Trial Outcomes & Findings for Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85% (NCT NCT00714870)
NCT ID: NCT00714870
Last Updated: 2013-05-31
Results Overview
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.
COMPLETED
NA
76 participants
one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later
2013-05-31
Participant Flow
Participants with BMI % greater than or equal to 85% ages 9-20 were recruited from providers' offices between 2008-2012
Participants with endocrinologic conditions associated with weight gain were excluded from enrollment
Participant milestones
| Measure |
Intervention: Nutrition and Exercise Program
intervention: this group will 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.
|
Control Group: Standard of Care at Pediatrician's Office
control group: this group will not attend the nutrition and exercise program
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
27
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
27
|
5
|
Reasons for withdrawal
| Measure |
Intervention: Nutrition and Exercise Program
intervention: this group will 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.
|
Control Group: Standard of Care at Pediatrician's Office
control group: this group will not attend the nutrition and exercise program
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
5
|
|
Overall Study
patient unable to come b/c back pain
|
1
|
0
|
|
Overall Study
did not attend minimum of 4 sessions
|
4
|
0
|
Baseline Characteristics
Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%
Baseline characteristics by cohort
| Measure |
Intervention: Nutrition and Exercise Program
n=22 Participants
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.
|
Control Group
n=22 Participants
control group: this group will not attend the nutrition and exercise program
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age Continuous
|
11.6 years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
12 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
11.8 years
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
44 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year laterPopulation: 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
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.
Outcome measures
| Measure |
Intervention: Nutrition and Exercise Program
n=22 Participants
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.
|
Control
n=22 Participants
Control group received the standard of care at pediatrician's office
|
|---|---|---|
|
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
|
-0.9 units on a scale
Standard Deviation 15.6
|
|
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
|
-0.3 units on a scale
Standard Deviation 14.2
|
|
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
|
-1.2 units on a scale
Standard Deviation 17.6
|
Adverse Events
Intervention: Nutrition and Exercise Program
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place