Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight (Opti-WIN)

November 9, 2017 updated by: Nestlé

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Premier Health
    • Illinois
      • Schaumburg, Illinois, United States, 60794
        • Alexian Brothers Weight Loss Solutions
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan Health System
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medicine, East Carolina University
      • Winston-Salem, North Carolina, United States, 27401
        • Wake Forest School of Medicine
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Gahanna, Ohio, United States, 43230
        • Central Ohio Nutrition Center, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Sugar Land, Texas, United States, 77479
        • Houston Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group, Optifast
OPTIFAST, medically supervised weight-management program
Other: Optifast
medically-supervised weight management program
Active Comparator: Control group, Low-energy, low-fat
Food-based program, current standard of care for weight management
Other: Food-Based
low-energy, low-fat diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent weight change
Time Frame: 26 weeks
Percent change in body weight between Initial Visit/Baseline and 26 weeks
26 weeks
Percent weight change
Time Frame: 52 weeks
Percent change in body weight between Initial Visit/Baseline and 52 weeks
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ability to meet weight goals
Time Frame: 52 weeks
Percentage of subjects meeting short- and long-term weight loss goals
52 weeks
Change in anthropometrics
Time Frame: 52 weeks
change in BMI in kg/m^2 from baseline to 52 weeks
52 weeks
Change in cardiometabolic outcomes
Time Frame: 52 weeks
Change in 10-year cardiovascular risk score (% likelihood to develop CVD in 10 years)
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nestlé

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TKL Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14.21.CLI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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