Clinical trial NCT04731506: Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities
Official title: Family Connections: Cultural Adaptation and Feasibility Testing of a Technology-based Pediatric Weight Management Intervention for Rural Latino Communities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: University of Nebraska Lincoln
First posted: 2021-02-01
Enrollment: 158
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Body Mass Index z-score
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Child Self-reported Diet - Fruit and Vegetables
timeFrame: Baseline and 6 months
measure: Child Self-reported Diet - Sugar Sweetened Beverages
timeFrame: Baseline and 6 months
measure: Child Physical Activity
timeFrame: Baseline and 6 months
measure: Child Quality of Life
timeFrame: Baseline and 6 months
measure: Child Health Literacy
timeFrame: Baseline and 6 months
measure: Child Acculturation
timeFrame: Baseline and 6 months
measure: Home Environment
timeFrame: Baseline and 6 months
measure: Parent Body Mass Index
timeFrame: Baseline and 6 months
measure: Parent Self-reported Diet - Fruits and Vegetables
timeFrame: Baseline and 6 months
measure: Parent Self-reported Diet - Sugar Sweetened Beverages
timeFrame: Baseline and 6 months
measure: Parent Physical Activity
timeFrame: Baseline and 6 months
measure: Parent Quality of Life
timeFrame: Baseline and 6 months
measure: Parent Health Literacy
timeFrame: Baseline and 6 months
measure: Parent Acculturation
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Tzeyu Michaud, PhD
role: PRINCIPAL_INVESTIGATOR
References: