ObesityNCT00017706
Effectiveness of Primary Care Physicians in Delivering Weight Control Counseling
A study of Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This randomized clinical trial will determine the efficacy of physicians providing weight control advice to their overweight and obese patients in primary care practice. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obesity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento May 2001
- Phase
- Interventional
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body-Mass Index greater than or equal to 27
- Able to walk without assistance
- No untreated hypothyroidism or Cushing Disease
- No unstable medical or psychiatric condition
- No signs or symptoms of cardiovascular disease
- No history of gallstones
Show all 9Show fewer
- No terminal illness
- No other acute or chronic medical condition in which weight loss is contraindicated
- Medically cleared for physical activity
Who cannot join
- Pregnant, nursing or planning to become pregnant in the next year
- Had an in-patient hospital stay in the last 3 months
- Lost more than 10 lbs in the last 4 months
- Taking an OTC or prescribed medication for weight loss
- In treatment for an eating disorder
- In treatment for depression (if patient is on an anti-depressant and has not had a recent episode of depression in the past 3 months then he/she is eligible)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, GSPH
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Treatment of Obesity in the Primary Care Setting
This randomized clinical trial will determine the efficacy of physicians providing weight control advice to their overweight and obese patients in primary care practice.
Read the detailed description
Enrolled physicians are randomly assigned to receive brief training in either: 1) behavioral weight control intervention or 2) obesity education. Enrolled patients are asked to see their physician for 2 weight control consultations during the year to discuss their weight and physical activity. Regardless of the training the physician receives, the weight control advice is tailored to the individual patient. Patients include men and women between the ages of 21 - 70 years, with a Body-Mass Index of 27 or greater, and they have met medical and other study eligibility criteria in order to safely participate. As a participant in the trial, all patients are asked to attend an initial baseline assessment, and two follow-up assessments; 3 and 12 months after their first weight control consultation visit with their physician in order to evaluate any changes in their weight, waist circumference, physical activity, eating patterns, and mood. The findings of this important study will shed light upon the role physician advice may have in helping overweight and obese patients lose weight and become more physically active.
- Conditions
- Obesity
- Being tested
- physician-delivered weight control
- Keywords
- physician education, behavioral weight control, physician intervention, obesity counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physician-delivered weight controlBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2001 (estimated)
- Study completionMay 2001
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Laurey Simkin-Silverman, Ph.D., Principal investigator, University of Pittsburgh, GSPH, Department of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017706
- Sponsor's protocol ID
- Simkin-Silverman (completed)
- Other IDs
- DK52050
- Status last verified
- Jan 2010
- First submitted
- 7 Jun 2001
- Last updated
- 14 Jan 2010
- Results posted
- No
Publications
Simkin-Silverman LR, Wing RR. Management of obesity in primary care. Obes Res. 1997 Nov;5(6):603-12. doi: 10.1002/j.1550-8528.1997.tb00582.x.
PubMed 9449146
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obesity in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT00017706
- Acronym / sponsor ID
- Simkin-Silverman (completed)
- Conditions
- Obesity
- Keywords
- physician education, behavioral weight control, physician intervention, obesity counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study completion
- May 2001
- First posted
- 7 Jun 2001 (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.
This randomized clinical trial will determine the efficacy of physicians providing weight control advice to their overweight and obese patients in primary care practice.
Detailed description
Enrolled physicians are randomly assigned to receive brief training in either: 1) behavioral weight control intervention or 2) obesity education. Enrolled patients are asked to see their physician for 2 weight control consultations during the year to discuss their weight and physical activity. Regardless of the training the physician receives, the weight control advice is tailored to the individual patient. Patients include men and women between the ages of 21 - 70 years, with a Body-Mass Index of 27 or greater, and they have met medical and other study eligibility criteria in order to safely participate. As a participant in the trial, all patients are asked to attend an initial baseline assessment, and two follow-up assessments; 3 and 12 months after their first weight control consultation visit with their physician in order to evaluate any changes in their weight, waist circumference, physical activity, eating patterns, and mood. The findings of this important study will shed light upon the role physician advice may have in helping overweight and obese patients lose weight and become more physically active.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body-Mass Index greater than or equal to 27
- Able to walk without assistance
- No untreated hypothyroidism or Cushing Disease
- No unstable medical or psychiatric condition
- No signs or symptoms of cardiovascular disease
Key exclusion criteria (6 listed)
- Pregnant, nursing or planning to become pregnant in the next year
- Had an in-patient hospital stay in the last 3 months
- Lost more than 10 lbs in the last 4 months
- Taking an OTC or prescribed medication for weight loss
- In treatment for an eating disorder
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 |
|---|---|---|
| physician-delivered weight control | 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 14 Jan 2010.
- Background: PubMed 9449146Simkin-Silverman LR, Wing RR. Management of obesity in primary care. Obes Res. 1997 Nov;5(6):603-12. doi: 10.1002/j.1550-8528.1997.tb00582.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.
Laurey Simkin-Silverman, Ph.D. principal investigator
University of Pittsburgh, GSPH, Department of Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of 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 9 inclusion and 6 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 14 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.
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 NCT00017706, 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 14 Jan 2010.