Barriers to Effective Weight Loss in Overweight Adolescents

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Behavioral: Lifestyle modification

• Registration Number: NCT00562263
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-28
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 257

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Modification	Lifestyle modification	Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.

Primary Outcome Measures

Name	Time	Method
changes in BMI Z-score	3 month, 6 month, 12 months and 24 months

Secondary Outcome Measures

Name	Time	Method
Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores.	3 month, 6 month, 1 year and 2 years.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States