Clinical trial NCT03923491: A Home-based Intervention to Improve the Diet Quality of Preschoolers
Official title: A Home-based Video and Motivational Interviewing Intervention to Improve Preschoolers Diet Quality and Parental Food Parenting Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: Brown University
name: University of Connecticut
First posted: 2019-04-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention vs. Attention Control
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: HEI-2015 Total and Component Scores
timeFrame: Healthy Eating Index Scores at study completion (6 months)
Secondary outcomes:
measure: Food Parenting Practices
timeFrame: Food Parenting Practices at study completion (6 months)
Other outcomes:
measure: Home Food Availability Change
timeFrame: Changes in Home Food Inventory Scores between baseline and study completion at 6 months
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
References:
citation: 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.
citation: 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.