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

NCT ID: NCT03923491

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-24
• Study Completion Date: 2021-04-12

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.

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.

Conditions

Diet Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Healthy Feeding, Healthy Eating

Intervention Type: BEHAVIORAL

Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers

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.

Group Type: ACTIVE_COMPARATOR

Reading Readiness

Intervention Type: BEHAVIORAL

Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children

Interventions

Healthy Feeding, Healthy Eating

Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers

Intervention Type: BEHAVIORAL

Reading Readiness

Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: collaborator

University of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Alison Tovar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rhode Island

Kingston, Rhode Island, United States

Countries

United States

References

Fox K, Gans K, McCurdy K, Risica PM, Jennings E, Gorin A, Papandonatos GD, Tovar A. Rationale, design and study protocol of the 'Strong Families Start at Home' feasibility trial to improve the diet quality of low-income, ethnically diverse children by helping parents improve their feeding and food preparation practices. Contemp Clin Trials Commun. 2020 Jun 16;19:100583. doi: 10.1016/j.conctc.2020.100583. eCollection 2020 Sep.

Reference Type: BACKGROUND

PMID: 32637721 (View on PubMed)

McCurdy K, Gans KM, Risica PM, Fox K, Tovar A. Food insecurity, food parenting practices, and child eating behaviors among low-income Hispanic families of young children. Appetite. 2022 Feb 1;169:105857. doi: 10.1016/j.appet.2021.105857. Epub 2021 Dec 10.

Reference Type: BACKGROUND

PMID: 34896386 (View on PubMed)

Provided Documents

Document Type: Study Protocol: Data Collection Protocol

View Document

Document Type: Study Protocol: Intervention Delivery Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

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Other Identifiers

1R34HL140229-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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