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

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Overweight

Obesity

Treatments

Behavioral: Existing diet plan

Behavioral: New diet plan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00780468

HR#18523

Details and patient eligibility

About

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.

Enrollment

134 patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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