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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03923491

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted August 5, 2019

Study Description

Brief 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.

  • Condition or Disease:Diet Modification
  • Intervention/Treatment: Behavioral: Healthy Feeding, Healthy Eating
    Behavioral: Reading Readiness
  • Phase: N/A
Detailed Description

There is a critical need for primary prevention interventions to help parents shape children's dietary behaviors early in life. These interventions need to be convenient for busy, working families and tailored to children's needs and the family environment. Although there have been several interventions among preschool aged children to improve dietary behaviors, none have 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. The proposed research will develop and pilot-test the feasibility, acceptability and preliminary efficacy of a novel home-based intervention to improve the diet quality and family food environment of high-risk preschool age, low-income, ethnically diverse children. This research will build upon previous research including a pre-pilot intervention with 15 mother-child dyads which included two home visits: the first visit included a meal-recording and the second included a motivational interviewing (MI) session using coded video clips from the meal-recording as feedback on the parents' feeding practices. All families were retained and significant improvements in several parental feeding practices were found. Based on lessons learned in the pre-pilot, the proposed 6-month intervention will include home visits by a community health worker (CHW) trained in MI, enhanced by adding several innovative components. The home visits will include in-home cooking demonstrations; tailored text-messages, mailed materials and CHW phone calls. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors. These strategies are expected to increase parental knowledge, self-efficacy, and motivation for serving easy, inexpensive healthy foods in the home, leading to increased child exposure to more healthy and varied foods, improvements in parental feeding practices, and ultimately, improvements in child diet quality. The specific aims are as follows: Aim 1: To conduct focus groups with 40 ethnically diverse low-income parents of preschoolers (2-5 years) to inform the adaptation and development of the enhanced intervention. Aim 2: To conduct a pilot randomized controlled trial with 60 parent-child pairs (30 intervention/30 control) from ethnically diverse, low-income families with preschoolers to: Aim 2.1 Determine the feasibility and acceptability of the enhanced intervention. Aim 2.2 Determine the preliminary efficacy of the enhanced intervention on changes in children's diet quality (primary outcome) and parental feeding practices and availability of healthy foods in the home (secondary outcomes) and calculate effect sizes for a future randomized controlled trial (RCT). The investigators hypothesize that the intervention will be feasible and acceptable to parents and that parent-child pairs randomized to the intervention condition will demonstrate greater improvements in the outcomes after six months compared to the comparison condition (attention control of a school readiness intervention). Exploratory aim: Explore how parents' skills, self-efficacy and intrinsic motivation are related to changes in children's diet quality and parental feeding practices.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Intervention vs. Attention Control
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: A Home-based Video and Motivational Interviewing Intervention to Improve Preschoolers Diet Quality and Parental Food Parenting Practices
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Healthy Feeding, Healthy Eating
The experimental arm will receive three home over the first three months of the intervention.Visits will be conducted by a community health worker (CHW) trained in Motivational Interviewing. The home visits will include video-feedback on a meal; in-home cooking demonstrations; tailored text-messages, and mailed materials. During the last three months of the intervention, CHW will conduct monthly phone calls, together with mailed materials and text messages. The intervention will be tailored for families based on the child's appetitive traits and eating behaviors.
Behavioral: Healthy Feeding, Healthy Eating
Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
Active Comparator: Reading and Readiness
The Reading and Readiness group will receive information on school readiness promotion. Materials will be adapted and delivered by the community health worker (CHW) with a similar dose and schedule as the intervention group (three home visits and three phone calls). During the home visits, the CHW will show a video that models early childhood caregiver-child activities and demonstrates simple methods to interact with their children. They will also send a video of themselves reading with a child, receive text-messages based on these materials as well as the print materials during the last three months of the intervention.
Behavioral: Reading Readiness
Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
Outcome Measures
  • Primary Outcome Measures: 1. Child Diet Quality Change [ Time Frame: Change in Healthy Eating Index Scores between baseline and study completion at 6 months ]
    Healthy Eating Index Change Scores. HEI-2015 scores will be calculated from twenty four hour recall data (two of them). 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 (maximum component score shown in parentheses), including total fruit (5), whole fruit (5), total vegetables (5), green and beans (includes dark green vegetables and cooked, dried beans and peas because intakes of these types of vegetables are furthest from the amounts recommended in the USDA Food Patterns) (5), whole grain (10), dairy (10), total protein food (5), seafood and plant proteins (5), fatty acids (10), refined grains (10), sodium (10) and empty calories (20). Total HEI scores can have a maximum value of 100 which indicates high diet quality.
  • Secondary Outcome Measures: 1. Food Parenting Practices [ Time Frame: Changes in Feeding Practice Subscale Scores b between baseline and study completion at 6 months ]
    We will explore changes to 14 subscales of the Food Parenting Inventory: Encourage try new foods (P), Encourage exploration of new foods (P), Urge child to eat new foods (P), Repeated Presentation of New foods (P), Family meals (P), Regular timing of meals and snacks (P), Inconsistent mealtimes (N), Indifferent feeding (N), Child involvement in food preparation (P), Pressure to Eat (N), Restriction (N), Food as a reward (N), Responsiveness to child's fullness cues (P), Monitoring (P) and one subscale of the Comprehensive Feeding Practices Questionnaire, Healthy Eating Guidance (P). More positive/desirable practices have a (P) and more negative/not desired sub-scales have (N).
  • Other Outcome Measures: 1. Home Food Availability Change [ Time Frame: Changes in Home Food Inventory Scores between baseline and study completion at 6 months ]
    Home Food Inventory Change Scores. Home food inventory (HFI) will be used to assess a wide range of commonly available foods in the home environment. A total healthy food availability score will be created from the following items (fruit- frozen, canned, fresh or dried, vegetables-frozen, fresh or canned, milk, water, whole grains, legumes) with a higher score representing more availability of healthy foods. Scores can range from 0-11. An unhealthy food score will also be created from the following items (Chips, Cakes/Cookies, Candy, Pastries, Juice, Soda, Sports drinks, Sweetened Beverages)- scores can range from 0-8 with higher scores representing availability of unhealthy foods.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 95 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Speak English or Spanish

- Have a child between 2- 5 years of age

- Live with their child most of the time

- Have a phone that is able to video-record

- Be willing to have evening meals video recorded in the home

Exclusion Criteria:

*Has a diagnosed feeding disorder, dietary restrictions, or medical condition that impacts
how they feed their child.

Contacts and Locations
Contacts

Contact: Alison Tovar, PhD 4018749855 alison_tovar@uri.edu

Contact: Karen McCurdy, PhD 40187-5960 kmccurdy@uri.edu

Locations

United States, Rhode Island
University of Rhode Island
Kingston

Sponsors and Collaborators

University of Rhode Island

Brown University

University of Connecticut

More Information
  • Responsible Party: University of Rhode Island
  • ClinicalTrials.gov Identifier: NCT03923491 History of Changes
  • Other Study ID Numbers: 1R34HL140229-01A1
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: August 5, 2019
  • Last Verified: August 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No