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

NCT05085041 | Completed

• 1 other identifier: IRB2021-505
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Behavior

Keywords

Child Nutrition; Carotenoid Levels; Obesity; Feeding Practice; Child and Maternal Nutrition; Screen Time; Mixed-Methods Research

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Changes in Parental Nutritional Knowledge Score (Unit: Numerical Score)

  Changes in Parental Nutritional Knowledge Scores from baseline to 3 months

• Changes in Parental Attitude Score (Unit: Numerical Score)

  Changes in Parental Attitudes Scores from baseline to 3 months

• Changes in Parental Self-Efficacy Score (Unit: Numerical Score)

  Changes in Parental Self-Efficacy Scores from baseline to 3 months

• Changes in Parental Feeding Practices (Unit: Numerical Score)

  Changes in Parental Feeding Practices Scores from baseline to 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

The participants in this group will receive 8 sessions of a multi-component online education intervention. The education curriculum will be focused on addressing evidence-based healthy habits that are related to preventing childhood obesity: more vegetables and fruits, less screen time, and more physical activity. Topics may include age-appropriate nutrition and eating, picky eating, positive parental feeding practices, active playtime, and screen time. Strategies for eating healthy on a budget will be also provided to the participants. The intervention will incorporate multi-component as follow: instructional YouTube videos, online cooking activities, reminder text messages with key information, and telephone consultation. Each session will include a lifestyle component regarding eating, feeding, and physical activity, aimed at equipping parents with knowledge and skills to improve fruit and vegetable intake and physical activity levels of young children.

Behavioral: Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)

Control Group

NO INTERVENTION

The participants in the control group will receive no intervention. However, the investigators will provide the control group with a copy of the booklet that includes 2020 USDA dietary guidelines for a healthy diet for young children. This will enable the investigators to see if the multi-component education intervention (stated above) is more effective on behavior changes than the written booklet in the control group.

Interventions

Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE) BEHAVIORAL

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).

Also known as: HOPE

Intervention Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \< 18 years old

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Texas Tech University Center for Early Head Start

Lubbock, Texas, 79403, United States

Location

MeSH Terms

Conditions

Feeding Behavior; Obesity

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilna Oldewage-Theron, PhD

  Texas Tech University

  STUDY CHAIR

• Hyunjung Lee, MS

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research project will include two groups; the intervention and the control groups. Participants will be randomly assigned via block randomization with 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 an online multi-component nutrition intervention. The control group will receive a copy of the booklet that includes dietary recommendations for adults and children, followed by the 2020 U.S. Department of Agriculture Dietary Guidelines.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 20, 2021
• Study Start: October 5, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to Individual Participant Data (IPD) can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal, statistical plan (SAP), and analytic code. For more information or to submit a request, please contact wilna.oldewage@ttu.edu.

Locations

US (1)