Mood and Behavior Changes Among Overweight Adolescent Females
|First Received Date ICMJE||August 4, 2005|
|Last Updated Date||January 8, 2008|
|Start Date ICMJE||January 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Decreased body mass index; increased physical activity|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00127374 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Improved self-esteem; improved depression scale score; decreased risk-taking behavior|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Mood and Behavior Changes Among Overweight Adolescent Females|
|Official Title ICMJE||Mood and Behavior Changes Among Overweight Adolescent Females|
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:
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 Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
|Intervention ICMJE||Behavioral: Dietary and physical activity modifications|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Estimated Completion Date||July 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||10 Years to 14 Years (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00127374|
|Other Study ID Numbers ICMJE||04-0541-F3R|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Kentucky|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Kentucky|
|Verification Date||August 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP