Healthy Online Parental Education Project to Increase Fruit and Vegetable Intake and Active Playtime Among Toddlers

Eating Behavior Clinical Trial

— HOPE  

Official title:

Effectiveness of Multi-Component eHealth Intervention, Namely Healthy Online Parental Education (HOPE), to Increase Fruit and Vegetable Consumption and Active Playtime Among Toddlers at Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085041
• Other study ID #: IRB2021-505
• Status: Completed
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: February 18, 2022

Study information

• Verified date: October 2022
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research proposal will be an 8-week randomized control trial (RCT) to examine the efficacy of an eHealth intervention, namely Healthy Parental Online Education (HOPE), on fruit and vegetable intake and active playtime among toddlers enrolled in early head start programs in Lubbock, Texas. Parents with toddlers ages one to three years will be recruited from Early Head Start centers. Written consent forms will be obtained before baseline data collection. The participants will be then randomly assigned to the intervention or control group. The participants in the intervention group will receive a multi-component online nutrition intervention for eight weeks. While the control group will receive a copy of the booklet that includes the 2020 U.S. Department of Agriculture Dietary Guidelines (USDA) for toddlers and adults.

The investigators will measure sociodemographic, parental nutritional knowledge, parental attitude related to healthy eating, parental self-efficacy, parental feeding practices, carotenoids in the skin of both parents and toddlers, three-day food photos, and physical activity and sedentary times of toddlers. This research proposal hypothesizes that there will be significant differences in fruit and vegetable intake and physically active time among toddlers between the intervention and control group from baseline to 3 months. The investigators also hypothesize that there will be significant differences in parental nutrition knowledge, attitude, self-efficacy, and feeding practice between the intervention and control group from baseline to 3 months.

Description:

The investigators will examine the efficacy of an eHealth intervention, namely Healthy Parental Online Education (HOPE), to increase fruit and vegetable intake and active playtime among toddlers enrolled in Early Head Start programs in Lubbock. This study will be an 8-week randomized control trial (RCT). Participants will be randomly assigned to the intervention or control group via block randomization with randomly selected block sizes of 4. Randomization will be conducted by a researcher not involved in data management. The statistical software R version 3.5.1 will be used to determine to generate randomized arm allocation sequences through a fixed seed. The randomization will be stratified by centers. Those allocation sequences will be printed out and individually stored in serially numbered, opaque, sealed envelopes. Participants will be informed of group allocation via opaque and sealed envelopes after the collection of baseline data.

Participants in the intervention group will receive 8 sessions of online multi-component HOPE nutrition intervention. While the control group will receive no intervention, the investigators will provide the control group with a copy of the booklet. This booklet will include basic nutrition recommendations for a healthy diet for adults and children, consistent with 2020 U.S. Department of Agriculture dietary guidelines.

Pre- and post-assessment will be conducted to see changes in variables of interest from baseline (T1), post-intervention (T2), to 3 months (T3). Sociodemographic and anthropometrics of parents and toddlers will be measured at T1. The investigators will also measure carotenoids in the skin of both parents and children using the Veggie Meter (Longevity Link, Salt Lake City, UT) to assess fruit and vegetable intake. Parental nutritional knowledge, attitudes related to healthy eating and activity, feeding practices, and self-efficacy will be assessed using a self-administered questionnaire. The research team will also ask parents to recall the physical activity and sedentary times of toddlers using a self-report survey. Parents will take electronic food photos using their mobile devices for three days to capture the food and beverage intake of toddlers at home. The same measurements and survey will be used at T2 except for variables related to anthropometrics and sociodemographics. Finally, the investigators will only measure the food intake of toddlers, physically active and sedentary times of toddlers, and carotenoid levels of parents and toddlers at T3, using the same methods and procedures mentioned above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having a child between 12 and 36 months of age

• Physically and mentally capable of communicating, reading, and writing in English

• An informed consent form obtained

• Willing and able to attend the intervention

Exclusion Criteria:

• < 18 years old

Related Conditions & MeSH terms

• Eating Behavior

Intervention

Behavioral:
• Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)
The investigators will provide 8 sessions of a multi-component education intervention to the participants in the intervention group. Each session will address parental nutrition knowledge, self-efficacy, and attitudes around feeding, parental modeling of healthy foods, and skill development to increase success in making behavioral changes. The intervention curriculum will be informed by Social Cognitive Theory to help parents guide young children to engage in healthy eating behaviors through modeling (Curriculum Design). The investigators will deliver the intervention using multicomponent to enhance and maximize the learning experiences of the participants for successful behavior changes. The intervention will be comprised of instructional videos, text messages with key information, online cooking activities, and telephone consultation (Modality).

Locations

Country	Name	City	State
United States	Texas Tech University Center for Early Head Start	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Fruit and Vegetable Intake (Unit: Servings)	The investigators will assess changes in fruit and vegetable intakes by toddlers. Electronic photos will be used by parents to record food intake of toddlers. The investigators will manually count and categorize the servings of fruits and vegetables from the food photos.	Changes in Fruit and Vegetable Intakes by toddlers from baseline to 3 months
Primary	Changes in Skin Carotenoid Score (Unit: nm)	The Veggie Meter uses reflection spectroscopy and is an objective, noninvasive measure of the level of carotenoid pigments in a person's skin. Fruits and vegetable intakes as reflected in skin carotenoid scores will be measured by parents and toddlers, using the Veggie Meter.	Changes in Skin Carotenoid Scores by parents and toddlers from baseline to 3 months
Primary	Changes in Times Being Physically Active (Unit: Minutes)	Parents will be asked to report the frequency and duration of different moderate-to-vigorous physical activity (MVPA) and sedentary activities (SA) in which toddlers were engaged during the past weekend at home. The investigators will use a proxy-reported questionnaire to capture and estimate daily minutes of MVPA and SA.	Changes in Times Being Physically Active by toddlers from baseline to 3 months
Secondary	Changes in Parental Nutritional Knowledge Score (Unit: Numerical Score)	The investigators will use a multiple-choice questionnaire to test if there is any change in parental nutritional knowledge after the intervention.	Changes in Parental Nutritional Knowledge Scores from baseline to 3 months
Secondary	Changes in Parental Attitude Score (Unit: Numerical Score)	A 13-item, responding to a 5-point Likert scale, will be assessed parental attitudes towards healthy eating and physical activity.	Changes in Parental Attitudes Scores from baseline to 3 months
Secondary	Changes in Parental Self-Efficacy Score (Unit: Numerical Score)	The self-efficacy questionnaire, consisting of 8 items, will be used to assess parental self-efficacy in feeding toddlers and mealtime interaction.	Changes in Parental Self-Efficacy Scores from baseline to 3 months
Secondary	Changes in Parental Feeding Practices (Unit: Numerical Score)	The Comprehensive Feeding Practices Questionnaire (CFPQ) will be used to capture a broad range of parental feeding practices and behaviors. The investigators will assess if there was any change in positive or negative feeding practices among the participants.	Changes in Parental Feeding Practices Scores from baseline to 3 months