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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00780468
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : March 27, 2014
Sponsor:
Collaborator:
Weight Watchers International
Information provided by (Responsible Party):
Lynne Becker, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE October 23, 2008
First Posted Date  ICMJE October 27, 2008
Last Update Posted Date March 27, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2008)
Change in bodyweight. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2008)
Changes in waist circumference, blood pressure, lipids, questionnaire measures [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
Official Title  ICMJE A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Behavioral: Existing diet plan
  • Behavioral: New diet plan
Study Arms  ICMJE
  • Active Comparator: 1
    Existing diet plan
    Intervention: Behavioral: Existing diet plan
  • Experimental: 2
    New diet plan
    Intervention: Behavioral: New diet plan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2009)
134
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2008)
120
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00780468
Other Study ID Numbers  ICMJE HR#18523
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Lynne Becker, Medical University of South Carolina
Original Responsible Party Patrick O'Neil, PhD. Director, Weight Management Center, Medical University of South Carolina Weight Management Center
Current Study Sponsor  ICMJE Medical University of South Carolina
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Weight Watchers International
Investigators  ICMJE
Principal Investigator: Patrick M. O'Neil, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP