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

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

Status: Completed

Conditions: Pediatric Obesity

Treatments: Behavioral: Behavioral nutrition and exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT00714870

00446

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 10 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Ages 10-20
• BMI greater or equal to 85%

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 1 patient group

1

Other group

Description:

intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program

Treatment:

Behavioral: Behavioral nutrition and exercise program