NCT00167830

Brief Summary

The purpose of this study is to identify significant racial and ethnical differences in risk factors for development of obesity and weight loss in adolescents in Central Virginia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
292

participants targeted

Target at P75+ for phase_1 obesity

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

10.1 years

First QC Date

September 9, 2005

Last Update Submit

January 16, 2014

Conditions

Keywords

Pediatric Overweight,African American;Adolescent;Intervention,Teasing;Self-esteemQuality of LifeMetabolic syndromeInsulin resistanceDiabetesNutritionMotivationCultureBMICardiorespiratory fitnessResistance TrainingCompliance

Outcome Measures

Primary Outcomes (3)

  • A decrease in body mass index.

    6 months and 1 year

  • Improvement in metabolic indicators.

    6 months and 1 year

  • Improvement in fitness measures

    6 months and 1 year

Secondary Outcomes (7)

  • Improved subject compliance with exercise and diet.

    6 months and 1 year

  • Improved parental compliance and support.

    6 months and 1 year

  • Increase knowledge of nutritional principles

    6 months and 1 year

  • Improved attitude toward healthy behaviors

    6 months and 1 year

  • Increased self-esteem and motivation

    6 months and 1 year

  • +2 more secondary outcomes

Study Arms (1)

Lifestyle Intervention

EXPERIMENTAL

Dietary modification and exercise.

Behavioral: Motivational InterviewingBehavioral: Strength and Cardiovascular ConditioningBehavioral: Food selection and portion control

Interventions

Biweekly meetings with a behavior specialist to review subject's progress with the protocol and explore challenges subject is facing in adopting healthy lifestyle behaviors.

Lifestyle Intervention

Subjects take part in an exercise program to include 30 minutes of cardiorespiratory exercise at 70% maximum heart rate, and 30 minutes of strength training on Nautilus machines.

Lifestyle Intervention

Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.

Lifestyle Intervention

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 11-18
  • Above 95th percentile for weight
  • Reside within 30 miles of program site
  • Ability to comprehend basic instructions
  • Ability to perform basic exercise movements

You may not qualify if:

  • Having a metabolic disorder that causes weight gain
  • Having a cognitive deficit that impacts learning and comprehension
  • Having a physical defect that prevents exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (7)

  • Wickham EP, Stern M, Evans RK, Bryan DL, Moskowitz WB, Clore JN, Laver JH. Prevalence of the metabolic syndrome among obese adolescents enrolled in a multidisciplinary weight management program: clinical correlates and response to treatment. Metab Syndr Relat Disord. 2009 Jun;7(3):179-86. doi: 10.1089/met.2008.0038.

    PMID: 19450141BACKGROUND
  • Porter JS, Bean MK, Gerke CK, Stern M. Psychosocial factors and perspectives on weight gain and barriers to weight loss among adolescents enrolled in obesity treatment. J Clin Psychol Med Settings. 2010 Jun;17(2):98-102. doi: 10.1007/s10880-010-9186-3.

    PMID: 20119710BACKGROUND
  • Bean MK, Mazzeo SE, Stern M, Evans RK, Bryan D, Ning Y, Wickham EP 3rd, Laver J. Six-month dietary changes in ethnically diverse, obese adolescents participating in a multidisciplinary weight management program. Clin Pediatr (Phila). 2011 May;50(5):408-16. doi: 10.1177/0009922810393497. Epub 2011 Jan 10.

    PMID: 21224253BACKGROUND
  • Stern M, Mazzeo SE, Gerke CK, Porter JS, Bean MK, Laver JH. Gender, ethnicity, psychosocial factors, and quality of life among severely overweight, treatment-seeking adolescents. J Pediatr Psychol. 2007 Jan-Feb;32(1):90-4. doi: 10.1093/jpepsy/jsl013. Epub 2006 Jul 3.

  • Stern M, Mazzeo SE, Porter J, Gerke C, Bryan D,and Laver J. Self-esteem, teasing and quality of life: African American adolescent girls participating in a family-based pediatric overweight intervention. Journal of Clinical Psychology in Medical Settings. DOI:10.1007/s10880-006-9029-4, 2006

    RESULT
  • Browning MG, Bean MK, Wickham EP, Stern M, Evans RK. Cardiometabolic and Fitness Improvements in Obese Girls Who Either Gained or Lost Weight during Treatment. J Pediatr. 2015 Jun;166(6):1364-9. doi: 10.1016/j.jpeds.2015.03.011. Epub 2015 Apr 15.

  • Ning Y, Yang S, Evans RK, Stern M, Sun S, Francis GL, Wickham EP 3rd. Changes in body anthropometry and composition in obese adolescents in a lifestyle intervention program. Eur J Nutr. 2014 Jun;53(4):1093-102. doi: 10.1007/s00394-013-0612-9. Epub 2013 Nov 10.

MeSH Terms

Conditions

ObesityMetabolic SyndromeInsulin ResistanceDiabetes MellitusPatient Compliance

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Edmond Wickham, M.D.

    Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

November 1, 2003

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations