NCT00127374

Brief 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 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

August 4, 2005

Last Update Submit

November 7, 2016

Conditions

Keywords

Overweight; self-esteem; depression

Outcome Measures

Primary Outcomes (1)

  • Decreased body mass index; increased physical activity

Secondary Outcomes (1)

  • Improved self-esteem; improved depression scale score; decreased risk-taking behavior

Interventions

Eligibility Criteria

Age10 Years - 14 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

ObesityDepressionOverweight

Interventions

Diet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Joan R Griffith, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 5, 2005

Study Start

January 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations