Eating BehaviorHOPENCT05085041
Healthy Online Parental Education Project to Increase Fruit and Vegetable Intake and Active Playtime Among Toddlers
A study testing Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE) in people with Eating Behavior, run by Texas Tech University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 18 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University Center for Early Head Start
Lubbock, Texas, 79403
About this study
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
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.
Read the detailed 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.
- Conditions
- Eating Behavior
- Being tested
- Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)
- Keywords
- Child Nutrition, Carotenoid Levels, Obesity, Feeding Practice, Child and Maternal Nutrition, Screen Time, Mixed-Methods Research
- Medical subject headings
- Feeding Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)Behavioural
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
The investigators will use a multiple-choice questionnaire to test if there is any change in parental nutritional knowledge after the intervention.
Measured: Changes in Parental Nutritional Knowledge Scores from baseline to 3 months
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.
Measured: Changes in Parental Attitudes Scores from baseline to 3 months
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.
Measured: Changes in Parental Self-Efficacy Scores from baseline to 3 months
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.
Measured: Changes in Parental Feeding Practices Scores from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start5 Oct 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilna Oldewage-Theron, PhD, Study chair, Texas Tech UniversityHyunjung Lee, MS, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085041
- Sponsor's protocol ID
- IRB2021-505
- Acronym
- HOPE
- Status last verified
- Oct 2022
- First submitted
- 13 Sep 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with an academic interest in community nutrition. Data shared will be coded with no Protected Health Information (PHI) included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05085041
- Acronym / sponsor ID
- HOPE / IRB2021-505
- Conditions
- Eating Behavior
- Keywords
- Child Nutrition, Carotenoid Levels, Obesity, Feeding Practice, Child and Maternal Nutrition, Screen Time, Mixed-Methods Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 20 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE)Also: HOPEThe 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). | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
4 secondary outcomes
Changes in Parental Nutritional Knowledge Score (Unit: Numerical Score)
Time frame: Changes in Parental Nutritional Knowledge Scores from baseline to 3 months
Changes in Parental Attitude Score (Unit: Numerical Score)
Time frame: Changes in Parental Attitudes Scores from baseline to 3 months
Changes in Parental Self-Efficacy Score (Unit: Numerical Score)
Time frame: Changes in Parental Self-Efficacy Scores from baseline to 3 months
Changes in Parental Feeding Practices (Unit: Numerical Score)
Time frame: Changes in Parental Feeding Practices Scores from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with an academic interest in community nutrition. Data shared will be coded with no Protected Health Information (PHI) included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilna Oldewage-Theron, PhD study chair
Texas Tech University
Hyunjung Lee, MS principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Component eHealth Intervention, namely Healthy Online Parental Education (HOPE) in people with Eating Behavior, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fruit and Vegetable Intake (Unit: Servings) (time frame: Changes in Fruit and Vegetable Intakes by toddlers from baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.