Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099288
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-10-03
Brief Title:
Strong Families Start at HomeFamilias Fuertes Comienzan en Casa
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Strong Families Start at HomeFamilias Fuertes Comienzan en Casa A Novel Video and Motivational Interviewing Intervention to Improve Diet Quality of Low-income Ethnically Diverse Children
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 LatinxHispanic families The main questions it aims to answer are
Does this enhanced intervention change childrens 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
Does this enhanced intervention change childrens 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
Detailed Description:
Investigators will build on the recently completed R34 R34HL140229 that developed and pilot-tested the feasibility acceptability and preliminary efficacy of a novel home-based intervention to improve the diet quality and home food environment of low-income ethnically diverse preschool children 87 Latinx Despite the study occurring during COVID-19 the intervention delivery was feasible and acceptable to participants and achieved encouraging improvements in childrens diet quality and positive food parenting practices For the proposed research the investigators will build upon lessons learned in the pilot to evaluate the efficacy of the novel Strong Families intervention to improve food parenting practices home food environment parent and childrens diet quality in a fully powered randomized controlled trial RCT with 257 families of a 2-5-year-old child The intervention will include
Home visits by a community health worker CHW trained in brief motivational interviewing screening for social-determinants of health and connecting families to federalstatelocal resources in-home cooking demonstrations to prepare a meal involving their child feedback about a family meal-time video
Text-messages
Tailored materialsmessages
CHW phone calls
These strategies are expected to connect families to community systems increase parental knowledge self-efficacy and motivation for serving easy inexpensive healthy foods leading to increased child exposure to more healthy and varied foods improvements in parental feeding practices and ultimately improvements in child diet quality The RCT will include baseline 6 12-month measurements to test the following aims
Aim 1 Improve the dietary intakes of 2-5-year-old children
Aim 2 Improve food parenting practices
Aim 3 Improve the availability of healthy foods in the home
Home visits by a community health worker CHW trained in brief motivational interviewing screening for social-determinants of health and connecting families to federalstatelocal resources in-home cooking demonstrations to prepare a meal involving their child feedback about a family meal-time video
Text-messages
Tailored materialsmessages
CHW phone calls
These strategies are expected to connect families to community systems increase parental knowledge self-efficacy and motivation for serving easy inexpensive healthy foods leading to increased child exposure to more healthy and varied foods improvements in parental feeding practices and ultimately improvements in child diet quality The RCT will include baseline 6 12-month measurements to test the following aims
Aim 1 Improve the dietary intakes of 2-5-year-old children
Aim 2 Improve food parenting practices
Aim 3 Improve the availability of healthy foods in the home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD108832 | NIH | None | httpsreporternihgovquickSearchR01HD108832 |