Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-30 @ 8:14 AM
Study NCT ID:
NCT00780468
Status:
COMPLETED
Last Update Posted:
2014-03-27
First Post:
2008-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-26', 'studyFirstSubmitDate': '2008-10-23', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2014-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bodyweight.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in waist circumference, blood pressure, lipids, questionnaire measures', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight loss', 'Diet', 'Obesity'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '24411753', 'type': 'DERIVED', 'citation': "Milsom VA, Malcolm RJ, Johnson GC, Pechon SM, Gray KM, Miller-Kovach K, Rost SL, O'Neil PM. Changes in cardiovascular risk factors with participation in a 12-week weight loss trial using a commercial format. Eat Behav. 2014 Jan;15(1):68-71. doi: 10.1016/j.eatbeh.2013.10.004. Epub 2013 Oct 21."}, {'pmid': '23121787', 'type': 'DERIVED', 'citation': "O'Neil PM, Theim KR, Boeka A, Johnson G, Miller-Kovach K. Changes in weight control behaviors and hedonic hunger during a 12-week commercial weight loss program. Eat Behav. 2012 Dec;13(4):354-60. doi: 10.1016/j.eatbeh.2012.06.002. Epub 2012 Jun 28."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female 25-65 years of age inclusive\n* Body Mass Index (BMI) 27.0 -35.0 inclusive.\n* Not currently taking a prescription medication for weight loss (e.g. orlistat (Xenical), sibutramine (Meridia), phentermine).\n* Not currently taking any over-the-counter weight loss medications or supplement(s).\n* Not currently enrolled in commercial weight loss program (e.g. Jenny Craig, Weight Watchers) or self-help group (e.g. TOPS, Overeaters Anonymous).\n* Willing and able to commit to regular physical activity (e.g. walking) five days per week as required by study protocol.\n* Willing to keep and turn in a daily log/compliance book at the times required by study protocol.\n* Willingness and ability to make all scheduled appointments at MUSC as required by study protocol.\n* Willingness to make weekly meetings at MUSC.\n\nExclusion Criteria:\n\n* 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.\n* Diagnosed with Type I or Type II diabetes or glucose intolerance, or use of anti-diabetic medications\n* 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).\n* History of major surgery within three months of enrollment.\n* History of heart problems (e.g. angina, bypass surgery, MI, etc.) within three months prior to enrollment.\n* Presence of implanted cardiac defibrillator or pacemaker.\n* Uncontrolled hypertension/high blood pressure.\n* Orthopedic limitations that would interfere with ability to engage in regular physical activity.\n* Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease.\n* 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.\n* History of clinically diagnosed eating disorders including anorexia nervosa or bulimia nervosa.\n* Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control.\n* Participation in another clinical trial within 30 days prior to enrollment.\n* Weight loss of more than 5 pounds for any reason over the 30 days prior to enrollment.\n* Taking any psychotropic medicine known to influence weight or weight loss"}, 'identificationModule': {'nctId': 'NCT00780468', 'briefTitle': 'A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'A Pilot Study to Evaluate a Revised Method of Assessing Food in a Commercial Weight Management Program Format', 'orgStudyIdInfo': {'id': 'HR#18523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Existing diet plan', 'interventionNames': ['Behavioral: Existing diet plan']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'New diet plan', 'interventionNames': ['Behavioral: New diet plan']}], 'interventions': [{'name': 'Existing diet plan', 'type': 'BEHAVIORAL', 'armGroupLabels': ['1']}, {'name': 'New diet plan', 'type': 'BEHAVIORAL', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina Weight Management Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': "Patrick M. O'Neil, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'WW International Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Manager', 'investigatorFullName': 'Lynne Becker', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}