Childhood ObesityNCT04731506
Family Connections: Cultural Adaptation and Feasibility Testing for Rural Latino Communities
A study testing Family Connections in people with Childhood Obesity, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Family Connections
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Family Connections: Cultural Adaptation and Feasibility Testing of a Technology-based Pediatric Weight Management Intervention for Rural Latino Communities
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.
Read the 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 12 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
- Childhood Obesity
- Being tested
- Family Connections
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family ConnectionsBehavioural
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 12 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Experimental | 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 12 months.
Participants in the "standard care" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents participate in intervention activities (workbook, classes, calls). Receives: Behavioral: Family Connections |
| Waitlist | No intervention | Participants randomized into the control group will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. They will be waitlisted (placed on a 6-month delayed start) to receive the full Family Connections program. Participants in the "waitlist" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents later participate in intervention activities (workbook, classes, calls). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child- Change in BMI Z-score at 12 Months From Baseline
We used the mixed-effect regression model for the BMI z-score, weight, and BMI, regardless adults or kids. Weight was measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. For a child's BMI z-score, we use the formula Z=((BMI/M)^{L}-1)/(L\times S), where M, L, and S are parameters specific to the child's sex and age. For specific age and sex combinations, the parameters M, L, and S are obtained from reference data tables, provided by the CDC (https://www.cdc.gov/growthcharts/extended-bmi-data-files.htm). A Z-score indicates how many standard deviations a data point is from the mean.
For children and adolescents, specific z-score ranges are used to define weight status: (Negative Z-score, below mean) underweight (<-2), healthy weight (-2 to +1), (Positive Z-score, above mean) overweight (+1 to +2), and obese (>+2).
Z-scores \& Health: ≥0 greater risk for developing cardiovascular disease. <-2 osteoporosis and bone fractures risk.
Measured: 12 months
Adult- Change in BMI at 12 Months From Baseline
Adult participant's Body Mass Index (BMI), a standardized way to measure an adult's weight in relation to their height, will be determined at the initial in-person visit, then again at 12 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 using the 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Jun 2021
- Primary completion28 Feb 2024
- Study completion22 Apr 2025
Why it stopped: Principal Investigator returned to home country for cancer treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), University of Nebraska Lincoln
- Responsible party
- Sponsor
- Investigators
- Tzeyu Michaud, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731506
- Sponsor's protocol ID
- 0745-20-EP
- Other IDs
- P20GM104320
- Status last verified
- May 2025
- First submitted
- 25 Jan 2021
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary results will be shared with all identifiers removed at the completion of the study after all analyses have been finalized.
Publications
Brito FA, Alves TF, Santos N, Michaud TL, Eisenhauer C, De Leon EB, Squarcini CFR, Kachman S, Almeida F, Estabrooks P. Feasibility of a culturally adapted technology-delivered, family-based childhood obesity intervention for Latino/Hispanic families in rural Nebraska: the Hispanic Family Connections study protocol. BMJ Open. 2024 Oct 18;14(10):e089186. doi: 10.1136/bmjopen-2024-089186.
PubMed 39424377
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Connections: Cultural Adaptation and Feasibility Testing of a Technology-based Pediatric Weight Management Intervention for Rural Latino Communities
- ClinicalTrials.gov ID
- NCT04731506
- Acronym / sponsor ID
- 0745-20-EP
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator returned to home country for cancer treatment.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), University of Nebraska Lincoln
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 12 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Experimental | Behavioral: Family ConnectionsParent 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 12 months. Participants in the "standard care" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents participate in intervention activities (workbook, classes, calls). |
| Waitlist | No intervention | –Participants randomized into the control group will receive an activity workbook that promotes increased physical activity, healthy diets, and decreased screen time. They will be waitlisted (placed on a 6-month delayed start) to receive the full Family Connections program. Participants in the "waitlist" arm include parent-child dyads. Data are collected from both parents and their children; however, only parents later participate in intervention activities (workbook, classes, calls). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family ConnectionsParent 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 12 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. | Behavioural | Standard Care |
Primary outcome
Child- Change in BMI Z-score at 12 Months From Baseline
Time frame: 12 months
We used the mixed-effect regression model for the BMI z-score, weight, and BMI, regardless adults or kids. Weight was measured with a calibrated Heavy-Duty digital floor scale 880KL (www.homscales.com) in stocking feet. For a child's BMI z-score, we use the formula Z=((BMI/M)^{L}-1)/(L\times S), where M, L, and S are parameters specific to the child's sex and age. For specific age and sex combinations, the parameters M, L, and S are obtained from reference data tables, provided by the CDC (https://www.cdc.gov/growthcharts/extended-bmi-data-files.htm). A Z-score indicates how many standard deviations a data point is from the mean. For children and adolescents, specific z-score ranges are used to define weight status: (Negative Z-score, below mean) underweight (<-2), healthy weight (-2 to +1), (Positive Z-score, above mean) overweight (+1 to +2), and obese (>+2). Z-scores \& Health: ≥0 greater risk for developing cardiovascular disease. <-2 osteoporosis and bone fractures risk.
Adult- Change in BMI at 12 Months From Baseline
Time frame: 12 months
Adult participant's Body Mass Index (BMI), a standardized way to measure an adult's weight in relation to their height, will be determined at the initial in-person visit, then again at 12 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 using the 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39424377Brito FA, Alves TF, Santos N, Michaud TL, Eisenhauer C, De Leon EB, Squarcini CFR, Kachman S, Almeida F, Estabrooks P. Feasibility of a culturally adapted technology-delivered, family-based childhood obesity intervention for Latino/Hispanic families in rural Nebraska: the Hispanic Family Connections study protocol. BMJ Open. 2024 Oct 18;14(10):e089186. doi: 10.1136/bmjopen-2024-089186.
- Individual participant dataSharing planned: Yes. Summary results will be shared with all identifiers removed at the completion of the study after all analyses have been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzeyu Michaud, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Connections in people with Childhood Obesity, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child- Change in BMI Z-score at 12 Months From Baseline (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.