NCT03656146

Brief Summary

This study compares food insecurity disclosure rates in face-to-face interviews versus electronic formats, and explores caregiver preferences regarding screening modality and location, in a large, urban pediatric emergency department. Half of the participants were screened for food insecurity verbally, face-to-face by a research assistant, and half of the participants were screened electronically by a tablet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,818

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

August 28, 2018

Last Update Submit

March 14, 2023

Conditions

Keywords

social determinants of healthfood insecurityscreeningpediatrics

Outcome Measures

Primary Outcomes (1)

  • Presence of Food Insecurity

    Affirmative response to either of the two, validated screening questions for food insecurity. Investigators measured food insecurity using the validated two-question "Hunger Vital Sign" screening tool, with yes/no responses. These two questions are: within the past 12 months "we worried whether our food would run out before we got money to buy more" and "the food we bought just didn't last and we didn't have money to get more."

    12 months

Secondary Outcomes (2)

  • Preferred Screening Modality

    4 weeks

  • Comfort level with screening location

    4 weeks

Study Arms (2)

Tablet Screening

ACTIVE COMPARATOR

Food insecurity screening conducted via electronic tablet

Other: Food Insecurity Screening Tablet

Verbal Screening

ACTIVE COMPARATOR

Food insecurity screening conducted via verbal face-to-face interview

Other: Food Insecurity Screening Verbal

Interventions

The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening

Tablet Screening

The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening

Verbal Screening

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • Adult caregiver accompanying pediatric patient in the Children's Hospital of Philadelphia (CHOP) emergency department

You may not qualify if:

  • Patient (child) in critical condition
  • Patient (child) \>18 years of age
  • Previously enrolled in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 4, 2018

Study Start

May 15, 2017

Primary Completion

November 28, 2017

Study Completion

January 18, 2018

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations