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Completed

NCT Number: NCT05085041

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University Center for Early Head Start

Lubbock, Texas, 79403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: HOPE

Primary outcomes

  1. Changes in Fruit and Vegetable Intake (Unit: Servings)

    Time frame: Changes in Fruit and Vegetable Intakes by toddlers from baseline to 3 months

    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.

  2. Changes in Skin Carotenoid Score (Unit: nm)

    Time frame: Changes in Skin Carotenoid Scores by parents and toddlers from baseline to 3 months

    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.

  3. Changes in Times Being Physically Active (Unit: Minutes)

    Time frame: Changes in Times Being Physically Active by toddlers from baseline to 3 months

    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.

Secondary outcomes

  1. Changes in Parental Nutritional Knowledge Score (Unit: Numerical Score)

    Time frame: Changes in Parental Nutritional Knowledge Scores from baseline to 3 months

    The investigators will use a multiple-choice questionnaire to test if there is any change in parental nutritional knowledge after the intervention.

  2. Changes in Parental Attitude Score (Unit: Numerical Score)

    Time frame: Changes in Parental Attitudes Scores from baseline to 3 months

    A 13-item, responding to a 5-point Likert scale, will be assessed parental attitudes towards healthy eating and physical activity.

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

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

    The self-efficacy questionnaire, consisting of 8 items, will be used to assess parental self-efficacy in feeding toddlers and mealtime interaction.

  4. Changes in Parental Feeding Practices (Unit: Numerical Score)

    Time frame: Changes in Parental Feeding Practices Scores from baseline to 3 months

    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.

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study 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

Acronym: HOPE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2021
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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