Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04222894
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2020-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hospital Workplace Nutrition Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D000067269', 'term': 'Diet, Vegan'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D014676', 'term': 'Diet, Vegetarian'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '12 weeks', 'description': 'Anticipated weight-loss for intervention group compared with control group'}, {'measure': 'Blood Pressure', 'timeFrame': '12 weeks', 'description': 'Anticipated changes in blood pressure (systolic and diastolic) for intervention group compared with control group'}, {'measure': 'Plasma Lipids', 'timeFrame': '12 weeks', 'description': 'Anticipated changes in plasma lipid concentrations for intervention group compared with control group'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin A1c', 'timeFrame': '12 weeks', 'description': 'HbA1c will be measured as an index of glycemic control.'}, {'measure': 'Fasting Plasma Glucose', 'timeFrame': '12 weeks', 'description': 'Fasting Plasma Glucose will be measured as an index of glycemic control.'}, {'measure': 'Absenteeism', 'timeFrame': '12 weeks', 'description': 'Absenteeism from work will be assessed by self-report at baseline and final assessments.'}, {'measure': 'Quality of Life: SF-36', 'timeFrame': '12 weeks', 'description': 'Quality of life will be assessed using the SF-36, which is a brief health survey with 36 questions. The SF-36 provides an 8-scale profile of functional health and well-being scores, as well as psychometrically-based physical and mental health summary measures. The SF-36 is a general measure that has been administered across various age groups, disease spectra, and treatment regimens. Items on the SF-36 are scored on a scale of 0-100, with a higher score indicating better health-related quality of life.'}, {'measure': 'Dietary Restraint, Disinhibition, Hunger', 'timeFrame': '12 weeks', 'description': 'Participants will complete an Eating Inventory form, a highly reliable 51 item questionnaire providing quantitative measures of dietary restraint (21 questions), disinhibition (16 items), and hunger (14 questions). Scores for each sub-scale are calculated by summing respective items. The scale consists of 36 true=false items and 15 forced-choice format questions. Higher scores are indicative of greater dietary restraint, disinhibition and hunger. Its principal use in the current study will be as a gauge of ease in adapting to the intervention diet, which is indicated by changes in restraint and hunger scores.'}, {'measure': 'Food Acceptability: The Food Acceptability Questionnaire', 'timeFrame': '12 weeks', 'description': 'The Food Acceptability Questionnaire will measure attitudes about the intervention diet, including desire to adhere, likelihood to adhere in the future, and attitudes about accessibility of sustaining the diet. Items on the FAQ are scored on a scale of 1-7. Higher scores indicate greater food acceptability.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['body weight', 'blood pressure', 'lipids', 'nutrition'], 'conditions': ['Overweight', 'Type2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '12365955', 'type': 'BACKGROUND', 'citation': 'Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.'}, {'pmid': '15199035', 'type': 'BACKGROUND', 'citation': 'Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.'}, {'pmid': '24512862', 'type': 'BACKGROUND', 'citation': 'Luckhaupt SE, Cohen MA, Li J, Calvert GM. Prevalence of obesity among U.S. workers and associations with occupational factors. Am J Prev Med. 2014 Mar;46(3):237-48. doi: 10.1016/j.amepre.2013.11.002.'}, {'pmid': '26422242', 'type': 'BACKGROUND', 'citation': 'Dayoub E, Jena AB. Chronic Disease Prevalence and Healthy Lifestyle Behaviors Among US Health Care Professionals. Mayo Clin Proc. 2015 Dec;90(12):1659-62. doi: 10.1016/j.mayocp.2015.08.002. Epub 2015 Oct 5.'}, {'pmid': '30613543', 'type': 'BACKGROUND', 'citation': 'Vibhute NA, Baad R, Belgaumi U, Kadashetti V, Bommanavar S, Kamate W. Dietary habits amongst medical students: An institution-based study. J Family Med Prim Care. 2018 Nov-Dec;7(6):1464-1466. doi: 10.4103/jfmpc.jfmpc_154_18.'}, {'pmid': '29200450', 'type': 'BACKGROUND', 'citation': "Bergeron N, Al-Saiegh S, Ip EJ. An Analysis of California Pharmacy and Medical Students' Dietary and Lifestyle Practices. Am J Pharm Educ. 2017 Oct;81(8):5956. doi: 10.5688/ajpe5956."}, {'pmid': '22262162', 'type': 'BACKGROUND', 'citation': 'Bleich SN, Bennett WL, Gudzune KA, Cooper LA. Impact of physician BMI on obesity care and beliefs. Obesity (Silver Spring). 2012 May;20(5):999-1005. doi: 10.1038/oby.2011.402. Epub 2012 Jan 19.'}, {'pmid': '10760336', 'type': 'BACKGROUND', 'citation': 'Barnard ND, Scialli AR, Bertron P, Hurlock D, Edmonds K, Talev L. Effectiveness of a low-fat vegetarian diet in altering serum lipids in healthy premenopausal women. Am J Cardiol. 2000 Apr 15;85(8):969-72. doi: 10.1016/s0002-9149(99)00911-x.'}, {'pmid': '24566947', 'type': 'BACKGROUND', 'citation': 'Yokoyama Y, Nishimura K, Barnard ND, Takegami M, Watanabe M, Sekikawa A, Okamura T, Miyamoto Y. Vegetarian diets and blood pressure: a meta-analysis. JAMA Intern Med. 2014 Apr;174(4):577-87. doi: 10.1001/jamainternmed.2013.14547.'}, {'pmid': '16873779', 'type': 'BACKGROUND', 'citation': 'Barnard ND, Cohen J, Jenkins DJ, Turner-McGrievy G, Gloede L, Jaster B, Seidl K, Green AA, Talpers S. A low-fat vegan diet improves glycemic control and cardiovascular risk factors in a randomized clinical trial in individuals with type 2 diabetes. Diabetes Care. 2006 Aug;29(8):1777-83. doi: 10.2337/dc06-0606.'}, {'pmid': '10496449', 'type': 'BACKGROUND', 'citation': 'Esselstyn CB Jr. Updating a 12-year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology). Am J Cardiol. 1999 Aug 1;84(3):339-41, A8. doi: 10.1016/s0002-9149(99)00290-8.'}, {'pmid': '7500065', 'type': 'BACKGROUND', 'citation': "Esselstyn CB Jr, Ellis SG, Medendorp SV, Crowe TD. A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice. J Fam Pract. 1995 Dec;41(6):560-8."}, {'pmid': '1973470', 'type': 'BACKGROUND', 'citation': 'Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u.'}, {'pmid': '19562864', 'type': 'BACKGROUND', 'citation': 'Craig WJ, Mangels AR; American Dietetic Association. Position of the American Dietetic Association: vegetarian diets. J Am Diet Assoc. 2009 Jul;109(7):1266-82. doi: 10.1016/j.jada.2009.05.027.'}, {'pmid': '4337382', 'type': 'BACKGROUND', 'citation': 'Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.'}, {'pmid': '26230264', 'type': 'BACKGROUND', 'citation': 'Loffler A, Luck T, Then FS, Sikorski C, Kovacs P, Bottcher Y, Breitfeld J, Tonjes A, Horstmann A, Loffler M, Engel C, Thiery J, Villringer A, Stumvoll M, Riedel-Heller SG. Eating Behaviour in the General Population: An Analysis of the Factor Structure of the German Version of the Three-Factor-Eating-Questionnaire (TFEQ) and Its Association with the Body Mass Index. PLoS One. 2015 Jul 31;10(7):e0133977. doi: 10.1371/journal.pone.0133977. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.', 'detailedDescription': 'Using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. T Before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Employee of Sibley hospital\n2. Male or female\n3. Age at least 18 years\n4. Have a BMI \\>25 kg/m2\n5. Ability and willingness to participate in all components of the study\n6. A willingness to follow a plant-based diet for the duration of the study\n7. A willingness to attend weekly classes for the duration of the study\n8. A willingness to keep physical activity level consistent throughout the duration of the study\n\nExclusion Criteria:\n\n1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome\n2. Smoking during the past six months\n3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use\n4. Current or unresolved past drug abuse\n5. Pregnancy or plans to become pregnant in the next 12 weeks\n6. Intention to leave hospital employment in the next 12 weeks\n7. Unstable medical or psychiatric status\n8. Evidence of an eating disorder\n9. Lack of English fluency\n10. Inability to maintain current medication regimen"}, 'identificationModule': {'nctId': 'NCT04222894', 'briefTitle': 'Hospital Workplace Nutrition Study', 'organization': {'class': 'OTHER', 'fullName': 'Physicians Committee for Responsible Medicine'}, 'officialTitle': 'Hospital Workplace Nutrition Study (Sibley Memorial Hospital)', 'orgStudyIdInfo': {'id': 'Pro00038823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plant-based diet', 'description': 'The diet group will be asked to follow a low-fat, vegan diet for 12 weeks', 'interventionNames': ['Other: Plant-based diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control diet', 'description': 'Half of the participants will be asked to continue their usual diets for the 12-week study period.', 'interventionNames': ['Other: Control Diet']}], 'interventions': [{'name': 'Plant-based diet', 'type': 'OTHER', 'otherNames': ['Vegan diet'], 'description': 'Weekly instructions will be given to the participants in the intervention group about following vegan diet.', 'armGroupLabels': ['Plant-based diet']}, {'name': 'Control Diet', 'type': 'OTHER', 'description': 'Participants will be asked to continue their usual diets for the 12-week study period.', 'armGroupLabels': ['Control diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Sibley Memorial Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Neal D Barnard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'President'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Physicians Committee for Responsible Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sibley Memorial Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}