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
  Purpose

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.


Condition Intervention
Overweight
Behavioral: Lifestyle modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • changes in BMI Z-score [ Time Frame: 3 month, 6 month, 12 months and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 257
Study Start Date: October 2007
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Modification
Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.
Behavioral: Lifestyle modification
Dietary modification and regular physical activity
Other Names:
  • Weight Loss
  • Wellness
No Intervention: Control
Teen participates in lifestyle intervention, but parent does not attend parent education sessions

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562263

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Gary L. Francis, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00562263     History of Changes
Other Study ID Numbers: HM11113
Study First Received: November 20, 2007
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
overweight
obesity
adolescent
insulin resistance
treatment

Additional relevant MeSH terms:
Weight Loss
Overweight
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014