- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03923491
A Home-based Intervention to Improve the Diet Quality of Preschoolers
A Home-based Video and Motivational Interviewing Intervention to Improve Preschoolers Diet Quality and Parental Food Parenting Practices
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alison Tovar, PhD
- Phone Number: 4018749855
- Email: alison_tovar@uri.edu
Study Contact Backup
- Name: Karen McCurdy, PhD
- Phone Number: 40187-5960
- Email: kmccurdy@uri.edu
Study Locations
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Rhode Island
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Kingston, Rhode Island, United States, 02881
- University of Rhode Island
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
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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.
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Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HEI-2015 Total and Component Scores
Time Frame: Healthy Eating Index Scores at study completion (6 months)
|
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.
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Healthy Eating Index Scores at study completion (6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Parenting Practices
Time Frame: Food Parenting Practices at study completion (6 months)
|
The intervention effects on 14 subscales of the Food Parenting Inventory were used as secondary outcome measures: 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).
We also use one subscale of the Comprehensive Feeding Practices Questionnaire: Healthy Eating Guidance (P).
All scales are rated on a 5-point Likert scale ranging from 1 (min) to 5 (max).
Higher subscale scores indicate greater use of that child feeding practice.
We have noted which practice has more positive/desirable practices with a (P) and more negative/not desired sub-scales have an (N) with higher scores.
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Food Parenting Practices at study completion (6 months)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Changes in Home Food Inventory Scores between baseline and study completion at 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R34HL140229-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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