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

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

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.

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.
• 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