ObesityPhase 2NCT00149682
Obesity Assessment and Education Through the Internet
A Phase 2 study testing 6-month educational program in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this study is to develop a web-based obesity risk assessment and counseling tool and examine its feasibility and effectiveness in improving the rate and quality of physician counseling about obesity, dietary change, and physical activity. 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?
- 6-month educational program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2007
- Phase
- Phase 2
- 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
Who may be able to join
- Received invitation from participating primary care practices
- Scheduled non-urgent appointment with their usual primary care provider
- BMI > 25 kg/m2
- Willing and able to participate in a web-based computerized self-administered questionnaire
- English-speaking
Who cannot join
- Pregnancy
- Terminal illness
- Not competent to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to develop a web-based obesity risk assessment and counseling tool and examine its feasibility and effectiveness in improving the rate and quality of physician counseling about obesity, dietary change, and physical activity.
Read the detailed description
Despite the high prevalence of obesity and its associated health risks, physicians do not address weight and behaviors that contribute to obesity because of lack of knowledge, training, and access to resources. To address these physician barriers to counseling, the investigator has developed a web-based tool that collects and integrates relevant patient clinical and behavioral information online and generates patient-specific recommendations and links to resources in the form of electronic patient and physician reports. In doing so, the tool provides physicians with a time saving device that identifies at risk patients who are motivated to make behavioral changes; at the same time, the tool provides tailored resources and recommendations that help physicians deliver more effective counseling.
The pilot study described in this application randomizes overweight primary care patients to a control group and the web-based intervention. The aims of the study are to examine the feasibility of incorporating the web-based tool into primary care practice and to collect preliminary data on its potential effectiveness on improving the rate and quality of physician-patient discussions about weight and on improving several clinical and behavioral outcomes.
- Conditions
- Obesity
- Being tested
- 6-month educational program, 6-month standard care program
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-month educational programBehavioural
6-month standard care programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician counseling about weight and weight-related behaviors
Secondary outcomes (2)
Changes in cardiovascular risk factors
Improvements in physical activity and dietary behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Christina C. Wee, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149682
- Sponsor's protocol ID
- OAEI (completed)
- Status last verified
- Jan 2010
- First submitted
- 6 Sep 2005
- Last updated
- 13 Jan 2010
- Results posted
- No
Publications
Wee CC, Davis RB, Phillips RS. Stage of readiness to control weight and adopt weight control behaviors in primary care. J Gen Intern Med. 2005 May;20(5):410-5. doi: 10.1111/j.1525-1497.2005.0074.x.
PubMed 15963162
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Assessment and Education Through the Internet
- ClinicalTrials.gov ID
- NCT00149682
- Acronym / sponsor ID
- OAEI (completed)
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jul 2005
- Study completion
- Dec 2007
- First posted
- 8 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.
The purpose of this study is to develop a web-based obesity risk assessment and counseling tool and examine its feasibility and effectiveness in improving the rate and quality of physician counseling about obesity, dietary change, and physical activity.
Detailed description
Despite the high prevalence of obesity and its associated health risks, physicians do not address weight and behaviors that contribute to obesity because of lack of knowledge, training, and access to resources. To address these physician barriers to counseling, the investigator has developed a web-based tool that collects and integrates relevant patient clinical and behavioral information online and generates patient-specific recommendations and links to resources in the form of electronic patient and physician reports. In doing so, the tool provides physicians with a time saving device that identifies at risk patients who are motivated to make behavioral changes; at the same time, the tool provides tailored resources and recommendations that help physicians deliver more effective counseling.
The pilot study described in this application randomizes overweight primary care patients to a control group and the web-based intervention. The aims of the study are to examine the feasibility of incorporating the web-based tool into primary care practice and to collect preliminary data on its potential effectiveness on improving the rate and quality of physician-patient discussions about weight and on improving several clinical and behavioral outcomes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Received invitation from participating primary care practices
- Scheduled non-urgent appointment with their usual primary care provider
- BMI > 25 kg/m2
- Willing and able to participate in a web-based computerized self-administered questionnaire
- English-speaking
Key exclusion criteria (3 listed)
- Pregnancy
- Terminal illness
- Not competent to give consent
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 |
|---|---|---|
| 6-month educational program | Behavioural | – |
| 6-month standard care program | Behavioural | – |
Primary outcome
Physician counseling about weight and weight-related behaviors
2 secondary outcomes
Changes in cardiovascular risk factors
Improvements in physical activity and dietary behavior
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 13 Jan 2010.
- Background: PubMed 15963162Wee CC, Davis RB, Phillips RS. Stage of readiness to control weight and adopt weight control behaviors in primary care. J Gen Intern Med. 2005 May;20(5):410-5. doi: 10.1111/j.1525-1497.2005.0074.x.
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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.
Christina C. Wee, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6-month educational program in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 inclusion and 3 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 13 Jan 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physician counseling about weight and weight-related behaviors. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00149682, which also lists 1 linked publication.
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 13 Jan 2010.