ObesityNCT00888251
Evaluation of a Weight Management Program
An observational study of Obesity, run by Société des Produits Nestlé (SPN) at 4 sites in United States.
Trial summary
This retrospective chart review and data abstraction will evaluate and quantify the effectiveness of a comprehensive weight management program. The hypothesis is that the program will positively affect weight, weight-related comorbidities and medication use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- What is being tested?
- Comprehensive weight management program
- How many people
- 153 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2009to Jul 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: OPTIFAST Program participants
Who may be able to join
- Records of the first 40 study center participants who enrolled in the OPTIFAST Program from January 1, 2006 through June 30, 2006
- Records of subjects who completed the active weight loss phase of the program
- Records where data is available through the transitional phase of the program
Who cannot join
- Concurrent use of appetite suppressants or other weight loss medications
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Jewish Hospital Weight Management Center
Cincinnati, Ohio, 45236
Mercy Center for Weight Reduction
Des Moines, Iowa, 50309
Sparrow Weight Management Center
East Lansing, Michigan, 48823
Lutheran Weight Management Center
Fort Wayne, Indiana, 46804
About this study
Official title: A Multicenter, Retrospective Study to Evaluate the Effectiveness of the OPTIFAST Weight Management Program
This retrospective chart review and data abstraction will evaluate and quantify the effectiveness of a comprehensive weight management program. The hypothesis is that the program will positively affect weight, weight-related comorbidities and medication use.
- Conditions
- Obesity
- Being tested
- Comprehensive weight management program
- Keywords
- Obesity, Meal replacement, Obesity treatment, Weight management
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive weight management programOther
Also called OPTIFAST Program
Full meal replacement, behaviorial modification, medical monitoring, exercise.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive weight management program | Not described Receives: Other: Comprehensive weight management program |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888251
- Sponsor's protocol ID
- 08.27.CLI
- Status last verified
- Sep 2011
- First submitted
- 24 Apr 2009
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective Study to Evaluate the Effectiveness of the OPTIFAST Weight Management Program
- ClinicalTrials.gov ID
- NCT00888251
- Acronym / sponsor ID
- 08.27.CLI
- Conditions
- Obesity
- Keywords
- Obesity, Meal replacement, Obesity treatment, Weight management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 27 Apr 2009 (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 retrospective chart review and data abstraction will evaluate and quantify the effectiveness of a comprehensive weight management program. The hypothesis is that the program will positively affect weight, weight-related comorbidities and medication use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comprehensive weight management program | – | Other: Comprehensive weight management program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- OPTIFAST Program participants
Key inclusion criteria (3 listed)
- Records of the first 40 study center participants who enrolled in the OPTIFAST Program from January 1, 2006 through June 30, 2006
- Records of subjects who completed the active weight loss phase of the program
- Records where data is available through the transitional phase of the program
Key exclusion criteria (1 listed)
- Concurrent use of appetite suppressants or other weight loss medications
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 |
|---|---|---|
| Comprehensive weight management programAlso: OPTIFAST ProgramFull meal replacement, behaviorial modification, medical monitoring, exercise. | Other | Comprehensive weight management program |
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 23 Sep 2011.
Related trials for Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Société des Produits Nestlé (SPN) at 4 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 3 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 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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 23 Sep 2011.