NCT00632346

Brief Summary

The purpose of this study is to determine if there is an association between a variety of adverse childhood experiences and overweight and obesity. The adverse childhood experiences that will be examined include childhood abuse (physical, emotional, sexual), childhood neglect (physical, emotional), and household dysfunction (domestic violence, parental marital discord, and household members with a history of substance abuse, mental illness, and criminal behavior). Because this study will be performed at a military treatment facility, additional military unique experiences to include frequent residential mobility and parental deployment will also be examined. Hypotheses/Research Questions: Overweight and obese young adults are more likely to report having experienced adverse childhood experiences and household dysfunction than their peers of normal weight. In addition, the more severely overweight or obese the patient, the more likely the patient is to report a higher number of previous adverse childhood experiences. Thus, there is a graded relationship between the severity of overweight/obesity and the number of adverse childhood experiences.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
Last Updated

March 10, 2008

Status Verified

February 1, 2008

Enrollment Period

5 months

First QC Date

February 29, 2008

Last Update Submit

March 7, 2008

Conditions

Keywords

childhood abuseoverweightobesityBMI as a young adultchildhood physical abusechildhood emotional abusechildhood sexual abusechildhood physical neglectchildhood emotional neglectchildhood witnessing of domestic violenceparental marital discordhousehold members with substance abusehousehold members with mental illnesshousehold members with criminal behaviorcumulative adverse childhood experiences

Outcome Measures

Primary Outcomes (1)

  • Relationship between reported prior Adverse Childhood Experiences (individual and cummulative) to weight status (underweight, normal weight, overweight, obese) in young adults (18-23 years-old) in a military dependent population.

    BMI at one visit at the time of enrollment

Secondary Outcomes (2)

  • prevalence of underweight, normal weight, overweight, and obese in the population of 18-23 year-old military dependent patients

    BMI at time of enrollment

  • prevalence of reported prior Adverse Childhood Experiences (individual and cummulative) reported by the population of 18-23 year-old military dependents

    results of survey at time of enrollment

Study Arms (1)

1 group

200 patients presenting to the Adolescent Medicine Clinic at Brooke Army Medical Center between the ages of 18 and 23 years-old.

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients between the ages of 18 and 23 years of age who present to the Brooke Army Medical Center Adolescent Medicine Clinic(regardless of their gender, height, weight, blood pressure, reason for appointment, or health status)

You may qualify if:

  • All patients presenting to the Adolescent Medicine clinic during the study period,
  • both male and female,
  • between the ages of 18 and 23 years of age,
  • will be identified for possible participation in the study regardless of their health status, race, or body habitus.

You may not qualify if:

  • Only patients 18 years of age or older will be identified for possible participation in this study because such patients are not minors and could participate without parental consent.
  • In addition, the questions from the questionnaire obtained from the Centers for Disease Control have only been assessed for reliability and validity in patients older than 18 years of age, and the questions are worded with the beginning phrase "During the first 18 years of life…"
  • Lastly, requiring parental consent when inquiring about household dysfunction and a prior history of abuse would likely result in selection bias based on a higher number of subjects declining to participate. It is likely that more subjects will answer the questions truthfully if parental consent for participation is not required.
  • The Brooke Army Medical Center Adolescent Medicine Clinic generally only serves patients 12-23 years of age. Therefore, patients above the age of 23 years will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adolescent Medicine Clinic, Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Heather L Elizondo Vega, MD

    U.S. Army, Brooke Army Medical Center, Adolescent Medicine Clinic, Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 10, 2008

Study Start

September 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 10, 2008

Record last verified: 2008-02

Locations