- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07224412
A Digital Intervention to Promote Preschool Nutrition and Activity: The eHEROs Study
Utilizing Digital Health Approaches to Promote Early Childhood Healthy Eating and Activity Behaviors
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura L Bellows, PhD, MPH, RDN
- Phone Number: 607-253-2173
- Email: laura.bellows@cornell.edu
Study Locations
-
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New York
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Ithaca, New York, United States, 14853-0001
- Recruiting
- Cornell University
-
Contact:
- Laura Bellows
- Phone Number: 607-253-2173
- Email: laura.bellows@cornell.edu
-
Contact:
- Email: laura.bellows@cornell.edu
-
Principal Investigator:
- Laura L Bellows, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must have a preschool-aged child (3-5 years) with no disabilities or conditions that impact typical eating and activity behaviors.
- Adult participants must have access to a smartphone, reliable internet at home, and can make video calls.
Exclusion Criteria:
- Adults who do not have a child aged 3-5 or child has a disability/condition that impact typical eating and activity behaviors.
- Technology access is limited.
- Adults who read, write or speak a language other than English.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: KnowHow Program
Families will participate in the 10-week KnowHow program and will receive/participate in 1) a custom mobile application (app), 2) virtual group discussions, and 3) child-centered support materials
|
The KnowHow intervention is a 10-week program that provides parent education on the topics of mindful parenting, healthy eating, and physical literacy.
The intervention consists of three components: 1) a custom mobile application (app), 2) virtual group discussions, and 3) child-centered support materials mailed to participating families.
(1) The KnowHow app will provide parent education using a variety of modalities The 'know' will provide parents with the core information on mindful parenting, healthy eating, and physical literacy, and the 'how' will give strategies to incorporate the information into daily routines and activities.
To facilitate the transition from the 'know' to 'how', the app will have a 'Kid Zone' with content to engage in activities with the preschooler.
KnowHow app content will be divided into five modules that include A) lessons (text, audio, video), B) activities, and C) assessments.
(2) During the 10-week intervention, participants will also meet via Zoom for
Other Names:
|
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No Intervention: Wait List
Families will not receive any intervention during the 10-week study.
Families will receive access to the KnowHow app only for 10 weeks at the conclusion of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment
Time Frame: Baseline (week 0)
|
Number of completed interest forms resulting in enrollment.
|
Baseline (week 0)
|
|
Retention
Time Frame: 10 weeks
|
Proportion of intervention activities (e.g., app modules and assessments) completed.
|
10 weeks
|
|
Usability
Time Frame: Post-Intervention (week10)
|
Mean scores using the System Usability Scale (SUS) to estimate ease of use, complexity, confidence in using, and likelihood of use (scale 0-5, with higher scores indicating higher rankings of usability)
|
Post-Intervention (week10)
|
|
Acceptability
Time Frame: 10 weeks
|
Mean ratings of information helpfulness, goal setting, liking of the program, willingness to recommend, and desire for additional information (scale 0-5, with higher scores indicating higher acceptibility)
|
10 weeks
|
|
Digital Engagement
Time Frame: Post-Intervention (week10)
|
Percentage of participants engaging with the app (i.e., engagement by topic, features, and temporal patterns), and by dosage (i.e., completion rates of modules and within-app activities).
|
Post-Intervention (week10)
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Intention to sustain
Time Frame: Post-intervention (week 10)
|
Qualitatively capture, via individual interviews, intervention strategies relating to target behaviors which were implemented or adopted.
|
Post-intervention (week 10)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindful Parenting
Time Frame: Baseline (week 0) and Post-Intevention (week 10)
|
Mean scores using the Interpersonal Mindfulness in Parenting survey (I-MP) will assess five constructs of mindful parenting: parent/caregiver listening with full attention, emotional awareness of self and child, self-regulation, compassion of self and child, non-judgmental acceptance of self and child).
Scale, 0-5, with higher scores indicating higher mindful parenting.
|
Baseline (week 0) and Post-Intevention (week 10)
|
|
Parent-Child Feeding Practices
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
|
Mean scores from the Food Parenting Inventory (FPI) will assess Autonomy (encourages exploration of new foods, offers new foods, repeatedly presents new foods) and Control (pressure to eat, food as reward).
Scale, 0-5, with higher scores indicating more positive child feeding practices.
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Baseline (week 0) and Post-Intervention (week 10)
|
|
Physical Activity Parenting Practices
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
|
Mean scores from teh PA Parenting Practices (PAPP) will assess three parenting domains: Structure (nondirective support, supportive expectation, restriction of physical activity inside), Autonomy (autonomy support, guided choice), and Control (coercive control).
Scale, 0-5, with higher scores indicating more positive PA practices.
|
Baseline (week 0) and Post-Intervention (week 10)
|
|
Perceived Parenting Self-Efficacy
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
|
Mean scores of questions adapted from the Generalized Self-Efficacy Scales and will assess the offering of healthy foods, providing physical activity opportunities for their child, and engaging in positive interactions with their child related to healthy eating, physical activity, and modifying the home environment.
Scale, 0-5, with higher scores indicating higher self-efficacy.
|
Baseline (week 0) and Post-Intervention (week 10)
|
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Behavioral capability skills
Time Frame: 10 weeks
|
Means scores of questions adapted from the Feeding Knowledge Questionnaire to assess parent feeding knowledge and misconceptions, and the PLAYshop instrument adapted for use in parents of preschool-age children to assess physical literacy knowledge and confidence.
Scale, 0-5, with higher scores indicating more higher behavioral capability.
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10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Meal Quality (exploratory)
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
|
Measured via food photography, meal quality will be assessed using Healthy Meal Index adequacy score (mean of 3 meals, range 0-55).
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Baseline (week 0) and Post-Intervention (week 10)
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Child Meal Quantity (exploratory)
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
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Measured via food photography, meal quantity will be determined by visual estimation of serving sizes (e.g., 1/4 c.)
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Baseline (week 0) and Post-Intervention (week 10)
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Child's Dietary Intake (exploratory)
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
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Mean scores of children's consumption of foods will be collected using the Dietary Screener Questionnaire (DSQ).
Quantitative estimates of food and nutrient intake (e.g., cups of fruit, vegetables and ounce equivalents of whole grains).
These quantitative estimates will be compared to recommended serving sizes from the Dietary Guidelines of Americans to determine if consumption of food groups is meeting, above or below guidelines.
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Baseline (week 0) and Post-Intervention (week 10)
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Child Fundamental movement skill performance (exploratory)
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
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Mean scores for objective control and locomotor skills will be assessed using Test for Gross Motor Development, 2nd Ed (TGMD-2) scoring protocol.
Each skill is scored on a scale of 0-1 with subscale ranges of 0-6 for locomotor skills and 0-5 for object control skills.
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Baseline (week 0) and Post-Intervention (week 10)
|
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Child Physical Activity Opportunities (exploratory)
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
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Mean scores of opportunities for structured and unstructured PA will be assessed (scale, 0-5, with higher scores indicating more positive opportunities).
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Baseline (week 0) and Post-Intervention (week 10)
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Home Food Environment (exploratory)
Time Frame: Baseline (week 0) and Post-Intervention (week 10)
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Frequency of the availability of Fruit, Convenience Foods, Beverages and Whole Grains; Physical activity equipment will be assessed via the HomeIDEAv3 instrument.
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Baseline (week 0) and Post-Intervention (week 10)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura L Bellows, PhD, Cornell University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB0010703
- 2021-68015-34557 (Other Grant/Funding Number: USDA NIFA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Any unique resources will be made available immediately after publication. Procedures to protect the privacy of health data of individuals will be implemented to ensure HIPPA privacy standards are met. After the publication of outcome data, it will be made available to individuals who have IRB approval. The final dataset will be de-identified prior to sharing.
We will insure that data and associated documentation is available to users only under a data sharing agreement that states a commitment to: 1) using the data only for research purposes, 2) securing the data using appropriate technology protection; and 3) destroying the data after analyses are completed.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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