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NCT03923491 · ClinicalTrials.gov registry record · NA

A Home-based Intervention to Improve the Diet Quality of Preschoolers

A NA study, sponsored by University of Rhode Island.

Completed
Registry status
NA
Development phase
63
Enrollment target

NCT03923491: Completed NA study, sponsored by University of Rhode Island.

NCT03923491 is a NA study that has completed, run by University of Rhode Island. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03923491, a NA study, has completed, sponsored by University of Rhode Island.

COMPLETED
Registry status
NA
Development phase
63 participants
Enrollment target

Study Summary

U.S. children eat too little fruits and vegetables and whole grains, and too many energy dense foods, dietary behaviors associated with increased morbidity from cardiovascular diseases. Parents play a key role in shaping their child's diet and best practices suggest that parents should involve children in food preparation, offer, model and encourage a variety of healthy foods. In addition, while parents help to shape food preferences, not all children respond in the same way and certain appetitive traits, such as satiety responsiveness (sensitivity to internal satiety signals), food responsiveness (sensitivity to external food cues), and enjoyment of food may help explain some of these differences. Prior interventions among preschool aged children to improve their diet have not used a holistic approach that fully targets the home food environment, by focusing on food quality, food preparation, and positive feeding practices while acknowledging a child's appetitive traits. This proposal will build upon pre-pilot work to develop and pilot-test the feasibility, acceptability and preliminary efficacy of a novel home-based intervention. The proposed 6-month intervention, will include 3 monthly home visits by a community health worker (CHW) trained in motivational interviewing, that include in-home cooking demos. In between visits, parents will receive tailored text-messages 2x/wk. and monthly mailed tailored materials. During the last 3 months CHW phone calls will replace the home visits. The intervention will be tailored for individual families based on the child's appetitive traits. The proposed research will lay the groundwork for a larger trial to support, motivate, and empower low-income parents to prepare healthy meals and use healthy feeding practices, which will improve children's diets and ultimately their health.

Primary Outcome

HEI-2015 scores will be calculated from twenty four hour recall data (two of them which are combined and scored per 1000 kcal or as a % of intake per NCI scoring guidelines). HEI was designed to measure diet quality in terms of how well diets conform to the 2015 Dietary Guidelines for Americans. The total HEI score represents the sum of 12 components scores (minimum component can be 0 and maximum component score shown in parentheses for each), including total fruit (5), whole fruit (5), total ve

Interventions

  • BEHAVIORAL Healthy Feeding, Healthy Eating
  • BEHAVIORAL Reading Readiness

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2019-07-24
Est. Completion 2021-04-12
Phase NA
University of Rhode Island

29 total trials

What the finished NCT03923491 record still lists

NCT03923491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Healthy Feeding, Healthy Eating is the first listed.

NCT03923491 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03923491 about?

NCT03923491 is a clinical study titled "A Home-based Intervention to Improve the Diet Quality of Preschoolers". U.S. children eat too little fruits and vegetables and whole grains, and too many energy dense foods, dietary behaviors associated with increased morbidity from cardiovascular diseases. Parents play a key role in shaping their child's diet and best practices suggest that parents should involve child...

What is the current status of trial NCT03923491?

This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2019-07-24. Estimated completion is 2021-04-12.

What interventions are being tested in trial NCT03923491?

The interventions under investigation include: Healthy Feeding, Healthy Eating (BEHAVIORAL), Reading Readiness (BEHAVIORAL).

Who is sponsoring clinical trial NCT03923491?

This trial is sponsored by University of Rhode Island, which has 29 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03923491's enrollment target sits among peer trials

63 1157th of 2000 higher than 844 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03923491, the US trial registry maintained by the National Library of Medicine. NCT03923491 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.