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

NCT00714870 | Completed Results DMC

• 1 other identifier: 00446
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

BMI; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

OTHER

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

Behavioral: Behavioral nutrition and exercise program

Interventions

Behavioral nutrition and exercise program BEHAVIORAL

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

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135-3514, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Shirley Gonzalez
• Organization: St. Elizabeth's Medical Center

shirleyg2008@gmail.com

617-926-0114

Study Officials

• Shirley Gonzalez, MD

  Steward St. Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 14, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-05

Locations

US (1)