OverweightNCT00632346
Relationship of Adverse Childhood Experiences to Overweight and Obesity
An observational study of Overweight and Obesity, run by Brooke Army Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Adolescent Medicine Clinic, Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Relationship of Adverse Childhood Experiences (Childhood Abuse, Neglect, and Household Dysfunction) to the Severity of Overweight and Obesity in Young Adults in a Military Dependent Population.
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.
Read the detailed 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.
- Conditions
- Overweight, Obesity
- Keywords
- childhood abuse, overweight, obesity, BMI as a young adult, childhood physical abuse, childhood emotional abuse, childhood sexual abuse, childhood physical neglect, childhood emotional neglect, childhood witnessing of domestic violence, parental marital discord, household members with substance abuse, household members with mental illness, household members with criminal behavior, cumulative adverse childhood experiences
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 group | 200 patients presenting to the Adolescent Medicine Clinic at Brooke Army Medical Center between the ages of 18 and 23 years-old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: results of survey at time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2008 (estimated)
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Heather L Elizondo Vega, MD, Principal investigator, U.S. Army, Brooke Army Medical Center, Adolescent Medicine Clinic, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632346
- Sponsor's protocol ID
- C.2007.160
- Status last verified
- Feb 2008
- First submitted
- 29 Feb 2008
- Last updated
- 10 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Adverse Childhood Experiences (Childhood Abuse, Neglect, and Household Dysfunction) to the Severity of Overweight and Obesity in Young Adults in a Military Dependent Population.
- ClinicalTrials.gov ID
- NCT00632346
- Acronym / sponsor ID
- C.2007.160
- Conditions
- Overweight, Obesity
- Keywords
- childhood abuse, overweight, obesity, BMI as a young adult, childhood physical abuse, childhood emotional abuse, childhood sexual abuse, childhood physical neglect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (estimated)
- Study completion
- Feb 2008 (estimated)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group | – | –200 patients presenting to the Adolescent Medicine Clinic at Brooke Army Medical Center between the ages of 18 and 23 years-old. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: BMI at one visit at the time of enrollment
2 secondary outcomes
prevalence of underweight, normal weight, overweight, and obese in the population of 18-23 year-old military dependent patients
Time frame: 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
Time frame: results of survey at time of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather L Elizondo Vega, MD principal investigator
U.S. Army, Brooke Army Medical Center, Adolescent Medicine Clinic, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: BMI at one visit at the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2008.