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

Pediatric Obesity Clinical Trial

Official title:

Pediatric Quality of Life Among Population With BMI Greater Than or Equal to 85%: Impact of a Behavioral Intervention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714870
• Other study ID #: 00446
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: May 29, 2013
• Start date: February 2008
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 20 Years

Eligibility

Inclusion Criteria:

• Ages 10-20

• BMI greater or equal to 85%

Study Design

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

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Steward St. Elizabeth's Medical Center	Brighton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later	No