NCT02635698

Brief Summary

Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

December 11, 2015

Last Update Submit

November 9, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Percent weight change

    Percent change in body weight between Initial Visit/Baseline and 26 weeks

    26 weeks

  • Percent weight change

    Percent change in body weight between Initial Visit/Baseline and 52 weeks

    52 weeks

Secondary Outcomes (3)

  • Ability to meet weight goals

    52 weeks

  • Change in anthropometrics

    52 weeks

  • Change in cardiometabolic outcomes

    52 weeks

Study Arms (2)

Intervention group, Optifast

EXPERIMENTAL

OPTIFAST, medically supervised weight-management program

Other: Optifast

Control group, Low-energy, low-fat

ACTIVE COMPARATOR

Food-based program, current standard of care for weight management

Other: Food-Based

Interventions

OptifastOTHER

medically-supervised weight management program

Intervention group, Optifast
Food-BasedOTHER

low-energy, low-fat diet

Control group, Low-energy, low-fat

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Alaska Premier Health

Anchorage, Alaska, 99503, United States

Location

Alexian Brothers Weight Loss Solutions

Schaumburg, Illinois, 60794, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48106, United States

Location

Brody School of Medicine, East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27401, United States

Location

Neuro-Behavioral Clinical Research, Inc.

Canton, Ohio, 44718, United States

Location

Central Ohio Nutrition Center, Inc.

Gahanna, Ohio, 43230, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Houston Center for Clinical Research

Sugar Land, Texas, 77479, United States

Location

Related Publications (1)

  • 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.

    PMID: 30421863DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2015

First Posted

December 21, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-11

Locations

US(9)