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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Existing diet plan
* Behavioral: New diet plan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Existing diet plan | Behavioral: Existing diet plan<br> <br> |
| Experimental: 2<br>New diet plan | Behavioral: New diet plan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bodyweight. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in waist circumference, blood pressure, lipids, questionnaire measures |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Diet, Obesity