ObesityNCT00127374
Mood and Behavior Changes Among Overweight Adolescent Females
An observational study of Obesity and Depression, run by University of Kentucky at 1 site in United States.
Trial summary
The specific aims of this study are to document the co-existence of depression, low self-esteem, and high-risk behaviors among overweight and at-risk for overweight female adolescents; and decrease the prevalence of high-risk behaviors by improving depressive symptoms/signs and self-esteem through weight management… Read more about this study
- Who is it for?
- Ages 10 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Depression
- What is being tested?
- Dietary and physical activity modifications
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2006
- 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 10 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Girls 10 through 14 years of age who are in good general health and have a BMI in the 85th to 95th percentile or greater than the 95th percentile
- Availability of a parent or guardian to ensure the child attends all monthly clinic visits and who will be available to attend the monthly educational sessions if the child is assigned to the intervention group
Who cannot join
- Cardiac or pulmonary conditions such as cystic fibrosis, congenital heart disease, or other conditions that would impair ability to do fitness testing
- Physical challenges such as deformities that would impair ability to perform physical activities
- Use of medications such as corticosteroids, seizure medication, or other central nervous system (CNS) medications that would interfere with daily physical activity
Trial locations and contacts
1 site in 1 country.
About this study
The specific aims of this study are to document the co-existence of depression, low self-esteem, and high-risk behaviors among overweight and at-risk for overweight female adolescents; and decrease the prevalence of high-risk behaviors by improving depressive symptoms/signs and self-esteem through weight management intervention strategies that encourage long-term mental and physical well being. The proposed research will test the following hypotheses:
- Overweight and at-risk for overweight female adolescents have poor self-esteem that may mask depression and mediate high-risk behaviors; and
- Improved weight perception decreases participation in high-risk behavior secondary to improved self-esteem and depression.
Read the detailed description
How adolescents view (self-concept) and value themselves (self-esteem) may predict future adjustment and success in life. Self-concept comprises assessment of scholastic, athletic and job competence, social acceptance, physical appearance, romantic appeal, behavioral conduct, close friendship, and global self-worth. Self-esteem is the feeling of self-acceptance, goodness, and worthiness. It influences daily activities, motivation and behavior.
Adolescents are very vulnerable to low self-esteem. Generally, boys have higher self-esteem than girls; higher weight students have lower self-concept; and post-menarcheal females have the poorest opinion of their physical appearance. Higher body mass index (BMI) predicts more negative self-concept. Body image and physical appearance contribute to general physical self-concept and self-esteem.
Regardless of race, gender, age, and socioeconomic status individuals are discriminated against on the basis of weight. Weight-based stigmatization influences self-perception and the perceptions of significant others. Sustained low self-esteem may precipitate anxiety, depression, under achievement, poor motivation and inadequate interpersonal relations.
Obese adolescents are stigmatized by peers. They may attempt to protect their self-image by participating in high-risk behaviors. Obese adolescent girls are more likely to report adverse social, educational and psychological correlates than obese boys. Overweight girls, but not overweight boys, manifest more depressive symptoms than their normal-weight peers. Gender differences in clinical depressive syndromes may emerge in early childhood as opposed to puberty as previously thought.
Early stigmatization of obese children may explain their lower self-esteem and greater shame, humiliation, and perceived teasing compared with their nonobese peers. Studies have found increased psychopathology among clinical samples of obese children and demonstrated improvements in psychological functioning with weight loss. Implementing lifestyle changes during early adolescence, ages 10 to 13 years, and middle adolescence, ages 14 to 16 years, may hold the key for preventing obesity and depression.
The study population will consist of approximately 100 overweight or at-risk for overweight female volunteers, 10 - 14 years old.
