Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities

Family Connections: Cultural Adaptation and Feasibility Testing of a Technology-based Pediatric Weight Management Intervention for Rural Latino Communities

There are marked ethnic and rural-urban disparities in the prevalence of childhood obesity (CO). Among Latino/Hispanic children, CO is almost 60% higher than that of non- Latino/Hispanic Whites, and among children in rural areas it is estimated to be 25% to almost 50% higher that of urban areas. By 2050 Latinos are expected to represent 51.2% of rural Nebraska's population, so addressing childhood obesity risk factors among Latinos/Hispanic families living in rural communities and Identifying effective interventions is an important priority. The first aim will be to collaboratively adapt all intervention materials to better fit the rural Latino/Hispanic community, including translation of materials to Spanish, inclusion of culturally relevant content and images, and use of health communication strategies to address different levels of health literacy. The second aim randomly assign enrolled participant dyads (parent and child) to either Family Connections (FC) or a waitlist standard-care (SC) group to determine preliminary effectiveness in reducing child body mass index (BMI) z-score (a standardized way to measure a child's weight in relation to their age and sex). This study will address three important questions as they apply to Latino/Hispanic in rural Nebraska: is a telephone delivered family-based childhood obesity (FBCO) program in rural Nebraska culturally relevant, usable and acceptable, is a telephone delivered FBCO program effective at reducing child BMI z-scores and what real-world factors influence the impact of the intervention to sustainably engage a meaningful population of Latino/Hispanic families who stand to benefit.

Study Overview

• Status: Terminated
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Family Connections

Detailed Description

The childhood obesity (CO) rate of Latinos/Hispanics, the fastest growing rural population group, is 60% higher than their non-Hispanic neighbors. Family-based childhood obesity (FBCO) interventions targeting parents have shown promising results for reducing weight among children. However, these interventions are developed and evaluated with culturally homogeneous samples of participants in large urban areas and have been poorly accessed by Latino/Hispanic families living in rural communities. There are a number of barriers to accessing these interventions in rural Nebraska communities including increasing ethnic health disparities, limited available resources, shortage of available health professionals, and the existence of demographically and geographically segregated communities. Community members have reported that family and work responsibilities, lack of public transportation, and language and cultural relevance have kept them from engaging in these programs. Interactive technologies may provide a possible solution to these challenges in that they offer an avenue for the delivery of FBCO interventions at times and places convenient to participants.

Investigators have found that a technology-assisted FBCO intervention can lead to significant weight loss among children and that over 82% of Latinos/Hispanics in studies have mobile devices regularly used to access information and make phone calls. Thus, telephone systems that provide automated (i.e., interactive voice response (IVR) system) FBCO messages may be practical methods for delivering culturally appropriate health information and engaging Latino/Hispanic families in rural communities. Family Connections (FC) is a scalable intervention that uses IVR to deliver FBCO content; however, it was not specifically developed for Latino/Hispanic rural families.

This study will build on investigators' experience in the use of interactive technologies to deliver FBCO content and promote healthy behaviors and weight control, culturally adapting interventions and working collaboratively with stakeholders in a variety of settings. The first aim is to culturally adapt a relevant and acceptable technology-delivered FBCO intervention. A mixed-methods approach will be used that includes a community workgroup facilitated by our rural partner organizations in Nebraska and a using structured community input adaptation process. The next study aim will follow-up to evaluate the feasibility and preliminary effectiveness of this intervention with Latino/Hispanic rural families in Nebraska. Participants will be randomly assigned to one of two groups: a technology-delivered Family Connections (FC) group or a waitlist standard-care (SC) group. Both groups will receive a workbook. The FC group will additionally receive two in-person group sessions followed by 10 IVR calls over a period of 12 months. The two groups will be compared to determine program effectiveness in reducing child BMI z-scores, diet, physical activity, health literacy, and quality of life.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Intervention Adult Participants

• Age ≥ 19 years
• Self-identified as Latino/Hispanic living in target counties
• Parent of a child aged 8-12 years with a BMI z-score ≥85th
• Willing and able to give informed consent

Children Participants

• Age 6-12 years
• Body Mass Index (BMI) z-score ≥85th percentile
• Self-Identified as Latino/Hispanic living in target counties
• Assent to participate in the study

Exclusion Criteria:

• Contraindication to physical activity or weight loss
• Planning to move in the next 12 months
• Currently participating in weight loss program
• Pregnancy or planning to get pregnant in the next 12 months
• Not willing to be randomized
• Not willing to consent or assent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Care; Parent participants will receive an activity workbook that promotes increased physical activity, healthy diets and decreased screen time, two in-person support sessions spaced and 10 Interactive Voice Response (IVR) automated telephone system calls providing health education messages over 12 months. Participants in the "standard care" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents participate in intervention activities (workbook, classes, calls).	Behavioral: Family Connections; Parent participants will receive an activity workbook that promotes increased physical activity and consumption of fruits and vegetables and decreased screen time and intake of sugary drink consumption, two in-person support sessions to help parents to develop an action plan spaced one week apart & Interactive Voice Response (IVR) automated telephone system calls of 5 to 10 minutes that provide health education messages over 12 months (4 weekly, 4 biweekly (4), and 2 monthly). During each IVR call parents provide information on current physical activities, and food consumption that is used to provide feedback on success in subsequent IVR calls.
No Intervention: Waitlist; Participants randomized into the control group will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. They will be waitlisted (placed on a 6-month delayed start) to receive the full Family Connections program. Participants in the "waitlist" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents later participate in intervention activities (workbook, classes, calls).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child- Change in BMI Z-score at 12 Months From Baseline	We used the mixed-effect regression model for the BMI z-score, weight, and BMI, regardless adults or kids. Weight was measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. For a child's BMI z-score, we use the formula Z=((BMI/M)^{L}-1)/(L\times S), where M, L, and S are parameters specific to the child's sex and age. For specific age and sex combinations, the parameters M, L, and S are obtained from reference data tables, provided by the CDC (https://www.cdc.gov/growthcharts/extended-bmi-data-files.htm). A Z-score indicates how many standard deviations a data point is from the mean. For children and adolescents, specific z-score ranges are used to define weight status: (Negative Z-score, below mean) underweight (<-2), healthy weight (-2 to +1), (Positive Z-score, above mean) overweight (+1 to +2), and obese (>+2). Z-scores & Health: ≥0 greater risk for developing cardiovascular disease. <-2 osteoporosis and bone fractures risk.	12 months
Adult- Change in BMI at 12 Months From Baseline	Adult participant's Body Mass Index (BMI), a standardized way to measure an adult's weight in relation to their height, will be determined at the initial in-person visit, then again at 12 months. Height will be measured in stocking feet with a calibrated stadiometer with a fixed vertical backboard and adjustable headboard. Weight will be measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. BMI will be calculated in kg/m2 using the established Centers for Disease Control and Prevention protocol. Higher scores mean a worse outcome. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Self-reported Diet - Fruit and Vegetables	Child participant intake of fruit and vegetables will be assessed from the Fruit and Vegetable Module Behavioral Risk Factor Surveillance System (BRFSS) Fruits and Vegetables module. The Fruit and Vegetable Module asks six questions about fruit and vegetable consumption during the last 30 days. Responses are the number of times per day, week or month which are then totaled and the proportion of participants consuming recommended amounts determined. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Child Self-reported Diet - Sugar Sweetened Beverages	Child participant intake of sugar sweetened beverages will be assessed using the Beverage Intake Questionnaire (BEVQ-15). The instrument asks about consumption of categories of beverages and amounts which are calculated as average daily consumption in fluid ounces (fl oz). For total sugar-sweetened beverage (SSB), consumption is calculated by summing the fluid ounce intake of categories containing added sugars. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Child Physical Activity	Child participant's physical activity will be measured at the initial in-person visit, then again at 6 months using the Godin Leisure Time Exercise Questionnaire. This instrument categorizes exercise: mild/light (minimal effort, value 3), moderate (not exhausting, value 5) and strenuous (heart beats rapidly, value 9). The number of times per week for each level is multiplied by the value for the level and these scores are totaled. Scores less than 14 are termed insufficiently active/sedentary, 14 to 23 are termed moderately active and 24 or more are termed active. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Child Quality of Life	Child participant's quality of life will be assessed at the initial in-person visit, then again at 6 months using the Pediatric Quality of Life Inventory (PEDS- QL). This 23 item instrument assesses physical, emotional, social, and school functioning. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better health-related quality of life. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Child Health Literacy	Child participant's health literacy will be assessed at the initial in-person visit, then again at 6 months using the Newest Vital Sign (NVS) screening tool. One point is given for each correct answer up to a maximum of 6 points. Higher scores indicate better health literacy skills. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Child Acculturation	Child participant's acculturation, the assimilation into a non-native culture, will be assessed at the initial in-person visit, then again at 6 months using the Short Acculturation Scale for Hispanic Youth (SASH-Y). This instrument is a 12-item self-report scale used assesses acculturation through language use, media preferences, and social relations. Participant preferences are scored on a five-point Likert-type scale, with anchors like "only Spanish" (1) and "only English" (5) for language-related items, and "all Latinos/Hispanics" (1) and "all Americans" (5) for ethnic-preference items with higher total scores indicating greater levels of acculturation.	Baseline and 6 months
