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

This study has been completed.
Sponsor:
Collaborator:
Weight Watchers International
Information provided by (Responsible Party):
Lynne Becker, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00780468
First received: October 23, 2008
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Obesity
Overweight
Behavioral: Existing diet plan
Behavioral: New diet plan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Change in bodyweight. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in waist circumference, blood pressure, lipids, questionnaire measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Existing diet plan
Behavioral: Existing diet plan
Experimental: 2
New diet plan
Behavioral: New diet plan

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780468

Locations
United States, South Carolina
Medical University of South Carolina Weight Management Center
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Weight Watchers International
Investigators
Principal Investigator: Patrick M. O'Neil, PhD Medical University of South Carolina
  More Information

No publications provided by Medical University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lynne Becker, Project Manager, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00780468     History of Changes
Other Study ID Numbers: HR#18523
Study First Received: October 23, 2008
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Weight loss
Diet
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014