Barriers to Effective Weight Loss in Overweight Adolescents (TEENS)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 20, 2007 | ||||
| Last Updated Date | August 17, 2012 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
changes in BMI Z-score [ Time Frame: 3 month, 6 month, 12 months and 24 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
changes in BMI Z-score [ Time Frame: 3 month, 6 month, 12 months and 24 months ] | ||||
| Change History | Complete list of historical versions of study NCT00562263 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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. ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Barriers to Effective Weight Loss in Overweight Adolescents | ||||
| Official Title ICMJE | Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program | ||||
| 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 Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Overweight | ||||
| Intervention ICMJE | Behavioral: Lifestyle modification
Dietary modification and regular physical activity
Other Names:
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | November 2013 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 11 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00562263 | ||||
| Other Study ID Numbers ICMJE | HM11113 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Virginia Commonwealth University | ||||
| Study Sponsor ICMJE | Virginia Commonwealth University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Virginia Commonwealth University | ||||
| Verification Date | August 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||