Barriers to Effective Weight Loss in Overweight Adolescents (TEENS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00562263
First received: November 20, 2007
Last updated: March 28, 2014
Last verified: March 2014

November 20, 2007
March 28, 2014
October 2007
November 2013   (final data collection date for primary outcome measure)
changes in BMI Z-score [ Time Frame: 3 month, 6 month, 12 months and 24 months ] [ Designated as safety issue: No ]
changes in BMI Z-score [ Time Frame: 3 month, 6 month, 12 months and 24 months ]
Complete list of historical versions of study NCT00562263 on ClinicalTrials.gov Archive Site
Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores. [ Time Frame: 3 month, 6 month, 1 year and 2 years. ] [ Designated as safety issue: No ]
Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores. [ Time Frame: 3 month, 6 month, 1 year and 2 years. ]
Not Provided
Not Provided
 
Barriers to Effective Weight Loss in Overweight Adolescents
Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program

The current study aims to investigate the impact of a comprehensive, team-based, family-centered, lifestyle modification program on body weight, metabolic abnormalities, fitness measures, and self-esteem in overweight adolescents beginning the study at ages 11-18 years. The intensive program will uniquely include a "team" structure and a component designed to address the role of parental modeling in effective lifestyle changes. By comparing the demographic, psychosocial, and metabolic characteristics of adolescents according to the degree of weight loss, the study will also more fully characterize the barriers that prevent successful participation in an intensive lifestyle modification program.

The study will annually enroll 100 - 200 adolescent male and female subjects between 11 and 18 years of age with a BMI > the 85th percentile and one parent. Adolescents enrolled in the study, will participate in a structured exercise program and meet regularly with a dietitian and behavior specialist for nutrition education and review and update of progress and goals. The study is designed for 2 years of participation with data collection points at baseline, 3 months, 6 months, 1 year and 2 years. Data collected from adolescents include demographic information anthropometric information (height, weight, blood pressure, temperature, pulse, percent body fat); assessments of nutritional knowledge, food choices and dietary intake; assessments of activity and fitness level of behavioral status (depression, self-esteem, self-confidence, satisfaction with life, happiness, perspectives on health, exercise and diet, family environment, quality of life, body awareness, teasing, social efficacy, self-perception, coping mechanisms), assessments of sleep time and quality and physiological and medical data (including blood and urine tests)

Parents will accompany their children to the nutrition and behavior support visits, and attend 12 group educational sessions to learn skills and strategies to help their children adopt healthier eating and exercise behaviors. Data collected from parents will include demographic, anthropometric measures (height, weight, blood pressure, temperature, pulse, percent body fat); and assessments of activity level, dietary intake and eating habits, behavioral status, child-feeding practices, and understanding of their child.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Overweight
Behavioral: Lifestyle modification
Dietary modification and regular physical activity
Other Names:
  • Weight Loss
  • Wellness
  • Experimental: Lifestyle Modification
    Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.
    Intervention: Behavioral: Lifestyle modification
  • No Intervention: Control
    Teen participates in lifestyle intervention, but parent does not attend parent education sessions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
257
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 11 and 18
  • BMI at or above the 85th percentile for age and sex
  • At least one adult in the household who is committed to come to the program meetings

Exclusion Criteria:

  • Previous enrollment in VCU IRB 3354
  • Underlying genetic, neurologic, endocrine, or metabolic conditions that preclude weight loss with conventional diet and exercise programs
  • Weight greater than 400 pounds
  • Pregnancy in female adolescent subjects
  • Inability to understand program instructions due to language barrier or a mental disability
  • Primary residence outside a 30 mile radius program facility.
  • Primary participating parent, if female, cannot be pregnant during the period corresponding to the parents intervention.
Female
11 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00562263
HM11113
Yes
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Gary L. Francis, M.D. Virginia Commonwealth University
Virginia Commonwealth University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP