ObesityNCT00160914
Childhood Obesity: Variations in Management
An observational study of Obesity, run by University of Chicago at 1 site in United States.
Trial summary
Childhood obesity has been described as a growing national epidemic. Between 1980 and 1994 the prevalence of childhood obesity doubled with 10% to 15% of children and adolescents being obese. Childhood obesity has both immediate and long-term detrimental consequences for health and well-being. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Identification/management of childhood obesity (behavior)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Practicing general pediatricians
Who may be able to join
- Practicing general pediatricians
Who cannot join
- Non practicing general pediatricians
Trial locations and contacts
1 site in 1 country.
About this study
Childhood obesity has been described as a growing national epidemic. Between 1980 and 1994 the prevalence of childhood obesity doubled with 10% to 15% of children and adolescents being obese. Childhood obesity has both immediate and long-term detrimental consequences for health and well-being. Obese children are at increased risk for coronary heart disease, type 2 diabetes, and hypertension. Obese children are more likely to be at risk for psychological stress and disturbed body image. Moreover, obese children are more likely to become obese adults, especially if weight reduction has not occurred by the end of adolescence.
The pediatrician is in an ideal position to assess and manage childhood obesity. Recently, guidelines have been established for the assessment and treatment of childhood obesity. These "best practice" guidelines include recommended diagnostic criteria, assessment of contributing factors such as diet and lifestyle, family history, and treatment choices. Although these guidelines have been introduced little is known about pediatricians' actual practice patterns and their beliefs concerning childhood obesity.
Project Description I plan to conduct a national survey of pediatricians to assess common strategies for the identification and management of childhood obesity, along with pediatricians' attitudes and beliefs about childhood obesity. In consultation with a panel of practicing general pediatricians and survey research experts, I plan to develop a survey that measures pediatricians' beliefs about the causes and consequences of childhood obesity, its prevalence in their practice settings, their approaches to diagnosis and management, and resources available for treatment. The survey will be administered to a randomly selected national sample of approximately 600 practicing general pediatricians. The response rate is expected to be approximately 60% or 360 pediatricians. The survey results will help to assess the degree to which recommended practice guidelines are being implemented, identify pediatricians' beliefs and attitudes that might serve as barriers to optimal care, and suggest areas for continuing medical education. The proposed time frame for the study is two years.
Read the detailed description
Project Goals
Year One
- Develop and Pilot Test Survey. The Pediatrician Survey will be designed to assess both practice patterns and attitudes/beliefs pertaining to childhood and adolescent obesity. From a review of the literature and the recently published guidelines, along with interviews with practicing pediatricians, we will generate items that assess relevant diagnostic and therapeutic approaches to childhood obesity, including patient and physician demographic data. We will also thoroughly review the literature to identify attitudes and beliefs that may impact pediatricians approaches to obesity management. The survey will be pilot tested with a small sample of practicing pediatricians, and appropriate modifications in the survey will be made.
- Select Sample. We will use the American Academy of Pediatrics Fellowship Directory to identify a national pool of practicing pediatricians. To allow us to assess any regional differences in practice patterns, we will stratify the pool of practicing pediatricians by geographic region and randomly select 150 pediatricians from within each of four geographic regions. This will allow us to survey a total of 600 practicing pediatricians.
- Mail Surveys. Using addresses provided by the Directory, we will send surveys via mail to selected pediatricians. All mailings will be coded and entered into a computerized master list that will facilitate tracking of surveys received and follow-up. Surveys sent and received will be tracked. Based on prior research experience, we expect an initial response rate of approximately 50%. One month after the initial mailing, we will conduct a second mailing to non--responders, sending a reminder postcard requesting the completion and return of the survey. Two months after the initial mailing, a second letter and survey will be sent to those who still have not responded. With this method, we expect a final response rate of 60%
Year Two
- Data Entry and Analysis. Data from returned surveys, including respondent demographic characteristics, practice structure and setting, practice patterns, and attitudes/beliefs will be entered into a database for subsequent analysis. Data will be double-entered and checked for accuracy. Data analysis will consist of establishing psychometric properties of attitude and belief measures, examining frequencies of responses to, individual items, looking for trends across geographic regions, and assessing common approaches to the diagnosis and management of childhood obesity. Moreover, we will analyze the data to determine the relationship of attitudes/beliefs and practice patterns. We anticipate that we will identify a number of important variations in the diagnosis and management of childhood obesity. We also expect to identify a number of personal and systems-related barriers to treatment of childhood obesity. For example, we expect that pediatricians with more recent training will have more optimistic attitudes toward successful management of childhood obesity. We also expect to find variations in reimbursement and clinic resources, and that these will impact pediatricians' approaches.
