ObesityGEISONCT01160146
Geisinger Education Intervention Study in Obesity Protocol
An observational study of Obesity, run by Geisinger Clinic at 1 site in United States.
Trial summary
Overweight and obesity has become an epidemic which warrants more aggressive treatment. However, few primary care physicians (PCPs) address this issue or do not possess adequate education regarding treatment modalities such as nutrition counseling or bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 2015
- 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: Geisinger's General Internal Medicine Primary Care Clinic Geisinger's Family Medicine Primary Care Clinic
Who may be able to join
- Geisinger General Internal and Family Medicine PCPs (include physician, physical assistants and CRNP):
- PCP must be active between May 2008 - May 2009
- Average patient age between 30-60 (no individual patients will be identified using personal identification)
- Minimum of 100 patients assigned to PC
Who cannot join
- PCPs from clinics/departments other than General Internal Medicine or Family Medicine will be excluded from the analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
Overweight and obesity has become an epidemic which warrants more aggressive treatment. However, few primary care physicians (PCPs) address this issue or do not possess adequate education regarding treatment modalities such as nutrition counseling or bariatric surgery. The primary goal of this study will be to determine whether the referrals for weight management can be influenced through obesity education.
Read the detailed description
Evaluation of educational interventions focusing on the treatment of obesity will include in person CME sessions, interactive game/virtual patient computer software and two 30 minute DVD/Web-based CME opportunities that the physicians can review at their leisure. These educational interventions were not completed as part of this research.
A control group will be comprised of those healthcare professionals who did not complete the CME survey.
Completion of the post education survey would be completed even if there was no study. The reward given to PCP's (free enrollment in CME session and either lab coat or $40 CME credit) was given for clinical purposes only and not for research. The study consists of the collection of PCP referral rates prior to the educational opportunity and then after the CME looking for a change to referral rates.
In June of 2009, an Obesity Educational Intervention Summit was attended by PCPs. This research seeks approval to perform data pulls consisting of referrals from their practice to the GI/Nutrition Clinic for potential bariatric surgery evaluation.
The information to be collected regarding the primary care providers' referral rates will be collected by a CDIS data pull by a data broker. The biostatistician will link survey responses to referral patterns and education type and will be true, only individual to have access to direct identifiers and in turn will provide PI and study team with de-identified summary data.
- Conditions
- Obesity
- Keywords
- Obestiy, Over weight, referral patterns, Continuing Medical Education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Clinicians provide lifestyle management counseling regarding healthful lifestyle behaviors and daily physical activity. 1. Logging foods for accountability and counting calories 2. Close attention to portion control and appropriate serving sizes of foods consumed 3. Consumption of appropriate calorie and sugar free beverages 4. Good meal distribution and avoidance of meal skipping 5. Balance of food groups using the MyPlate concept (USDA Choose My Plate)-inclusion of all food groups with emphasis on fruits, vegetables, whole grains, low-fat dairy products and lean meat/fish/poultry 6. Increasing physical activity with reasonable, sustainable exercise or activity. Working toward a goal of at least 30 minutes, 5 days per week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of weight management referral rates and attitudes/barriers towards obesity
Referral rates to a weight management clinic will be evaluated and correlated with clinicians attitudes towards treatment of obesity (as assessed by questionnaire).
Measured: Referral rates are calculated over the course of one year
Secondary outcomes (1)
Change in referral rate by Continuing Medical Education and change in referral rate by clinician characteristic
Compare change in Weight Management clinic referral rates between clinicians that attend in-person Continuing Medical Education versus those that complete an innovative gaming system Continuing Medical Education versus those that complete a web-based Continuing Medical Education and evaluate the correlation between changing Weight Management clinic referral rates and clinician characteristics such as attitudes towards obesity, clinician age/gender, number of patients, age/gender of patients, and percent of patients that are obese.