- Conditions
- Obesity, Depression
- Being tested
- Dietary and physical activity modifications
- Keywords
- Overweight; self-esteem; depression
- Medical subject headings
- Obesity, Depression, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and physical activity modificationsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased body mass index; increased physical activity
Secondary outcomes (1)
Improved self-esteem; improved depression scale score; decreased risk-taking behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startJan 2005
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: withdrawn due to non-response. PI left university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Investigators
- Joan R Griffith, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127374
- Sponsor's protocol ID
- 04-0541-F3R
- Status last verified
- Nov 2016
- First submitted
- 4 Aug 2005
- Last updated
- 8 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood and Behavior Changes Among Overweight Adolescent Females
- ClinicalTrials.gov ID
- NCT00127374
- Acronym / sponsor ID
- 04-0541-F3R
- Conditions
- Obesity, Depression
- Keywords
- Overweight; self-esteem; depression
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: withdrawn due to non-response. PI left university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 5 Aug 2005 (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 specific aims of this study are to document the co-existence of depression, low self-esteem, and high-risk behaviors among overweight and at-risk for overweight female adolescents; and decrease the prevalence of high-risk behaviors by improving depressive symptoms/signs and self-esteem through weight management intervention strategies that encourage long-term mental and physical well being. The proposed research will test the following hypotheses:
- Overweight and at-risk for overweight female adolescents have poor self-esteem that may mask depression and mediate high-risk behaviors; and
- Improved weight perception decreases participation in high-risk behavior secondary to improved self-esteem and depression.
Detailed description
How adolescents view (self-concept) and value themselves (self-esteem) may predict future adjustment and success in life. Self-concept comprises assessment of scholastic, athletic and job competence, social acceptance, physical appearance, romantic appeal, behavioral conduct, close friendship, and global self-worth. Self-esteem is the feeling of self-acceptance, goodness, and worthiness. It influences daily activities, motivation and behavior.
Adolescents are very vulnerable to low self-esteem. Generally, boys have higher self-esteem than girls; higher weight students have lower self-concept; and post-menarcheal females have the poorest opinion of their physical appearance. Higher body mass index (BMI) predicts more negative self-concept. Body image and physical appearance contribute to general physical self-concept and self-esteem.
Regardless of race, gender, age, and socioeconomic status individuals are discriminated against on the basis of weight. Weight-based stigmatization influences self-perception and the perceptions of significant others. Sustained low self-esteem may precipitate anxiety, depression, under achievement, poor motivation and inadequate interpersonal relations.
Obese adolescents are stigmatized by peers. They may attempt to protect their self-image by participating in high-risk behaviors. Obese adolescent girls are more likely to report adverse social, educational and psychological correlates than obese boys. Overweight girls, but not overweight boys, manifest more depressive symptoms than their normal-weight peers. Gender differences in clinical depressive syndromes may emerge in early childhood as opposed to puberty as previously thought.
Early stigmatization of obese children may explain their lower self-esteem and greater shame, humiliation, and perceived teasing compared with their nonobese peers. Studies have found increased psychopathology among clinical samples of obese children and demonstrated improvements in psychological functioning with weight loss. Implementing lifestyle changes during early adolescence, ages 10 to 13 years, and middle adolescence, ages 14 to 16 years, may hold the key for preventing obesity and depression.
The study population will consist of approximately 100 overweight or at-risk for overweight female volunteers, 10 - 14 years old.
Study design
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Girls 10 through 14 years of age who are in good general health and have a BMI in the 85th to 95th percentile or greater than the 95th percentile
- Availability of a parent or guardian to ensure the child attends all monthly clinic visits and who will be available to attend the monthly educational sessions if the child is assigned to the intervention group
Key exclusion criteria (3 listed)
- Cardiac or pulmonary conditions such as cystic fibrosis, congenital heart disease, or other conditions that would impair ability to do fitness testing
- Physical challenges such as deformities that would impair ability to perform physical activities
- Use of medications such as corticosteroids, seizure medication, or other central nervous system (CNS) medications that would interfere with daily physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary and physical activity modifications | Behavioural | – |
Primary outcome
Decreased body mass index; increased physical activity
1 secondary outcome
Improved self-esteem; improved depression scale score; decreased risk-taking behavior
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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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.
Joan R Griffith, MD principal investigator
University of Kentucky
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 Obesity and Depression, run by University of Kentucky 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 Nov 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Decreased body mass index; increased physical activity. 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 8 Nov 2016.