Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%
Primary Purpose
Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral nutrition and exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring BMI, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Ages 10-20
- BMI greater or equal to 85%
Sites / Locations
- Steward St. Elizabeth's Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
Outcomes
Primary Outcome Measures
Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)
Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).
Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.
Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30.
Secondary Outcome Measures
Full Information
NCT ID
NCT00714870
First Posted
July 9, 2008
Last Updated
May 29, 2013
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00714870
Brief Title
Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%
Official Title
Pediatric Quality of Life Among Population With BMI Greater Than or Equal to 85%: Impact of a Behavioral Intervention Program
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We are currently experiencing an epidemic of obesity in the Pediatric Population. This epidemic affects many areas including quality of life.
We have been conducting a nutrition and exercise program since 2003. We have noticed that many of the participants seem to have a better quality of life after finishing the one year program compared to when they started. We would like to objectively quantify this improvement using a validated questionnaire at the beginning and at the end of the study. Questionnaires will be given to participants and to their caretakers at the same time. There will be two groups in the study: one intervention (minimum attendance of 4 sessions) and one control group.
Detailed Description
We are currently experiencing an obesity epidemic in the Pediatric population. The latest National Health and Nutrition Examination Survey (NHANES) data indicates that 16.5% has a BMI greater than or equal to 85% < 95% and 17.1% has a BMI greater than or equal to 95%. The quality of life of children who are obese has been shown to be lower than that of children with cancer. Health related quality of life measurements have emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. We have conducted a behavioral nutrition and exercise program since 2003. The name of the program is Teens, Empowerment, Exercise, Education, Nutrition (TEEEN) Program. We meet once a month on a Saturday afternoon for four hours. During this time we cover: registration (monitoring of sedentary activities and liquid choices; motivational interview, exercise testing); exercise; educational interactive lectures; didactic games and projects. We have noticed that participants seem to have a better quality of life after participating in the program compared to baseline. We would like to objectively quantify this subjective finding. We will be using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL(TM)4.0) questionnaire which has been validated in the pediatric population. We will have an intervention and a control group. Both participants and their caretakers will be given a questionnaire at the beginning and at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
BMI, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
Intervention Type
Behavioral
Intervention Name(s)
Behavioral nutrition and exercise program
Intervention Description
The intervention consists of a behavioral nutrition and exercise program. Meetings occur monthly on a Saturday afternoon and last 4 hours. During this time we cover: 1)registration: monitoring of sedentary activities and liquid choices, motivational interviewing, exercise testing;2)exercise: includes strength training; 3) educational lectures; 4) didactic games and projects.
Primary Outcome Measure Information:
Title
Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)
Description
Using a validated quality of life questionnaire we analyzed change in child self-report scores comparing baseline questionnaire scores to end of study questionnaire scores for these categories: total (includes physical and psychosocial), physical, and psychosocial(includes emotional, social, and school).
Scale information: The range is 0-100 in terms of points they could get for each category. They had the options of 0-4, 0 being the best. 0 would then be transformed to a score of 100, 1 to 75, 2 to 50, 3 to 25 and 4 to 0.
Results are clinically significant if the difference in scores are higher than the Minimal Clinical Important Difference (MCID). MCID are as follows: Total Score: 4.36, Physical Health: 6.66, Psychosocial Health: 5.30.
Time Frame
one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 10-20
BMI greater or equal to 85%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Gonzalez, MD
Organizational Affiliation
Steward St. Elizabeth's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steward St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135-3514
Country
United States
12. IPD Sharing Statement
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Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%
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