Clinical trial NCT00167830: Barriers to Treatment in Obese Adolescents
Official title: Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Keywords: 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
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: VA Premier Health
First posted: 2005-09-14
Enrollment: 292
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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

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 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

Primary outcomes:
measure: A decrease in body mass index.
timeFrame: 6 months and 1 year
measure: Improvement in metabolic indicators.
timeFrame: 6 months and 1 year
measure: Improvement in fitness measures
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: Improved subject compliance with exercise and diet.
timeFrame: 6 months and 1 year
measure: Improved parental compliance and support.
timeFrame: 6 months and 1 year
measure: Increase knowledge of nutritional principles
timeFrame: 6 months and 1 year
measure: Improved attitude toward healthy behaviors
timeFrame: 6 months and 1 year
measure: Increased self-esteem and motivation
timeFrame: 6 months and 1 year
measure: Decreased negativity
timeFrame: 6 months and 1 year
measure: Improved family cohesiveness
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics
name: Edmond Wickham, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.