NCT02265185

Brief Summary

Childhood obesity is a major area of concern for health care and public health. Overweight children are more likely overweight and obese adults. Chronic health problems associated with adult obesity are now occurring more frequently in children. Because of the associated health problems and potential for long term struggles with obesity, intervention early in life is essential for addressing the obesity epidemic. Some intervention work in this area has focused on the pediatric primary care setting in order to utilize the influence and credibility of medical providers. Unfortunately, primary care visits are often too short to spend a significant amount of time on issues of diet, weight and nutrition. There has been very little work exploring the potential of alternative care settings, such as the pediatric Emergency Department (ED) in addressing childhood obesity. While provider time is also limited in the ED, there is often a considerable amount of downtime during emergency department visits that could be valuable time for patient and parent education. There may also be an opportunity to reach parents and children in the ED who do not regularly utilize primary care. In order to explore the possibility of pediatric obesity interventions in Children's Pediatric Emergency Department, we will need to measure the prevalence of obesity in the population that utilizes the Children's ED. The height of patients seen in the ED is not routinely measured, which makes calculating BMI to determine obesity impossible. This study, establishing the prevalence of obesity in Children's Emergency Department will lay the groundwork for future work addressing obesity in the ED.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

October 9, 2014

Last Update Submit

November 17, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Obesity

    Prevalence in Children's ED will be compared to prevalence in the general pediatric population using previously established national data

    1 year

Secondary Outcomes (1)

  • Associations between obesity and primary diagnosis

    1 year

Study Arms (1)

ED Patients

Children aged 2-10 visiting the Emergency Department.

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients (aged 2-10) visiting the Children's EDs, who are triaged level 3-5, when a study RA is on duty will be eligible for the study. We have selected the 2-10 year old patient population for this study as the early grade school years are a critical time to intervene before unhealthy lifestyle habits are established, and this age group provides a unique window of opportunity in which to utilize parent and child interaction.

You may qualify if:

  • Emergency Severity Index (ESI) Triage levels 3-5
  • Patient between 2 and 10 years of age (inclusive)
  • Parent able to consent

You may not qualify if:

  • \. Transferred patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis and Saint Paul, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gretchen Cutler, PhD

    Children's Hospitals and Clinics of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 15, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations