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

Childhood Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731506
• Other study ID #: 0745-20-EP
• Secondary ID: P20GM104320
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: Alves F Thais, PhD
• Phone: 402-290-9045
• Email: thais.alves[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Addressing childhood obesity risk factors like home environment, parental roles, excess weight, physical activity, and healthy eating among Latinos/Hispanic (L/H) families living in rural communities is an important priority. This study proposes to use cultural adaptation and implementation science frameworks to evaluate the feasibility of delivering a culturally appropriate family-based childhood obesity (FBCO) program via an automated telephone system (IVR) to L/H families living in rural Nebraska. We will conduct a mixed-methods feasibility trial for L/H families with overweight or obese children. In Aim 1, we will first collaboratively adapt all intervention materials to better fit the rural L/H community profile, 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. Then, we will evaluate the cultural relevance, suitability, and usability of the adapted intervention materials and mode of delivery. In Aim 2, we will randomly assign participant dyads (parent and child) to either Family Connections (n=29) or a waitlist standard-care group (n=29) and determine overall study reach, preliminary effectiveness in reducing child BMI z- scores, potential for program adoption, implementation, and sustainability through local health departments (RE-AIM outcomes). We will also evaluate health department perceptions of i-PARIHS constructs (innovation, context, recipient characteristics), and Family Connections participants' view of the intervention (i.e., relative advantage, observability, trialability, complexity, compatibility). In conclusion, the study will answer three important questions: (1) Is a telephone delivered FBCO program in rural Nebraska culturally relevant, usable and acceptable by L/H families? (2) Is a telephone delivered FBCO program 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? This project will generate locally and globally relevant evidence on a culturally appropriate technology-delivered FBCO intervention for L/H families in rural communities.

Description:

Latinos/Hispanics are the fastest growing population group in rural areas and their childhood obesity rate 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 patients and have been poorly accessed by L/H families living in rural communities. The majority of FBCO programs have been based in large urban areas and do not address geographically underserved audiences or settings and might not be optimal for patients who are culturally diverse. There are a number of barriers to accessing these interventions in rural communities. Health departments in rural Nebraska have reported increasing health disparities and limited available resources, shortage of available health professionals, and the existence of demographically and geographically segregated communities as barriers to offer these programs. Community members have reported that family and work responsibilities, lack of public transportation, 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. Our team has found that a technology-assisted FBCO intervention can lead to significant weight loss among children and that over 82% of L/Hs in our studies have mobile devices and use it regularly for telephone usage and access information. Given the growing usage of mobile technologies by all populations, including L/Hs, and the potential promise of technology-assisted interventions, it is surprising that to date there have been no reports of FBCO interventions using mobile technology targeting L/H families living in rural areas. 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 L/Hs 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 rural L/H families. The goal of this application is to culturally adapt and determine the feasibility of delivering FBCO content using IVR technology to L/H families in rural Nebraska. This study is significant by addressing risk factors with a high burden among L/H children, where knowledge regarding efficacious interventions and adaptations is substantial; yet have not demonstrated the ability to attract a large representative sample of L/H families and be sustained in rural communities. It builds on our team's extensive experience in (1) the use of interactive technologies to deliver FBCO content and promote healthy behaviors and weight control; (2) culturally adapting interventions; (3) working collaboratively with stakeholders in a variety of settings. Building on this experience and guided by implementation science models (RE-AIM and i-PARIHS) we will use a mixed-method collaborative process to culturally adapt and test FC. This proposal is innovative by using cultural adaptation and implementation science models to evaluate the feasibility of delivering FBCO content via an IVR system to L/H parents of obese children in rural Nebraska. This application allow us to address existing participation and setting barriers while capitalizing on the preferences of our target population. Our primary specific aims are:

Aim 1: To culturally adapt and determine the relevance, acceptability, and usability of a culturally adapted technology-delivered FBCO intervention for L/H families in rural Nebraska. Applying an iterative collaborative process, we will use a mixed-methods approach to culturally adapt FC to better fit the rural L/H community profile. A Community Workgroup facilitated by our rural partner organizations in Nebraska with a high population of L/H residents and theory-and data-driven approach using structured community input adaptation process will be conducted to develop and evaluate the relevance (ecological validity and equivalence), acceptability, and usability of all the adaptations made. We hypothesize that this process will lead to a program that is relevant, acceptable, and usable by L/H families in rural communities.

Aim 2: To evaluate the feasibility and preliminary effectiveness of a technology-delivered FBCO intervention for L/H families in rural Nebraska using RE-AIM and i-PARIHS. We will randomly assign participants to either FC (n=29) or a waitlist standard-care (SC) group (n=29) and determine overall study reach, preliminary effectiveness in reducing child BMI z-scores, potential for program adoption, implementation, and sustainability through local health departments (RE-AIM outcomes). SC participants will receive a workbook. FC participants will receive a workbook, 2 in person group sessions followed by 10 IVR calls over a period of 6 months. We hypothesize that a culturally adapted FC program will lead to a higher engagement (reach, retention and completion), significant higher proportion of L/H children reducing their BMIz scores at 6 months when compared to SC group, align (social validity) with health department perceptions of i-PARIHS constructs (Innovation, context, recipient characteristics), and that FC participants will view the intervention positively (i.e. relative advantage, observability, trialability, complexity, compatibility).

This project will generate locally and globally relevant evidence on culturally appropriate technology- delivered FBCO intervention for L/H families in rural communities. Given the rapidly growing population of L/Hs in the USA, it is also immediately relevant to the health of the US population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

Intervention Adult Participants

1. Age = 19 years

2. Self-identified L/Hs living in target counties

3. Parent of a child aged 8-12 years with a BMI z-score =85th

4. Willing and able to give informed consent

Children Participants

1. Age 6-12 years

2. BMI z-score =85th percentile

3. Self-Identified L/Hs living in target counties

4. Assent to participate in the study

Exclusion Criteria:

1. No telephone

2. Contraindication to physical activity or weight loss

3. Planning to move in the next 12 months

4. Currently participating in weight loss program

5. Pregnancy or planning to get pregnant in the next 12 months

6. Not willing to be randomized

7. Not willing to consent or assent to participate

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Family Connections
The program starts with 2 small group support sessions spaced one week apart that guides participants through developing an action plan; followed by 10 IVR calls (5-10 minutes) beginning with weekly (4), biweekly (4), and monthly (2) calls. 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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of General Medical Sciences (NIGMS), University of Nebraska Lincoln

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child BMI z-score	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 and z scores calculated using established Centers for Disease Control and Prevention protocol. This is an age and gender normed standardization of child weight status, the higher score the mean a worse outcome.	Change at 6- and 12-months post baseline
Secondary	Child self-reported diet	Increase in Fruit and vegetables servings and reduction of sugar sweetened beverage consumption, wich are related to health habits and better outcomes, measured by Behavioral Risk Factor Surveillance System (BRFSS) fruits and vegetables and Beverage Intake Questionnaire (BEVQ-15).	Change at 6- and 12-months post baseline
Secondary	Child physical activity	Increase in time of vigorous, moderate, mild exercise. Measured by Godin-Shephard questionnaire. Score and category (active/insufficient) with cut-point values for the classification scoring are based on the North American public health PA guidelines, that are defined as follows: individuals reporting moderate-to-strenuous LSI = 24 are classified as active whereas individuals reporting moderate-to-strenuous LSI = 23 are classified as insufficiently active (estimated energy expenditure < 14 Kcal/kg/week).	Change at 6- and 12-months post baseline
Secondary	Child quality of life	Physical Health and Psychosocial Health Score, Sum Score. Measured by Pediatric Quality of Life Inventory (PEDS- QL). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).	Change at 6- and 12-months post baseline
Secondary	Child health literacy	Health literacy and Numeracy, Sum score of and categorized (limited/adequate). Measured by New Signal Vital (NVS) screening tool. Score by giving 1 point for each correct answer (maximum 6 points) where higher scores indicate better health literacy skills.	Change at 6- and 12-months post baseline
Secondary	Child acculturation	External language use, familial language use, social relations scores, total score, rank (low/high). Measured by Short Acculturation Scale for Hispanic Youth (SASH-Y). Scores range from 4 to 20, with higher scores indicating greater levels of acculturation.	Change at 6- and 12-months post baseline
Secondary	Home environment	Food, Physical activity, and Media home environment scores and total score. Measured by Comprehensive Home Environment Survey. The CHES items responses were 5-point scales from 1 (never) to 5 (always). For analytic purposes, all response scores will be converted to a continuous scale ranging from 0 to 1, including reversed coding when necessary. 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.	Change at 6- and 12-months post baseline
Secondary	Parent BMI	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. Higher BMI means a worse outcome.	Change at 6- and 12-months post baseline
Secondary	Parent self-reported diet	Increase in Fruit and vegetables servings and reduction of sugar sweetened beverage consumption, wich are related to health habits and better outcomes, measured by Behavioral Risk Factor Surveillance System (BRFSS) fruits and vegetables and Beverage Intake Questionnaire (BEVQ-15).	Change at 6- and 12-months post baseline
Secondary	Parent physical activity	Increase in time of vigorous, moderate, or mild exercise and reduction of sedentary behaviors. Score and category (active/insufficient). Measured by Godin Leisure Time Exercise Questionnaire. Score and category (active/insufficient) with cut-point values for the classification scoring are based on the North American public health PA guidelines, that are defined as follows: individuals reporting moderate-to-strenuous LSI = 24 are classified as active whereas individuals reporting moderate-to-strenuous LSI = 23 are classified as insufficiently active (estimated energy expenditure < 14 Kcal/kg/week).	Change at 6- and 12-months post baseline
Secondary	Parent quality of life	Increase of general health status and number of Healthy Days. Measured by BRFSS Healthy Days that estimates the number of recent days when a person's physical and mental health was good (or better).	Change at 6- and 12-months post baseline
Secondary	Parent health literacy	Health literacy and Numeracy, Sum score of and categorized (limited/adequate). Measured by New Signal Vital-NVS.Score by giving 1 point for each correct answer (maximum 6 points) where higher scores indicate better health literacy skills.	Change at 6- and 12-months post baseline
Secondary	Parent acculturation	Language and media use, and social-ethnic relations scores, total score and rank (low/high). Measured by Bidimensional Acculturation Scale a 24 item measure of acculturation with higher scores indicating greater levels of acculturation.	Change at 6- and 12-months post baseline