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Behavioral Intervention
Home-Based Nutrition Program for Healthy Eating
N/A
Recruiting
Led By Alison Tovar, PhD MPH
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old
Speak English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-24-hour recalls at baseline and 2-24-hour recalls at 6-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a home-based nutrition program can help improve the diet quality of young children in low-income Latinx/Hispanic families. Participants will work with a support coach, have monthly
Who is the study for?
This trial is for Latinx/Hispanic primary caregivers, at least 18 years old, who have a child aged 2-5. They must live with the child most of the time, share at least three evening meals per week with them, and be willing to record one meal. Participants need a smartphone but shouldn't have been in the R34 study.
What is being tested?
The trial tests if a home-based nutrition program can improve children's diets. It involves monthly home visits and calls from a support coach over three months, plus educational materials and texts for six months. The effectiveness will be compared to a control group receiving different materials.
What are the potential side effects?
There are no direct medical side effects expected from participating in this intervention as it focuses on education and behavioral changes related to diet and feeding practices within families.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can communicate in English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-24-hour recalls at baseline and 2-24-hour recalls at 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-24-hour recalls at baseline and 2-24-hour recalls at 6-month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Child Diet Quality
Child's Dermal Carotenoids
Secondary study objectives
Availability of Healthy Foods in the Home
Food Parenting Practices
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-Based Video and Motivational Interviewing InterventionExperimental Treatment1 Intervention
The intervention will be delivered in English or Spanish by a trained CHW and consists of three home-based visits with tailored print materials, text-messages delivered 2x/week, followed by monthly tailored print materials and phone calls during the last three months of the intervention. For in-home visits, the CHW will deliver a Motivational Interviewing session based on scripts developed in the R34. For phone calls, parents will receive a 30-minute Motivational Interviewing phone call to check in on goals and barriers and reinforce earlier concepts. For text messages, parents will be sent two times/week messages related to objectives targeted during that month's visit, such as parents setting good examples and giving children autonomy in eating. For print materials, parents will receive printed materials, highlighting nutrition and parental feeding guidance.
Group II: Read Educate and Develop Youth (READY) ComparisonActive Control1 Intervention
As done in the R34, the comparison group will receive an attention contact control intervention about school readiness promotion adapted from R.E.A.D.Y. (Read Educate and Develop Youth) designed by the Michigan Department of Education (Refs). Families in the comparison arm will receive the same intervention components as the intervention arm, but these will be focused on child reading rather than nutrition. Parents will send a video of themselves reading with a child, receive 3 home visits and 48 text-messages as well as newsletters for each visit. Instead of receiving cooking materials during the second home visit, they will receive books to read with their children.
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Who is running the clinical trial?
Brown UniversityLead Sponsor
466 Previous Clinical Trials
698,808 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,067 Previous Clinical Trials
2,747,187 Total Patients Enrolled
Alison Tovar, PhD MPHPrincipal InvestigatorBrown University