A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
Not Applicable
Completed
- Conditions
- ObesityOverweight
- Interventions
- Behavioral: Existing diet planBehavioral: New diet plan
- Registration Number
- NCT00780468
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Existing diet plan Existing diet plan 2 New diet plan New diet plan
- Primary Outcome Measures
Name Time Method Change in bodyweight. 12 weeks
- Secondary Outcome Measures
Name Time Method Changes in waist circumference, blood pressure, lipids, questionnaire measures 12 weeks
Trial Locations
- Locations (1)
Medical University of South Carolina Weight Management Center
🇺🇸Charleston, South Carolina, United States