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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-04-22

Brief Summary

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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.

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Detailed Description

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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 6 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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Family Connection

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 6 months.

Group Type EXPERIMENTAL

Family Connections

Intervention Type BEHAVIORAL

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 6 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.

Waitlist Standard-Care

Parent participants will receive an activity workbook that promotes increased physical activity, healthy diets and decreased screen time and placement on 6-month delayed start (waitlist) in the FC program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 6 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No