Barriers to Effective Weight Loss in Overweight Adolescents

Overweight Clinical Trial

— TEENS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562263
• Other study ID #: HM11113
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: March 28, 2014
• Start date: October 2007
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• Lifestyle modification
Dietary modification and regular physical activity

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in BMI Z-score		3 month, 6 month, 12 months and 24 months	No
Secondary	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.	No