board (IRB#:0745-20-EP). Dissemination of findings will occur through ClinicalTrials.gov, in scientific forums and to the local rural communities, pilot data to inform the design of a larger clinical trial. Trial registration number NCT04731506.