Barriers to Treatment in Obese Adolescents - Full Text View

Purpose

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

Condition	Intervention	Phase
Obesity	Behavioral: Motivational Interviewing Behavioral: Strength and Cardiovascular Conditioning Behavioral: Food selection and portion control	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Exercise and Physical Fitness Obesity

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

A decrease in body mass index. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Improvement in metabolic indicators. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Improvement in fitness measures [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improved subject compliance with exercise and diet. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Improved parental compliance and support. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Increase knowledge of nutritional principles [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Improved attitude toward healthy behaviors [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Increased self-esteem and motivation [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Decreased negativity [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
Improved family cohesiveness [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	November 2003
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lifestyle Intervention Dietary modification and exercise.	Behavioral: 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. 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. 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.

Arms

Assigned Interventions

Experimental: Lifestyle Intervention

Dietary modification and exercise.

Behavioral: 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.

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.

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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	11 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167830

Locations

United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

VA Premier Health

Investigators

Principal Investigator:

Edmond Wickham, M.D.

Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics

More Information

Publications:

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. 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

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.

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.

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. Epub 2011 Jan 10.

Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00167830 History of Changes
Other Study ID Numbers:	760
Study First Received:	September 9, 2005
Last Updated:	December 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:

Pediatric Overweight,
African American;
Adolescent;
Intervention,
Teasing;
Self-esteem
Quality of Life
Metabolic syndrome
Insulin resistance

Diabetes
Nutrition
Motivation
Culture
BMI
Cardiorespiratory fitness
Resistance Training
Compliance

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013