NCT07224412

Brief Summary

The purpose of this pilot study is to assess the feasibility and acceptability of the Know-How program, a 10-week digital intervention for families of young children promoting healthy eating and activity behaviors and environments.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Mar 2027

First Submitted

Initial submission to the registry

October 22, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 4, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

October 22, 2025

Last Update Submit

February 10, 2026

Conditions

Keywords

parentschild, preschoolmHealthmobile appnutritionphysical activity

Outcome Measures

Primary Outcomes (6)

  • Recruitment

    Number of completed interest forms resulting in enrollment.

    Baseline (week 0)

  • Retention

    Proportion of intervention activities (e.g., app modules and assessments) completed.

    10 weeks

  • Usability

    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

    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

    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)

  • Intention to sustain

    Qualitatively capture, via individual interviews, intervention strategies relating to target behaviors which were implemented or adopted.

    Post-intervention (week 10)

Secondary Outcomes (5)

  • Mindful Parenting

    Baseline (week 0) and Post-Intevention (week 10)

  • Parent-Child Feeding Practices

    Baseline (week 0) and Post-Intervention (week 10)

  • Physical Activity Parenting Practices

    Baseline (week 0) and Post-Intervention (week 10)

  • Perceived Parenting Self-Efficacy

    Baseline (week 0) and Post-Intervention (week 10)

  • Behavioral capability skills

    10 weeks

Other Outcomes (6)

  • Child Meal Quality (exploratory)

    Baseline (week 0) and Post-Intervention (week 10)

  • Child Meal Quantity (exploratory)

    Baseline (week 0) and Post-Intervention (week 10)

  • Child's Dietary Intake (exploratory)

    Baseline (week 0) and Post-Intervention (week 10)

  • +3 more other outcomes

Study Arms (2)

KnowHow Program

EXPERIMENTAL

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

Behavioral: KnowHow Program

Wait List

NO INTERVENTION

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.

Interventions

KnowHow ProgramBEHAVIORAL

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

Also known as: eHEROs
KnowHow Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University

Ithaca, New York, 14853-0001, United States

RECRUITING

Related Publications (1)

  • Bellows LL, Oke S, Reyes LI, Carmona BA, Johnson SL. Development of a Digital Parent Intervention to Promote Healthy Eating and Activity in Preschoolers: The eHEROs Study. J Nutr Educ Behav. 2025 May;57(5):450-459. doi: 10.1016/j.jneb.2025.01.008. Epub 2025 Feb 7.

    PMID: 39918513BACKGROUND

Related Links

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Laura L Bellows, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura L Bellows, PhD, MPH, RDN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: parallel pilot feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2025

First Posted

November 4, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After publication
Access Criteria
After the publication of outcome data, data will be made available to individuals who have IRB approval.

Locations