Barriers to Treatment in Obese Adolescents

NCT ID: NCT00167830

Last Updated: 2014-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2013-12-31

Brief Summary

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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

Detailed Description

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* Participation for 6 months in a program incorporating exercise, nutritional counseling and behavioral support leads to measurable improvements in overall fitness, metabolic indicators and loss of body fat for obese adolescents.
* Degree of loss of body fat, improved overall fitness and improvements in metabolic indicators can be correlated with the degree of compliance and participation for 6 months in the program.
* Parental involvement and support can be correlated with the degree of compliance and participation in the program.
* Socioeconomic factors can be correlated with the degree of compliance and participation in the program.
* Cultural differences in diet, attitudes toward body shape, and family dynamics can be correlated with success or failure in a weight loss program.
* Individual differences in self-esteem, self-discipline and feelings of connectedness with family members can be correlated with success or failure in a weight loss program.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Lifestyle Intervention

Dietary modification and exercise.

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

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.

Strength and Cardiovascular Conditioning

Intervention Type BEHAVIORAL

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.

Food selection and portion control

Intervention Type BEHAVIORAL

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

Interventions

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Motivational Interviewing

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.

Intervention Type BEHAVIORAL

Strength and Cardiovascular Conditioning

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.

Intervention Type BEHAVIORAL

Food selection and portion control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Having a metabolic disorder that causes weight gain
* Having a cognitive deficit that impacts learning and comprehension
* Having a physical defect that prevents exercise
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Premier Health

UNKNOWN

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edmond Wickham, M.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 19450141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20119710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21224253 (View on PubMed)

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.

Reference Type RESULT
PMID: 16818482 (View on PubMed)

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

Reference Type 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.

Reference Type DERIVED
PMID: 25890676 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24212451 (View on PubMed)

Other Identifiers

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760

Identifier Type: -

Identifier Source: org_study_id

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