Mobile behavioral health in Eating Behaviors - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Eating Behaviors

Intervention / Treatment

Behavioral: Mobile behavioral health

Detailed Description

This study will be observational. Recruitment of 100, 6-10-year-old child-parent dyads from rural Appalachia will use approved advertisements on popular internet sites, mom's groups, Facebook, family-oriented periodicals, online recruiting databases (e.g., Research Match) and paid recruitment (Build Clinical, Meta). Interested parents will complete an initial screening via REDCap to determine if families fit the inclusion and exclusion criteria. Prior to answering screening questions, the parents will be provided with a brief study description. Once parents complete the screening questions, they will be scheduled for an Onboarding videoconference call (e.g., Zoom). At the Onboarding session, a parent will sign a full study Consent form and children will provide written Assent. Parents will then select locations on a map to mark their home address and any locations they commonly shop for foods. Researchers will also help parents install the Wear-IT app on their own smartphone devices and complete a training protocol. After the Onboarding session, parents will complete an online survey on demographic information, parental feeding practices via the Child Feeding Questionnaire and the Family Food Behavior Survey, both of which have been validated. Neighborhood Impact on Kids Study questionnaire will be used to assess family food rules and parents' perception of the neighborhood food environment. Child appetitive traits will be assessed using the Children's Eating Behavior Questionnaire, which has been validated against laboratory food intake. Lastly, parent eating behavior will be assessed using the validated Three Factor Eating Questionnaire. Parents will use the Wear-IT app for three weeks. During the 3-week period, parents will receive ecological momentary assessment (EMA) prompts and just-in-time adaptive intervention messages related to the three primary diet-related health behavior categories: 1) home food environment; 2) home meals; and 3) food shopping. Specifically, participants will complete weekly home food inventories and meal videos, at-home meal surveys 3 times a week, and daily end-of-day check-in surveys. They will also be prompted to take a picture of their receipt whenever they go to an identified food shopping location. Parents will rate the acceptability of each of the messages sent via Wear-IT using the Intervention Appropriateness Measure. Upon completion of the 3-week Wear-IT period, parents will repeat the online questionnaire they completed after on-boarding. They will also rate the acceptability and validity of Wear-IT's EMA using the Acceptability of Intervention Measure and the Feasibility of Intervention Measure, respectively.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Alaina Pearce, PhD
Phone Number: 814-863-2120
Email: azp271@psu.edu

Study Locations

United States
- Pennsylvania
  - State College, Pennsylvania, United States, 16802
    - Penn State University
    - Contact:
      
      Alaina Pearce, PhD
      
      Phone Number: 814-863-2120
      
      Email: azp271@psu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will include children and their parents who live in Appalachia.

Description

Inclusion criteria:

In order to be enrolled, children must:

Speak fluent English
Be of good health based on parental self-report
have no learning (e.g., dyslexia) or neurodevelopmental disabilities (e.g., ADHD)
between the ages of 6-10 years-old at enrollment.
Live in the Appalachian region of the United States.

Parents will be included if:

Speak fluent English
They report being the primary parent responsible for feeding decisions
Have a smart-phone device that has an active phone service plan
Live in the Appalachian region of the United States.

Exclusion criteria:

Children would be excluded if they:

Do not speak fluent English
are <6 years old or > 10 years-old at baseline
have any of the following: a learning disability, ADD/ADHD, language delays, autism or other neurological or psychological conditions
have a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing's syndrome, Down's syndrome, food allergies, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy.
Do not live in the Appalachian region of the United States.

Parents will be excluded if:

Do not speak fluent English
They report not being the primary parent responsible for feeding decisions
Does not have a smart-phone device with an active phone service plan
Do not live in the Appalachian region of the United States.

Secondary research subjects (other family members who may appear in video and consent to incidental recording): will be excluded if:

• They did not agree to have their identifiable images included in the home meal video

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: ECOLOGIC_OR_COMMUNITY
Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability Time Frame: immediately after the 3-week intervention period	The Acceptability of Intervention Measure will assess the acceptability of the intervention. No summary score/scoring available. Range from Completely disagree to completely agree.	immediately after the 3-week intervention period
Intervention Appropriateness Time Frame: immediately after the 3-week intervention period	The Intervention Appropriateness Measure will asses the appropriateness of the intervention. No summary score/scoring available. Range from Completely disagree to completely agree.	immediately after the 3-week intervention period
Intervention Satisfaction Time Frame: immediately after the 3-week intervention period	The Satisfaction Survey will assess the participants' satisfaction with the intervention. Scored from 1 (Not at all) to 5 (Absolutely).	immediately after the 3-week intervention period
Intervention Feasibility Time Frame: immediately after the 3-week intervention period	The Feasibility of Intervention Measure will assess participants' perception of the feasibility of this type of intervention. No summary score/scoring available. Range from Completely disagree to completely agree.	immediately after the 3-week intervention period
Daily appropriateness of messages Time Frame: end of each intervention day at time chosen by participant	Ecological momentary assessment surveys will be completed daily to assess the appropriateness of each intervention message received that day. No summary score/scoring available. Range from Completely disagree to completely agree.	end of each intervention day at time chosen by participant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Food Environment Time Frame: Once each week of the 3-week intervention period on a day chosen by parents	Fulkerson Home Food Environment survey will be complete weekly for the 3 weeks of the study to assess types of food available in the home	Once each week of the 3-week intervention period on a day chosen by parents
Child Eating Behaviors Time Frame: Once each week of the 3-week intervention period on a day chosen by parents	Video recordings of children eating at home will be coded to extract various child eating behavior metrics such as bite rate.	Once each week of the 3-week intervention period on a day chosen by parents
Home Meal Information Time Frame: end of day after receipt of intervention messaging throughout the day	As part of a daily EMA surveys, parent will report on home meal environments and participants in home meals.	end of day after receipt of intervention messaging throughout the day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

October 16, 2026

First Submitted That Met QC Criteria

November 10, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)