Strong Families Start at Home/Familias Fuertes Comienzan en Casa (NCT06099288) | Clinical Trial Compass
RecruitingNot Applicable
Strong Families Start at Home/Familias Fuertes Comienzan en Casa
United States257 participantsStarted 2024-01-01
Plain-language summary
The goal of this clinical trial is to test the ability of a home-based parental nutrition intervention to improve diet quality in preschool aged children within low-income, Latinx/Hispanic families. The main questions it aims to answer are:
* Does this enhanced intervention change children's diet quality?
* Does this enhanced intervention change parental feeding practices?
* Does this enhanced intervention change the availability of healthy foods in the home?
Participants will:
* Work with a support coach
* Have a home visit with a support coach once a month, for three months
* Have a phone call with a support coach once a month, for three months
* Receive written materials and text messages over the six months
Researchers will compare a control group receiving different written materials and messages to see if the enhanced intervention changes diet quality in children.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years old
* Self-identity as Latinx/Hispanic
* Speak English or Spanish
* Be the primary caregiver of a child between 2- 5 years of age
* Live with the child most of the time
* Eat a minimum of three evening meals per week with the child
* Not have participated in the R34 study
* Have a smart phone
* Be willing to have a meal video recorded in the home
Exclusion Criteria:
* A doctor or WIC provider has told them that their child was underweight in the past 6 months
* The child has a diagnosed feeding disorder or dietary restriction that impacts how they eat
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Child Diet Quality
Timeframe: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up