Pediatric ObesityNCT00714870
Pediatric Quality of Life Among Population With Body Mass Index (BMI) Greater Than or Equal to 85%
A study testing Behavioral nutrition and exercise program in people with Pediatric Obesity, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Behavioral nutrition and exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 10-20
- BMI greater or equal to 85%
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135-3514
About this study
Official title: Pediatric Quality of Life Among Population With BMI Greater Than or Equal to 85%: Impact of a Behavioral Intervention Program
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- Behavioral nutrition and exercise program
- Keywords
- BMI, Quality of life
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral nutrition and exercise programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | intervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program Receives: Behavioral: Behavioral nutrition and exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirley Gonzalez, MD, Principal investigator, Steward St. Elizabeth's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714870
- Sponsor's protocol ID
- 00446
- Status last verified
- May 2013
- First submitted
- 9 Jul 2008
- Last updated
- 31 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Quality of Life Among Population With BMI Greater Than or Equal to 85%: Impact of a Behavioral Intervention Program
- ClinicalTrials.gov ID
- NCT00714870
- Acronym / sponsor ID
- 00446
- Conditions
- Pediatric Obesity
- Keywords
- BMI, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Posted 31 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Behavioral nutrition and exercise programintervention: this group will attend the nutrition and exercise program control group: this group will not attend the nutrition and exercise program |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 10-20
- BMI greater or equal to 85%
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral nutrition and exercise programThe 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. | Behavioural | 1 |
Primary outcome
Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley Gonzalez, MD principal investigator
Steward St. Elizabeth's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral nutrition and exercise program in people with Pediatric Obesity, run by Steward St. Elizabeth's Medical Center of Boston, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Self-report Health Related Quality of Life Scores After Intervention: Total, Physical and Psychosocial (Presented in This Order) (time frame: one year comparing change in questionnaire scores at baseline to results from questionnaire completed a year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.