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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780468
• Other study ID #: HR#18523
• Status: Completed
• Phase: N/A
• First received: October 23, 2008
• Last updated: March 26, 2014
• Start date: October 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2014
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Existing diet plan

• New diet plan

Locations

Country	Name	City	State
United States	Medical University of South Carolina Weight Management Center	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bodyweight.		12 weeks	No
Secondary	Changes in waist circumference, blood pressure, lipids, questionnaire measures		12 weeks	No