Home Environment	Parent participant's assessment of their home environment at the initial in-person visit, then again at 6 months will be evaluated using the Comprehensive Home Environment Survey (CHES). This instrument examines the home food, physical activity, and media environment. Items are scored from 1 (never) to 5 (always). Response scores will be converted to a continuous scale ranging from 0 to 1, including reversed coding when necessary. The total score is calculated using the sum of the scores of the subscales where a higher total score on the scales indicates a home environment more supportive of health behaviors. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Parent Body Mass Index	Parent participant's Body Mass Index (BMI) will be determined at the initial in-person visit, then again at 6 months. Height will be measured in stocking feet with a calibrated stadiometer with a fixed vertical backboard and adjustable headboard. Weight will be measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. BMI will be calculated in kg/m2. The higher score the mean a worse outcome. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Parent Self-reported Diet - Fruits and Vegetables	Parent participant intake of fruit and vegetables will be assessed from the Fruit and Vegetable Module Behavioral Risk Factor Surveillance System (BRFSS) Fruits and Vegetables module. The Fruit and Vegetable Module asks six questions about fruit and vegetable consumption during the last 30 days. Responses are the number of times per day, week or month which are then totaled and the proportion of participants consuming recommended amounts determined. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Parent Self-reported Diet - Sugar Sweetened Beverages	Parent participant intake of sugar sweetened beverages will be assessed using the Beverage Intake Questionnaire (BEVQ-15). The instrument asks about consumption of categories of beverages and amounts which are calculated as average daily consumption in fluid ounces (fl oz). For total sugar-sweetened beverage (SSB), consumption is calculated by summing the fluid ounce intake of categories containing added sugars. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Parent Physical Activity	Parent participant's physical activity will be measured at the initial in-person visit, then again at 6 months using the Godin Leisure Time Exercise Questionnaire. This instrument categorizes exercise: mild/light (minimal effort, value 3), moderate (not exhausting, value 5) and strenuous (heart beats rapidly, value 9). The number of times per week for each level is multiplied by the value for the level and these scores are totaled. Scores less than 14 are termed insufficiently active/sedentary, 14 to 23 are termed moderately active and 24 or more are termed active. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Parent Quality of Life	Parent participant's quality of life will be assessed at the initial in-person visit, then again at 6 months using the Behavioral Risk Factor Surveillance System (BRFSS). This system estimates the number of recent days when physical and mental health was good or better. The higher number of good or better days indicates greater physical and mental health. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Parent Health Literacy	Parent participant's health literacy will be assessed at the initial in-person visit, then again at 6 months using the Newest Vital Sign (NVS) screening tool. One point is given for each correct answer up to a maximum of 6 points. Higher scores indicate better health literacy skills. Comparisons of scores at the time points will be made between groups to evaluate program effectiveness.	Baseline and 6 months
Parent Acculturation	Parent participant's acculturation, the assimilation into a non-native culture, will be assessed at the initial in-person visit, then again at 6 months using the Bidimensional Acculturation Scale. This instrument is a 24 item measure of general language use, language proficiency, and language use in media. Each item is scored using a Likert scale (1 = almost never, 4 = almost always) with higher total scores indicating greater levels of acculturation.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: National Institute of General Medical Sciences (NIGMS); University of Nebraska Lincoln
• Investigators: Principal Investigator: Tzeyu Michaud, PhD, University of Nebraska

Publications and helpful links

General Publications

• Brito FA, Alves TF, Santos N, Michaud TL, Eisenhauer C, De Leon EB, Squarcini CFR, Kachman S, Almeida F, Estabrooks P. 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. BMJ Open. 2024 Oct 18;14(10):e089186. doi: 10.1136/bmjopen-2024-089186.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): April 22, 2025

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: 0745-20-EP; P20GM104320 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Summary results will be shared with all identifiers removed at the completion of the study after all analyses have been finalized.
• IPD Sharing Time Frame: Summary results (de-identified) will be shared at the completion of the study.
• IPD Sharing Access Criteria: Request submitted to the to the Principal Investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No