A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
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ClinicalTrials.gov Identifier: NCT00780468
: October 27, 2008
Last Update Posted
: March 27, 2014
Medical University of South Carolina
Weight Watchers International
Information provided by (Responsible Party):
Lynne Becker, Medical University of South Carolina
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.
Condition or disease
Behavioral: Existing diet planBehavioral: New diet plan
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Ages Eligible for Study:
25 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
History of clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.
Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control.
Participation in another clinical trial within 30 days prior to enrollment.
Weight loss of more than 5 pounds for any reason over the 30 days prior to enrollment.
Taking any psychotropic medicine known to influence weight or weight loss