A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Medical University of South Carolina.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Medical University of South Carolina
Collaborator:
Weight Watchers International
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00780468
First received: October 23, 2008
Last updated: March 13, 2009
Last verified: March 2009
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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: | Intervention Model: Parallel Assignment |
| 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 ]
| Estimated Enrollment: | 134 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | July 2009 |
| Estimated 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
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
Additional 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: | Patrick O'Neil, PhD. Director, Weight Management Center, Medical University of South Carolina Weight Management Center |
| ClinicalTrials.gov Identifier: | NCT00780468 History of Changes |
| Other Study ID Numbers: | HR#18523 |
| Study First Received: | October 23, 2008 |
| Last Updated: | March 13, 2009 |
| 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 Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013