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

NCT03923491 | Completed Results

• 1 other identifier: 1R34HL140229-01A1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (1)

• HEI-2015 Total and Component Scores

  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 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) added sugar (10), saturated fat (10). Higher scores reflect better outcomes.

  Healthy Eating Index Scores at study completion (6 months)

Secondary Outcomes (1)

• Food Parenting Practices

  Food Parenting Practices at study completion (6 months)

Other Outcomes (1)

• Home Food Availability Change

  Changes in Home Food Inventory Scores between baseline and study completion at 6 months

Study Arms (2)

Healthy Feeding, Healthy Eating

EXPERIMENTAL

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

Reading and Readiness

ACTIVE COMPARATOR

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

Interventions

Healthy Feeding, Healthy Eating BEHAVIORAL

Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers

Healthy Feeding, Healthy Eating

Reading Readiness BEHAVIORAL

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

Reading and Readiness

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rhode Island: lead
• Brown University: collaborator
• University of Connecticut: collaborator

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Related Publications (2)

• 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.

  PMID: 32637721 BACKGROUND

• 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.

  PMID: 34896386 BACKGROUND

MeSH Terms

Interventions

Diet, Healthy

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

In consideration of our study findings, there are some limitations worth noting. First, given the COVID-19 pandemic, several modifications had to be made to the intervention and data collection procedures. We were not able to test our initial fully home-based model and had to modify our secondary outcome of observing changes in the home food environment.

Results Point of Contact

• Title: Dr. Alison Tovar
• Organization: Brown University School of Public Health

alison_tovar@brown.edu

401-863-7327

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention vs. Attention Control

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: April 22, 2019
• Study Start: July 24, 2019
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-12

Locations

US (1)