NCT00888251

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

4 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

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 23, 2011

Status Verified

September 1, 2011

Enrollment Period

4 months

First QC Date

April 24, 2009

Last Update Submit

September 21, 2011

Conditions

Obesity

Keywords

ObesityMeal replacementObesity treatmentWeight management

Study Arms (1)

Comprehensive weight management program

Other: Comprehensive weight management program

Interventions

Comprehensive weight management programOTHER

Full meal replacement, behaviorial modification, medical monitoring, exercise.

Also known as: OPTIFAST Program
Comprehensive weight management program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

OPTIFAST Program participants

You may qualify if:

  • 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

You may not qualify if:

  • Concurrent use of appetite suppressants or other weight loss medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lutheran Weight Management Center

Fort Wayne, Indiana, 46804, United States

Location

Mercy Center for Weight Reduction

Des Moines, Iowa, 50309, United States

Location

Sparrow Weight Management Center

East Lansing, Michigan, 48823, United States

Location

Jewish Hospital Weight Management Center

Cincinnati, Ohio, 45236, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 23, 2011

Record last verified: 2011-09

Locations

US(4)