Healthy Weight Poster, Multi-site Study

June 27, 2019 updated by: Wake Forest University Health Sciences

Using a Poster Depicting Healthy Weight to Improve Perception of Weight, a Multi-site Study

This is a multi-site, cross-sectional study of 3-8 year old children and their parents presenting for a well-child check. The investigators are assessing whether a novel, educational, exam room poster can effectively prompt parents to ask their pediatricians about their children's weight status and improve parents' perceptions of their children's weight status.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to evaluate whether a novel, educational, exam room poster can effectively prompt parents to ask their pediatricians about their children's weight status. Exam rooms within clinics will be randomized to either have the poster or not and parents will complete questionnaires assessing weight perception, whether they discussed their child's weight with their physician, and basic demographics. Participants who are in exam rooms with a poster will also answer questions specifically about the poster.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
965

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • UAB Health Center Huntsville
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pediatric Associates of Northern Kentucky
    • North Carolina
      • Durham, North Carolina, United States, 27617
        • Duke Children's Primary Care Brier Creek
      • Durham, North Carolina, United States, 27704
        • Duke Health Center at Roxboro Street
      • Winston-Salem, North Carolina, United States, 27101
        • Downtown Health Plaza
      • Winston-Salem, North Carolina, United States, 27103
        • Ford Simpson Lively and Rice Pediatrics
    • Washington
      • Bellevue, Washington, United States, 98007
        • Public Health Center - Eastgate

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 3-8 years old presenting to pediatric clinic for a well-child visit.
  • Parents of include children who speak English or Spanish and are able to complete a written survey.

Exclusion Criteria:

  • Parents that are <18 years old
  • Children with no documented weight or height for their visit
  • Any medical condition that would affect weight gain or growth such as failure to thrive, congenital heart defect, etc.

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Exam room without poster
All parents will be asked to fill out a questionnaire detailing basic demographic information as well as their perception of their child's weight. Parents who are in exam rooms without posters will be ask to fill out a second short questionnaire after seeing their physician that will ask parents whether they discussed their child's weight status with their physician and whether they believe their own child is: very overweight, overweight, healthy weight, underweight, or very underweight.
Active Comparator: Exam room with poster
All parents will be asked to fill out a questionnaire detailing basic demographic information as well as their perception of their child's weight. Parents who are in exam rooms with posters will be directed to read the poster on the exam room wall. After viewing the poster and after seeing their physician, parents will be ask to fill out a second short questionnaire that will ask parents whether they discussed their child's weight status with their physician, whether this conversation was prompted by the poster, and whether they believe their own child is very overweight, overweight, healthy weight, underweight, or very underweight.
Other: Exam room with poster
This intervention will assess whether a novel educational exam room poster can effectively prompt patients to ask pediatricians about their children's weight status and improve patents' perceptions of their children's weight status.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Poster assessment prompts by questionnaire
Time Frame: End of study - 1 year
Assess whether the poster prompts parents to ask their child's doctor whether their child is a healthy weight.
End of study - 1 year
Parents' perceptions by questionnaire
Time Frame: End of study - 1 year
Assess whether the poster improves accuracy of parents' perceptions of their children's weight status.
End of study - 1 year
Changes in parental perception by questionnaire
Time Frame: End of study - 1 year
Among parents who view the poster, the investigators will assess whether parental perception changes differentially based on parental race/ethnicity, education, or socioeconomic background.
End of study - 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
Eastgate Public Health Center
UAB Huntsville Pediatrics
Pediatric Associates of Northern Kentucky

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Callie L Brown, MD MPH, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00042929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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