Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities
- Conditions
- Childhood Obesity
- Interventions
- Behavioral: Family Connections
- Registration Number
- NCT04731506
- Lead Sponsor
- University of Nebraska
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 158
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Family Connection Family Connections 2 in-person sessions spaced one week apart \& 10 IVR calls/6 months; delivers intervention to parents only
- Primary Outcome Measures
Name Time Method Child Body Mass Index z-score Baseline and 6 months Child participant's Body Mass Index (BMI) z-score, a standardized way to measure a child's weight in relation to their age and sex, 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 and z-scores calculated using 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.
- Secondary Outcome Measures
Name Time Method Child Self-reported Diet - Fruit and Vegetables Baseline and 6 months 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.
Child Self-reported Diet - Sugar Sweetened Beverages Baseline and 6 months 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.
Child Physical Activity Baseline and 6 months 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.
Child Quality of Life Baseline and 6 months 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.
Child Health Literacy Baseline and 6 months 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.
Child Acculturation Baseline and 6 months 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.
Home Environment Baseline and 6 months 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.
Parent Body Mass Index Baseline and 6 months 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.
Parent Self-reported Diet - Fruits and Vegetables Baseline and 6 months 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.
Parent Self-reported Diet - Sugar Sweetened Beverages Baseline and 6 months 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.
Parent Physical Activity Baseline and 6 months 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.
Parent Quality of Life Baseline and 6 months 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.
Parent Health Literacy Baseline and 6 months 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.
Parent Acculturation Baseline and 6 months 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.
Trial Locations
- Locations (1)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States