ObesityNCT01662830
A Retrospective Chart Review of Three Medifast Weight Control Centers
An observational study of Obesity, run by Medifast, Inc..
Trial summary
The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 \& 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 446 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Mar 2012
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study was a systematic retrospective chart review of patients participating in the Jump Start (5 \& 1) Plan at three different MWCC locations in Texas during the years 2007-2010.
Who may be able to join
- Adult males and females aged 18-70
- Followed the Jump Start (5 \& 1) Plan
- BMI ≥ 25
- Purchased a weight management program at the MWCC location in the last 3 years
- Signed patient health information consent form
Who cannot join
- On a plan other than the 5\&1 (Jump Start)
- Completed initial consultation but did not participate further
- Program stopped due to client not getting baseline labs
- Program stopped due for medical reasons unrelated to the 5 \& 1 (Jump Start) plan
- Currently an active participant at the MWCC
- No signed patient health information consent form or written request to revoke consent
About this study
Official title: Use of the Medifast Meal Replacement Program for Weight Loss in Obese Patients: A Restrospective Chart Review of Three Medifast Weight Control Centers (MWCC)
The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 \& 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.
Read the detailed description
Portion-controlled meal replacements by themselves have been shown to be an effective weight control strategy in overweight and obese individuals. The addition of medical supervision has been shown to result in greater weight loss than meal replacements alone. MWCC provides this added support through individual weekly counseling sessions. Thus, the investigators plan to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 \& 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.
- Conditions
- Obesity
- Keywords
- Obesity, Meal replacements
- 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 |
|---|---|---|
| MWCC clients | This study will be a systematic retrospective chart review of clients participating in the Jump Start (5 \& 1) Plan at three different MWCC locations in Texas during the years 2007 - 2010. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in weight
Weight loss (in pounds and percent weight loss) at weeks 4, 12, 24 and at final weight loss visit (average of 19.6 weeks).
Measured: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Changes in body composition
changes in lean muscle mass, body fat mass, and body fat percent at weeks 4, 12, 24, and final weight loss visit(average of 19.6 weeks).
Measured: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Secondary outcomes (6)
Compliance
Compliance is measured by client attendance at weekly visits, consumption of meal replacements and dietary supplements, ketone testing, and completion of food journals
Measured: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Retention rates
Retention of clients at specified time points (weeks 4, 12, 24 and final weight loss visit) and during the transition and weight maintenance phases of the MWCC weight management program
Measured: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Goal weight achievement
The percent of clients that achieve thier goal weight by their final weight loss visit(average of 19.6 weeks)
Measured: Final weight loss visit (average of 19.6 weeks)
Changes in abdominal circumference (inches)
Measured: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Maintenance of weight loss
Measured: Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program
Changes in cardiovascular risk factors
Improvements in diastolic and systolic blood pressure and pulse at weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks).
Measured: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startApr 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medifast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662830
- Sponsor's protocol ID
- MED 016
- Status last verified
- Aug 2012
- First submitted
- 3 Aug 2012
- Last updated
- 10 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
PubMed 12704397Haddock CK, Poston WS, Foreyt JP, DiBartolomeo JJ, Warner PO. Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation. Eat Weight Disord. 2008 Jun;13(2):95-101. doi: 10.1007/BF03327609.
PubMed 18612258
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Medifast Meal Replacement Program for Weight Loss in Obese Patients: A Restrospective Chart Review of Three Medifast Weight Control Centers (MWCC)
- ClinicalTrials.gov ID
- NCT01662830
- Acronym / sponsor ID
- MED 016
- Conditions
- Obesity
- Keywords
- Obesity, Meal replacements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Medifast, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 10 Aug 2012 (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 primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 \& 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.
Detailed description
Portion-controlled meal replacements by themselves have been shown to be an effective weight control strategy in overweight and obese individuals. The addition of medical supervision has been shown to result in greater weight loss than meal replacements alone. MWCC provides this added support through individual weekly counseling sessions. Thus, the investigators plan to retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 \& 1) Plan on the following indices: weight loss, anthropometric changes, and reduction in common markers of coronary heart disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MWCC clients | – | –This study will be a systematic retrospective chart review of clients participating in the Jump Start (5 \& 1) Plan at three different MWCC locations in Texas during the years 2007 - 2010. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study was a systematic retrospective chart review of patients participating in the Jump Start (5 \& 1) Plan at three different MWCC locations in Texas during the years 2007-2010.
Key inclusion criteria (5 listed)
- Adult males and females aged 18-70
- Followed the Jump Start (5 \& 1) Plan
- BMI ≥ 25
- Purchased a weight management program at the MWCC location in the last 3 years
- Signed patient health information consent form
Key exclusion criteria (6 listed)
- On a plan other than the 5\&1 (Jump Start)
- Completed initial consultation but did not participate further
- Program stopped due to client not getting baseline labs
- Program stopped due for medical reasons unrelated to the 5 \& 1 (Jump Start) plan
- Currently an active participant at the MWCC
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
Changes in weight
Time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Weight loss (in pounds and percent weight loss) at weeks 4, 12, 24 and at final weight loss visit (average of 19.6 weeks).
Changes in body composition
Time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
changes in lean muscle mass, body fat mass, and body fat percent at weeks 4, 12, 24, and final weight loss visit(average of 19.6 weeks).
6 secondary outcomes
Compliance
Time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Retention rates
Time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Goal weight achievement
Time frame: Final weight loss visit (average of 19.6 weeks)
Changes in abdominal circumference (inches)
Time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
Maintenance of weight loss
Time frame: Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program
Changes in cardiovascular risk factors
Time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
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 10 Aug 2012.
- Background: PubMed 12704397Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
- Background: PubMed 18612258Haddock CK, Poston WS, Foreyt JP, DiBartolomeo JJ, Warner PO. Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation. Eat Weight Disord. 2008 Jun;13(2):95-101. doi: 10.1007/BF03327609.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Medifast, Inc..
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 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 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in weight (time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)). The study lists 2 primary outcomes in all. 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 NCT01662830, which also lists 2 linked publications.
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 10 Aug 2012.