Overweight Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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