Barriers to Treatment in Obese Adolescents

Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Strength and Cardiovascular Conditioning; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Decreased negativity	6 months and 1 year
Improved family cohesiveness	6 months and 1 year

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: VA Premier Health
• Investigators: Principal Investigator: Edmond Wickham, M.D., Virginia Commonwealth University Depts. of Internal Medicine and Pediatrics

Publications and helpful links

General Publications

• 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.
• 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.
• 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. doi: 10.1177/0009922810393497. Epub 2011 Jan 10.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Estimate): January 20, 2014
• Last Update Submitted That Met QC Criteria: January 16, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes; Metabolic syndrome; Insulin resistance; Quality of Life; Motivation; Nutrition; Compliance; Resistance Training; BMI; Cardiorespiratory fitness; Culture; Self-esteem; African American;; Intervention,; Pediatric Overweight,; Adolescent;; Teasing
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 760