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Barriers to Effective Weight Loss in Overweight Adolescents (TEENS)

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle modification
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, adolescent, insulin resistance, treatment

Eligibility Criteria

11 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle Modification

Control

Arm Description

Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.

Teen participates in lifestyle intervention, but parent does not attend parent education sessions

Outcomes

Primary Outcome Measures

changes in BMI Z-score

Secondary Outcome Measures

Changes in body composition, metabolic and anthropometric measures, fitness measures, dietary intake, and quality of life scores.

Full Information

First Posted
November 20, 2007
Last Updated
March 28, 2014
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT00562263
Brief Title
Barriers to Effective Weight Loss in Overweight Adolescents
Acronym
TEENS
Official Title
Barriers to Effective Weight Loss in Overweight Adolescents Enrolled in an Intensive, Team-based, Family-centered Lifestyle Modification Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
overweight, obesity, adolescent, insulin resistance, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Modification
Arm Type
Experimental
Arm Description
Parents are randomized to attend 12 educational sessions covering strategies to manage children's health behaviors.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Teen participates in lifestyle intervention, but parent does not attend parent education sessions
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Other Intervention Name(s)
Weight Loss, Wellness
Intervention Description
Dietary modification and regular physical activity
Primary Outcome Measure Information:
Title
changes in BMI Z-score
Time Frame
3 month, 6 month, 12 months and 24 months
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary L. Francis, M.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24212451
Citation
Ning Y, Yang S, Evans RK, Stern M, Sun S, Francis GL, Wickham EP 3rd. Changes in body anthropometry and composition in obese adolescents in a lifestyle intervention program. Eur J Nutr. 2014 Jun;53(4):1093-102. doi: 10.1007/s00394-013-0612-9. Epub 2013 Nov 10.
Results Reference
derived

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Barriers to Effective Weight Loss in Overweight Adolescents

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