ObesityNCT00471172
Study of Five Different Methods Of Delivering A Lifestyle Modification Program for Weight Loss
A study testing Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week), Face-to-face counseling by a dietitian (monthly) and Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week) in people with Obesity, run by Pfizer at 12 sites in United States.
Trial summary
The aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week), Face-to-face counseling by a dietitian (monthly) and Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 350 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2004to May 2005
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and <40 kg/m2.
- 2- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert
- 3- Willingness and ability to comply with study related procedures
- 4- Access to Internet and email
Who cannot join
- Uncontrolled blood pressure (defined as ≥140/90 mmHg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. Women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Clearwater, Florida
Pfizer Investigational Site
Harleysville, Pennsylvania
Pfizer Investigational Site
Kissimmee, Florida
Pfizer Investigational Site
Lexington, Kentucky
Pfizer Investigational Site
Los Angeles, California
Pfizer Investigational Site
Louisville, Kentucky
Pfizer Investigational Site
Milford, Massachusetts
Pfizer Investigational Site
Milwaukee, Wisconsin
Pfizer Investigational Site
Nashville, Tennessee
Pfizer Investigational Site
Pembroke Pines, Florida
Pfizer Investigational Site
Warwick, Rhode Island
About this study
Official title: A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity
The aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.
- Conditions
- Obesity
- Being tested
- Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week), Face-to-face counseling by a dietitian (monthly), Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week), Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week), Self help
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week)Behavioural
Face-to-face counseling by a dietitian (monthly)Behavioural
Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week)Behavioural
Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week)Behavioural
Self helpBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight at 6 months.
Secondary outcomes (1)
Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startAug 2004
- Study completionMay 2005
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.
- More trials run by PfizerThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471172
- Sponsor's protocol ID
- A9001187
- Status last verified
- Sep 2008
- First submitted
- 7 May 2007
- Last updated
- 15 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity
- ClinicalTrials.gov ID
- NCT00471172
- Acronym / sponsor ID
- A9001187
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- May 2005 (actual)
- First posted
- 9 May 2007 (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 aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and <40 kg/m2.
- 2- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert
- 3- Willingness and ability to comply with study related procedures
- 4- Access to Internet and email
Key exclusion criteria (1 listed)
- Uncontrolled blood pressure (defined as ≥140/90 mmHg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. Women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.
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 |
|---|---|---|
| Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week) | Behavioural | – |
| Face-to-face counseling by a dietitian (monthly) | Behavioural | – |
| Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week) | Behavioural | – |
| Counseling by a dietitian via e-mail (months 1-3: weekly, months 4-6: every other week) | Behavioural | – |
| Self help | Behavioural | – |
Primary outcome
Percentage change in body weight at 6 months.
1 secondary outcome
Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
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 15 Sep 2008.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face counseling by a dietitian (months 1-3: weekly, months 4-6: every other week), Face-to-face counseling by a dietitian (monthly) and Counseling by a dietitian via telephone (months 1-3: weekly, months 4-6: every other week) in people with Obesity, run by Pfizer at 12 sites 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 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Percentage change in body weight at 6 months.. 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 15 Sep 2008.