ObesityOpti-WINNCT02635698
Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
A study testing Optifast and Food-Based in people with Obesity, run by Société des Produits Nestlé (SPN) at 9 sites in United States.
Trial summary
Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Optifast and Food-Based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 9 sitesUnited States
- Study dates
- Nov 2015to Oct 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males and females between 18 and 70 years
- Obese (BMI > 30 kg/m2 and 55 kg/m2)
- Non-smokers or smoking cessation > 6 months
- < 14 alcoholic beverages per week
- Willing and able to give informed consent
Who cannot join
- Active participation in any weight loss program within previous 3 months
- Weight changes of > 5% body weight within previous 3 months
- Participated in an Optifast program within prior 5 years
- Prior bariatric surgery or liposuction
- Use of any medication prescribed for weight loss in the past 3 months
- Current major disease or GI disease that is poorly controlled (Crohn's, ulcerative colitis)
Show all 27Show fewer
- Type 1 DM
- Current ESRD
- Current COPD
- Any major or active hepatic disease requiring inpatient or outpatient treatment
- History of acute pancreatitis in the past year
- Active cancer treatment in the past 2 years other than non-malignant skin cancers
- Uncontrolled hypertension (Blood pressure 160/100 or greater)
- Hemoglobin A1c > 10%
- Recent CV event in past 6 months
- Pregnancy, childbirth, or nursing within prior 6 months
- Eating Attitudes Test (EAT-26) > 30
- Current major depressive disorder with Center for Epidemiological Studies Depression Scale-Revised (CESD-R) score > 16
- Schizophrenia, history of bipolar disorder
- Recent hospitalization for psychiatric illness in past 6 months
- Dependence on alcohol or sedative-hypnotic drugs
- Intolerance or allergy to Optifast product
- Unable to read/speak English
- Orthopedic limitation preventing participation in regular physical activity
- Untreated thyroid disease, abnormal TSH, non on stable dose of hormone replacement for hyperthyroidism
- Major surgery defined as any surgical procedure that might require prolonged convalescence or limit participation in the program in any way
- Inability to complete the 7-day run-in satisfactorily
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Alaska Premier Health
Anchorage, Alaska, 99503
University of Michigan Health System
Ann Arbor, Michigan, 48106
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Central Ohio Nutrition Center, Inc.
Gahanna, Ohio, 43230
Brody School of Medicine, East Carolina University
Greenville, North Carolina, 27834
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Alexian Brothers Weight Loss Solutions
Schaumburg, Illinois, 60794
Houston Center for Clinical Research
Sugar Land, Texas, 77479
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27401
About this study
Official title: Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program
- Conditions
- Obesity
- Being tested
- Optifast, Food-Based
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptifastOther
medically-supervised weight management program
Food-BasedOther
low-energy, low-fat diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention group, Optifast | Experimental | OPTIFAST, medically supervised weight-management program Receives: Other: Optifast |
| Control group, Low-energy, low-fat | Active comparator | Food-based program, current standard of care for weight management Receives: Other: Food-Based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent weight change
Percent change in body weight between Initial Visit/Baseline and 26 weeks
Measured: 26 weeks
Percent weight change
Percent change in body weight between Initial Visit/Baseline and 52 weeks
Measured: 52 weeks
Secondary outcomes (3)
Ability to meet weight goals
Percentage of subjects meeting short- and long-term weight loss goals
Measured: 52 weeks
Change in anthropometrics
change in BMI in kg/m^2 from baseline to 52 weeks
Measured: 52 weeks
Change in cardiometabolic outcomes
Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2017
- Study completionOct 2017
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.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635698
- Sponsor's protocol ID
- 14.21.CLI
- Acronym
- Opti-WIN
- Status last verified
- Nov 2017
- First submitted
- 11 Dec 2015
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ard JD, Lewis KH, Rothberg A, Auriemma A, Coburn SL, Cohen SS, Loper J, Matarese L, Pories WJ, Periman S. Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study. Obesity (Silver Spring). 2019 Jan;27(1):22-29. doi: 10.1002/oby.22303. Epub 2018 Nov 13.
PubMed 30421863
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight
- ClinicalTrials.gov ID
- NCT02635698
- Acronym / sponsor ID
- Opti-WIN / 14.21.CLI
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- Nov 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Dec 2015 (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.
Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group, Optifast | Experimental | Other: OptifastOPTIFAST, medically supervised weight-management program |
| Control group, Low-energy, low-fat | Active comparator | Other: Food-BasedFood-based program, current standard of care for weight management |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult males and females between 18 and 70 years
- Obese (BMI > 30 kg/m2 and 55 kg/m2)
- Non-smokers or smoking cessation > 6 months
- < 14 alcoholic beverages per week
- Willing and able to give informed consent
Key exclusion criteria (27 listed)
- Active participation in any weight loss program within previous 3 months
- Weight changes of > 5% body weight within previous 3 months
- Participated in an Optifast program within prior 5 years
- Prior bariatric surgery or liposuction
- Use of any medication prescribed for weight loss in the past 3 months
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 |
|---|---|---|
| Optifastmedically-supervised weight management program | Other | Intervention group, Optifast |
| Food-Basedlow-energy, low-fat diet | Other | Control group, Low-energy, low-fat |
Primary outcome
Percent weight change
Time frame: 26 weeks
Percent change in body weight between Initial Visit/Baseline and 26 weeks
Percent weight change
Time frame: 52 weeks
Percent change in body weight between Initial Visit/Baseline and 52 weeks
3 secondary outcomes
Ability to meet weight goals
Time frame: 52 weeks
Change in anthropometrics
Time frame: 52 weeks
Change in cardiometabolic outcomes
Time frame: 52 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 13 Nov 2017.
- Derived from this study: PubMed 30421863Ard JD, Lewis KH, Rothberg A, Auriemma A, Coburn SL, Cohen SS, Loper J, Matarese L, Pories WJ, Periman S. Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study. Obesity (Silver Spring). 2019 Jan;27(1):22-29. doi: 10.1002/oby.22303. Epub 2018 Nov 13.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optifast and Food-Based in people with Obesity, run by Société des Produits Nestlé (SPN) at 9 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 5 inclusion and 27 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Percent weight change (time frame: 26 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 NCT02635698, 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 Nov 2017.