Pediatric Obesity
Conditions
Keywords
BMI, Quality of life
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.
Interventions
BEHAVIORALBehavioral 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.
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 10-20 * BMI greater or equal to 85%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) | one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later | 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. |
Countries
United States
Participant flow
Recruitment details
Participants with BMI % greater than or equal to 85% ages 9-20 were recruited from providers' offices between 2008-2012
Pre-assignment details
Participants with endocrinologic conditions associated with weight gain were excluded from enrollment
Participants by arm
| Arm | Count |
|---|---|
| Intervention: Nutrition and Exercise Program intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program
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. | 22 |
| Control Group control group: this group will not attend the nutrition and exercise program | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not attend minimum of 4 sessions | 4 | 0 |
| Overall Study | Lost to Follow-up | 22 | 5 |
| Overall Study | patient unable to come b/c back pain | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Intervention: Nutrition and Exercise Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 21 Participants | 43 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age Continuous | 12 years STANDARD_DEVIATION 2.3 | 11.6 years STANDARD_DEVIATION 2.1 | 11.8 years STANDARD_DEVIATION 2.2 |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later
Population: To detect an effect with greater than or equal to 80% power at a 0.05 two sided significant level, we concluded we needed 22 participants completing each group, intervention and control
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention: Nutrition and Exercise Program | Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) | Mean change in scores: Total | 7.8 units on a scale | Standard Deviation 16.8 |
| Intervention: Nutrition and Exercise Program | Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) | Mean change in scores: Physical | 9.1 units on a scale | Standard Deviation 22.5 |
| Intervention: Nutrition and Exercise Program | Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) | Mean change in scores: Psychosocial | 7.2 units on a scale | Standard Deviation 17.7 |
| Control | Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) | Mean change in scores: Total | -0.9 units on a scale | Standard Deviation 15.6 |
| Control | Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) | Mean change in scores: Physical | -0.3 units on a scale | Standard Deviation 14.2 |
| Control | Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) | Mean change in scores: Psychosocial | -1.2 units on a scale | Standard Deviation 17.6 |