Measured: Compare rates of referral in year prior to Continuing Medical Education versus one year after Continuing Medical Education and compare rates of referral in consecutive years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startAug 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Sponsor
- Investigators
- Christopher D Still, DO, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160146
- Sponsor's protocol ID
- 2009-0296
- Acronym
- GEISO
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2010
- Last updated
- 17 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geisinger Education Intervention Study in Obesity Protocol
- ClinicalTrials.gov ID
- NCT01160146
- Acronym / sponsor ID
- GEISO / 2009-0296
- Conditions
- Obesity
- Keywords
- Obestiy, Over weight, referral patterns, Continuing Medical Education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Aug 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Jul 2010 (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.
Overweight and obesity has become an epidemic which warrants more aggressive treatment. However, few primary care physicians (PCPs) address this issue or do not possess adequate education regarding treatment modalities such as nutrition counseling or bariatric surgery. The primary goal of this study will be to determine whether the referrals for weight management can be influenced through obesity education.
Detailed description
Evaluation of educational interventions focusing on the treatment of obesity will include in person CME sessions, interactive game/virtual patient computer software and two 30 minute DVD/Web-based CME opportunities that the physicians can review at their leisure. These educational interventions were not completed as part of this research.
A control group will be comprised of those healthcare professionals who did not complete the CME survey.
Completion of the post education survey would be completed even if there was no study. The reward given to PCP's (free enrollment in CME session and either lab coat or $40 CME credit) was given for clinical purposes only and not for research. The study consists of the collection of PCP referral rates prior to the educational opportunity and then after the CME looking for a change to referral rates.
In June of 2009, an Obesity Educational Intervention Summit was attended by PCPs. This research seeks approval to perform data pulls consisting of referrals from their practice to the GI/Nutrition Clinic for potential bariatric surgery evaluation.
The information to be collected regarding the primary care providers' referral rates will be collected by a CDIS data pull by a data broker. The biostatistician will link survey responses to referral patterns and education type and will be true, only individual to have access to direct identifiers and in turn will provide PI and study team with de-identified summary data.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | – | –Clinicians provide lifestyle management counseling regarding healthful lifestyle behaviors and daily physical activity. 1. Logging foods for accountability and counting calories 2. Close attention to portion control and appropriate serving sizes of foods consumed 3. Consumption of appropriate calorie and sugar free beverages 4. Good meal distribution and avoidance of meal skipping 5. Balance of food groups using the MyPlate concept (USDA Choose My Plate)-inclusion of all food groups with emphasis on fruits, vegetables, whole grains, low-fat dairy products and lean meat/fish/poultry 6. Increasing physical activity with reasonable, sustainable exercise or activity. Working toward a goal of at least 30 minutes, 5 days per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Geisinger's General Internal Medicine Primary Care Clinic Geisinger's Family Medicine Primary Care Clinic
Key inclusion criteria (4 listed)
- Geisinger General Internal and Family Medicine PCPs (include physician, physical assistants and CRNP):
- PCP must be active between May 2008 - May 2009
- Average patient age between 30-60 (no individual patients will be identified using personal identification)
- Minimum of 100 patients assigned to PC
Key exclusion criteria (1 listed)
- PCPs from clinics/departments other than General Internal Medicine or Family Medicine will be excluded from the analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of weight management referral rates and attitudes/barriers towards obesity
Time frame: Referral rates are calculated over the course of one year
Referral rates to a weight management clinic will be evaluated and correlated with clinicians attitudes towards treatment of obesity (as assessed by questionnaire).
1 secondary outcome
Change in referral rate by Continuing Medical Education and change in referral rate by clinician characteristic
Time frame: Compare rates of referral in year prior to Continuing Medical Education versus one year after Continuing Medical Education and compare rates of referral in consecutive years
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 17 Aug 2015.
- Geisinger Health SystemLink provided by the sponsor.
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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.
Christopher D Still, DO principal investigator
Geisinger Clinic
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 Geisinger Clinic 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 4 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 17 Aug 2015. 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.
What does the primary outcome measure?
Correlation of weight management referral rates and attitudes/barriers towards obesity (time frame: Referral rates are calculated over the course of one year). 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 17 Aug 2015.