- Conditions
- Obesity
- Being tested
- Identification/management of childhood obesity (behavior)
- Keywords
- Childhood obesity
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification/management of childhood obesity (behavior)Behavioural
In this project, we plan to conduct a national survey of pediatricians to assess common strategies for identification and management of childhood obesity, along with pediatricians' attitudes and beliefs about childhood obesity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- The Nathan Cummings Foundation
- Responsible party
- Sponsor
- Investigators
- Janis Mendelsohn, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160914
- Sponsor's protocol ID
- 11408B
- Status last verified
- Apr 2016
- First submitted
- 8 Sep 2005
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: prevalence and trends, 1960-1994. Int J Obes Relat Metab Disord. 1998 Jan;22(1):39-47. doi: 10.1038/sj.ijo.0800541.
PubMed 9481598Lauer RM, Connor WE, Leaverton PE, Reiter MA, Clarke WR. Coronary heart disease risk factors in school children: the Muscatine study. J Pediatr. 1975 May;86(5):697-706. doi: 10.1016/s0022-3476(75)80353-2.
PubMed 1133650Drash A. Relationship between diabetes mellitus and obesity in the child. Metabolism. 1973 Feb;22(2):337-44. doi: 10.1016/0026-0495(73)90185-6. No abstract available.
PubMed 4687958Londe S, Bourgoignie JJ, Robson AM, Goldring D. Hypertension in apparently normal children. J Pediatr. 1971 Apr;78(4):569-77. doi: 10.1016/s0022-3476(71)80457-2. No abstract available.
PubMed 5555589French SA, Story M, Perry CL. Self-esteem and obesity in children and adolescents: a literature review. Obes Res. 1995 Sep;3(5):479-90. doi: 10.1002/j.1550-8528.1995.tb00179.x.
PubMed 8521169Serdula MK, Ivery D, Coates RJ, Freedman DS, Williamson DF, Byers T. Do obese children become obese adults? A review of the literature. Prev Med. 1993 Mar;22(2):167-77. doi: 10.1006/pmed.1993.1014.
PubMed 8483856Barlow SE, Dietz WH. Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services. Pediatrics. 1998 Sep;102(3):E29. doi: 10.1542/peds.102.3.e29.
PubMed 9724677American Academy of Pediatrics. Fellowship Directory. Elk Grove Village, IL: American Academy of Pediatrics., 2001.
Dietz WH, Nelson A. Barriers to the treatment of childhood obesity: a call to action. J Pediatr. 1999 May;134(5):535-6. doi: 10.1016/s0022-3476(99)70235-0. No abstract available.
PubMed 10228284
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Obesity: Variations in Management
- ClinicalTrials.gov ID
- NCT00160914
- Acronym / sponsor ID
- 11408B
- Conditions
- Obesity
- Keywords
- Childhood obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- The Nathan Cummings Foundation
- Study start
- Dec 2001
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood obesity has been described as a growing national epidemic. Between 1980 and 1994 the prevalence of childhood obesity doubled with 10% to 15% of children and adolescents being obese. Childhood obesity has both immediate and long-term detrimental consequences for health and well-being. Obese children are at increased risk for coronary heart disease, type 2 diabetes, and hypertension. Obese children are more likely to be at risk for psychological stress and disturbed body image. Moreover, obese children are more likely to become obese adults, especially if weight reduction has not occurred by the end of adolescence.
The pediatrician is in an ideal position to assess and manage childhood obesity. Recently, guidelines have been established for the assessment and treatment of childhood obesity. These "best practice" guidelines include recommended diagnostic criteria, assessment of contributing factors such as diet and lifestyle, family history, and treatment choices. Although these guidelines have been introduced little is known about pediatricians' actual practice patterns and their beliefs concerning childhood obesity.
Project Description I plan to conduct a national survey of pediatricians to assess common strategies for the identification and management of childhood obesity, along with pediatricians' attitudes and beliefs about childhood obesity. In consultation with a panel of practicing general pediatricians and survey research experts, I plan to develop a survey that measures pediatricians' beliefs about the causes and consequences of childhood obesity, its prevalence in their practice settings, their approaches to diagnosis and management, and resources available for treatment. The survey will be administered to a randomly selected national sample of approximately 600 practicing general pediatricians. The response rate is expected to be approximately 60% or 360 pediatricians. The survey results will help to assess the degree to which recommended practice guidelines are being implemented, identify pediatricians' beliefs and attitudes that might serve as barriers to optimal care, and suggest areas for continuing medical education. The proposed time frame for the study is two years.
