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Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%

This study is currently recruiting participants.
Verified February 2012 by Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor:
Information provided by (Responsible Party):
Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier:
NCT00714870
First received: July 9, 2008
Last updated: February 2, 2012
Last verified: February 2012
History of Changes

July 9, 2008
February 2, 2012
February 2008
August 2012   (final data collection date for primary outcome measure)
  • baseline quality of life scores and comparison to referent population [ Time Frame: one year ] [ Designated as safety issue: No ]
  • change in quality of life scores after intervention [ Time Frame: one year ] [ Designated as safety issue: No ]
  • comparison of scores between intervention and control groups [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00714870 on ClinicalTrials.gov Archive Site
  • use of caretakers' proxy data to examine above questions [ Time Frame: one year ] [ Designated as safety issue: No ]
  • explore role of demographics/socioeconomic factors [ Time Frame: one year ] [ Designated as safety issue: No ]
  • explore influence of intervention on physical and psychosocial sub-scores [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%
Pediatric Quality of Life Among Population With BMI Greater Than or Equal to 85%: Impact of a Behavioral Intervention Program

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.

We are currently experiencing an obesity epidemic in the Pediatric population. The latest 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 the TEEEN (teens, empowerment, exercise, education, nutrition). 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 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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pediatric Obesity
Behavioral: Behavioral nutrition and exercise program
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.
1
intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
Intervention: Behavioral: Behavioral nutrition and exercise program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 10-20
  • BMI greater or equal to 85%
Both
10 Years to 20 Years
Yes
Not Provided
United States
 
NCT00714870
00446
Yes
Steward St. Elizabeth's Medical Center of Boston, Inc.
Steward St. Elizabeth's Medical Center of Boston, Inc.
Not Provided
Principal Investigator: Shirley Gonzalez, MD Steward St. Elizabeth's Medical Center
Steward St. Elizabeth's Medical Center of Boston, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP