A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format

Medical University of South Carolina1 site in 1 country134 target enrollmentOctober 2008

ConditionsObesity Overweight

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Medical University of South Carolina
Enrollment: 134
Locations: 1
Primary Endpoint: Change in bodyweight.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will provide data on two systems for assigning point values to food choices in a diet plan. The primary purpose of this study is to compare the effectiveness of the two systems with regard to changes in body weight.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

July 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of South Carolina

Responsible Party

Principal Investigator

Lynne Becker

Project Manager

Medical University of South Carolina

Eligibility Criteria

Inclusion Criteria

•Male or female 25-65 years of age inclusive
•Body Mass Index (BMI) 27.0 -35.0 inclusive.
•Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical), sibutramine (Meridia), phentermine).
•Not currently taking any over-the-counter weight loss medications or supplement(s).
•Not currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous).
•Willing and able to commit to regular physical activity (e.g. walking) five days per week as required by study protocol.
•Willing to keep and turn in a daily log/compliance book at the times required by study protocol.
•Willingness and ability to make all scheduled appointments at MUSC as required by study protocol.
•Willingness to make weekly meetings at MUSC.

Exclusion Criteria

•History of thyroid disease, but not taking medication, or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
•Diagnosed with Type I or Type II diabetes or glucose intolerance, or use of anti-diabetic medications
•History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve).
•History of major surgery within three months of enrollment.
•History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.
•Presence of implanted cardiac defibrillator or pacemaker.
•Uncontrolled hypertension/high blood pressure.
•Orthopedic limitations that would interfere with ability to engage in regular physical activity.
•Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.
•History or presence of cancer. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment completed more than 6 months prior to enrollment.