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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00632346
Other study ID # C.2007.160
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 29, 2008
Last updated March 7, 2008
Start date September 2007
Est. completion date February 2008

Study information

Verified date February 2008
Source Brooke Army Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

Previous studies have clearly demonstrated that there is an association between childhood adversities and a variety of eating and weight problems. The research can be extended by assessing the cumulative effects of adverse childhood experiences on the severity of overweight and obesity rather than focusing on individual categories of events. In addition, we can learn much by extending the research to include all overweight and obese patients, not just those who have a known underlying comorbid psychiatric disorder such as bulimia nervosa or binge eating disorder.

Lastly, the research on obesity and adverse childhood experiences should be extended to include younger subjects because obesity is now a public health problem of epidemic proportion in the United States, and it is now affecting younger and younger individuals.

The study proposed in this protocol will accomplish the goals of 1) assessing the cumulative effects of adverse childhood experiences, 2) assessing the association of these events with varying degrees of overweight and obesity, and 3) assessing this association in a younger population than that previously examined.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 23 Years
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

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 lifeā€¦"

- 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.

- Therefore, inclusion of younger patients would be a detriment to the scientific merit of the study, thus patients younger than age 18 will be excluded.

- 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.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Adolescent Medicine Clinic, Brooke Army Medical Center Fort Sam Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary prevalence of underweight, normal weight, overweight, and obese in the population of 18-23 year-old military dependent patients BMI at time of enrollment No
Secondary 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 No
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