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Completed

NCT Number: NCT00562263

Barriers to Effective Weight Loss in Overweight Adolescents

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.

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Key information

Age range

11 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Modification

Behavioral

Dietary modification and regular physical activity

Other names: Weight Loss, Wellness

Primary outcomes

  1. changes in BMI Z-score

    Time frame: 3 month, 6 month, 12 months and 24 months

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program

Acronym: TEENS

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2007
Registry last updated
Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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