Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-12 @ 5:43 AM
Study NCT ID:
NCT01724905
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-11-07', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss between experimental diet (SLDm) and recommended care diet (RC)', 'timeFrame': 'Change from Baseline in Weight at 6 months', 'description': 'The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.'}, {'measure': 'Weight loss between experimental diet (SLDm) and recommended care diet (RC)', 'timeFrame': 'Change from Baseline in Weight at 18 months', 'description': 'The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.'}], 'secondaryOutcomes': [{'measure': 'Comparison of chronic disease factors - Blood Pressure', 'timeFrame': 'Change from Baseline in Blood Pressure at 18 months', 'description': 'Changes in values of blood pressure between the two groups'}, {'measure': 'Comparison of chronic disease factors - Glucose', 'timeFrame': 'Change from Baseline in Glucose at 18 months', 'description': 'Changes in values of glucose between the two groups'}, {'measure': 'Comparison of chronic disease factors - HDL', 'timeFrame': 'Change from Baseline in HDL-cholesterol Pressure at 18 months', 'description': 'Changes in values of HDL-cholesterol between the two groups'}, {'measure': 'Comparison of chronic disease factors - LDL', 'timeFrame': 'Change from Baseline in LDL-cholesterol Pressure at 18 months', 'description': 'Changes in values of LDL-cholesterol between the two groups'}, {'measure': 'Comparison of chronic disease factors - Insulin', 'timeFrame': 'Change from Baseline in Insulin Pressure at 18 months', 'description': 'Changes in values of insulin between the two groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diet', 'Obesity', 'Chronic disease'], 'conditions': ['Weight Loss']}, 'referencesModule': {'references': [{'pmid': '31944472', 'type': 'DERIVED', 'citation': 'Ptomey LT, Willis EA, Sherman JR, White DA, Donnelly JE. Exploring the effectiveness of an 18-month weight management intervention in adults with Down syndrome using propensity score matching. J Intellect Disabil Res. 2020 Mar;64(3):221-233. doi: 10.1111/jir.12713. Epub 2020 Jan 15.'}, {'pmid': '29311038', 'type': 'DERIVED', 'citation': 'Ptomey LT, Steger FL, Lee J, Sullivan DK, Goetz JR, Honas JJ, Washburn RA, Gibson CA, Donnelly JE. Changes in Energy Intake and Diet Quality during an 18-Month Weight-Management Randomized Controlled Trial in Adults with Intellectual and Developmental Disabilities. J Acad Nutr Diet. 2018 Jun;118(6):1087-1096. doi: 10.1016/j.jand.2017.11.003. Epub 2018 Jan 6.'}, {'pmid': '28707359', 'type': 'DERIVED', 'citation': 'Ptomey LT, Willis EA, Lee J, Washburn RA, Gibson CA, Honas JJ, Donnelly JE. The feasibility of using pedometers for self-report of steps and accelerometers for measuring physical activity in adults with intellectual and developmental disabilities across an 18-month intervention. J Intellect Disabil Res. 2017 Aug;61(8):792-801. doi: 10.1111/jir.12392.'}]}, 'descriptionModule': {'briefSummary': 'Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed those in the general population, consume energy dense diets, and perform very little physical activity (PA). Overweight and obesity are independent risk factors for chronic disease such as cancer, diabetes, hypertension, and cardiovascular disease in both the general population and those with IDD.\n\nThe investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week. The investigators will compare participants who use the SLDm with participants who use a reduced energy and fat diet with meal plans, based off of the current American Dietetic Association recommended car for weight reduction plan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of mile to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO)\n* Able to understand and give informed consent\n* If there is a guardian with power of attorney, both the guardian and participant must give informed consent\n* Participants must live in a supported living condition either at home or with no more than 1-4 residents and have a care giver (ie. parent, staff) who assists with food shopping, meal planning, and meal preparation\n* Overweight or obese determined by a BMI \\> 25 kg/m2\n* Able to walk\n* Clearance provided from physician\n* Able to communicate preferences\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Severe heart disease\n* Cancer diagnosis\n* Positive for HIV'}, 'identificationModule': {'nctId': 'NCT01724905', 'briefTitle': 'Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)', 'orgStudyIdInfo': {'id': '18808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Stop Light Diet', 'interventionNames': ['Dietary Supplement: Modified Stop Light Diet (SLDm)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recommended Care for Weight Reduction', 'interventionNames': ['Dietary Supplement: Recommended Care Diet']}], 'interventions': [{'name': 'Modified Stop Light Diet (SLDm)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week', 'armGroupLabels': ['Modified Stop Light Diet']}, {'name': 'Recommended Care Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'RC diet includes traditional meal plans and 35 fruits and vegetables per week', 'armGroupLabels': ['Recommended Care for Weight Reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Joseph Donnelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph Donnelly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joseph Donnelly', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}