Expired Study
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Lexington, Kentucky 40536


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.

Study summary:

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.


Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Mood and Behavior Changes Among Overweight Adolescent Females

Official Title:

Mood and Behavior Changes Among Overweight Adolescent Females

Overall Status:


Study Phase:




Minimum Age:

10 Years

Maximum Age:

14 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kentucky

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

withdrawn due to non-response. PI left unive

Study Type:


Study Design:


Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Joan R Griffith, MD
Principal Investigator
University of Kentucky

Study Dates

Start Date:January 2005
Completion Date:September 2006
Completion Type:Actual
Primary Completion Date:September 2006
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 7, 2016
First Received Date:August 4, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Improved self-esteem; improved depression scale score; decreased risk-taking behavior
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Decreased body mass index; increased physical activity
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Dietary and physical activity modifications

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kentucky

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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