Detailed description
Project Goals
Year One
- Develop and Pilot Test Survey. The Pediatrician Survey will be designed to assess both practice patterns and attitudes/beliefs pertaining to childhood and adolescent obesity. From a review of the literature and the recently published guidelines, along with interviews with practicing pediatricians, we will generate items that assess relevant diagnostic and therapeutic approaches to childhood obesity, including patient and physician demographic data. We will also thoroughly review the literature to identify attitudes and beliefs that may impact pediatricians approaches to obesity management. The survey will be pilot tested with a small sample of practicing pediatricians, and appropriate modifications in the survey will be made.
- Select Sample. We will use the American Academy of Pediatrics Fellowship Directory to identify a national pool of practicing pediatricians. To allow us to assess any regional differences in practice patterns, we will stratify the pool of practicing pediatricians by geographic region and randomly select 150 pediatricians from within each of four geographic regions. This will allow us to survey a total of 600 practicing pediatricians.
- Mail Surveys. Using addresses provided by the Directory, we will send surveys via mail to selected pediatricians. All mailings will be coded and entered into a computerized master list that will facilitate tracking of surveys received and follow-up. Surveys sent and received will be tracked. Based on prior research experience, we expect an initial response rate of approximately 50%. One month after the initial mailing, we will conduct a second mailing to non--responders, sending a reminder postcard requesting the completion and return of the survey. Two months after the initial mailing, a second letter and survey will be sent to those who still have not responded. With this method, we expect a final response rate of 60%
Year Two
- Data Entry and Analysis. Data from returned surveys, including respondent demographic characteristics, practice structure and setting, practice patterns, and attitudes/beliefs will be entered into a database for subsequent analysis. Data will be double-entered and checked for accuracy. Data analysis will consist of establishing psychometric properties of attitude and belief measures, examining frequencies of responses to, individual items, looking for trends across geographic regions, and assessing common approaches to the diagnosis and management of childhood obesity. Moreover, we will analyze the data to determine the relationship of attitudes/beliefs and practice patterns. We anticipate that we will identify a number of important variations in the diagnosis and management of childhood obesity. We also expect to identify a number of personal and systems-related barriers to treatment of childhood obesity. For example, we expect that pediatricians with more recent training will have more optimistic attitudes toward successful management of childhood obesity. We also expect to find variations in reimbursement and clinic resources, and that these will impact pediatricians' approaches.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Practicing general pediatricians
Key inclusion criteria (1 listed)
- Practicing general pediatricians
Key exclusion criteria (1 listed)
- Non practicing general pediatricians
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 |
|---|---|---|
| Identification/management of childhood obesity (behavior)In this project, we plan to conduct a national survey of pediatricians to assess common strategies for identification and management of childhood obesity, along with pediatricians' attitudes and beliefs about childhood obesity. | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Background: PubMed 9481598Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: prevalence and trends, 1960-1994. Int J Obes Relat Metab Disord. 1998 Jan;22(1):39-47. doi: 10.1038/sj.ijo.0800541.
- Background: PubMed 1133650Lauer RM, Connor WE, Leaverton PE, Reiter MA, Clarke WR. Coronary heart disease risk factors in school children: the Muscatine study. J Pediatr. 1975 May;86(5):697-706. doi: 10.1016/s0022-3476(75)80353-2.
- Background: PubMed 4687958Drash A. Relationship between diabetes mellitus and obesity in the child. Metabolism. 1973 Feb;22(2):337-44. doi: 10.1016/0026-0495(73)90185-6. No abstract available.
- Background: PubMed 5555589Londe S, Bourgoignie JJ, Robson AM, Goldring D. Hypertension in apparently normal children. J Pediatr. 1971 Apr;78(4):569-77. doi: 10.1016/s0022-3476(71)80457-2. No abstract available.
- Background: PubMed 8521169French SA, Story M, Perry CL. Self-esteem and obesity in children and adolescents: a literature review. Obes Res. 1995 Sep;3(5):479-90. doi: 10.1002/j.1550-8528.1995.tb00179.x.
- Background: PubMed 8483856Serdula MK, Ivery D, Coates RJ, Freedman DS, Williamson DF, Byers T. Do obese children become obese adults? A review of the literature. Prev Med. 1993 Mar;22(2):167-77. doi: 10.1006/pmed.1993.1014.
- Background: PubMed 9724677Barlow SE, Dietz WH. Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services. Pediatrics. 1998 Sep;102(3):E29. doi: 10.1542/peds.102.3.e29.
- BackgroundAmerican Academy of Pediatrics. Fellowship Directory. Elk Grove Village, IL: American Academy of Pediatrics., 2001.
- Background: PubMed 10228284Dietz WH, Nelson A. Barriers to the treatment of childhood obesity: a call to action. J Pediatr. 1999 May;134(5):535-6. doi: 10.1016/s0022-3476(99)70235-0. No abstract available.
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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.
Janis Mendelsohn, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Chicago 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 1 inclusion and 1 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 7 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00160914, which also lists 9 linked publications.
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 7 Apr 2016.