Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities
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.
Conditions:
🦠 Childhood Obesity
🗓️ Study Start (Actual)
1 June 2021
🗓️ Primary Completion (Estimated)
December 2024
✅ Study Completion (Estimated)
December 2025
👥 Enrollment (Estimated)
126
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Omaha, Nebraska, United States
Description
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
Ages Eligible for Study:
6 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
25 January 2021
- First Submitted that Met QC Criteria
28 January 2021
- First Posted
1 February 2021
Study Record Updates
- Last Update Submitted that Met QC Criteria
29 September 2023
- Last Update Posted
3 October 2023
- Last Verified
September 2023