Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT01685957
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2012-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Dietary Treatment of Obese Adults
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': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-12', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'From week 0 to week 52'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'From week 0 to week 52', 'description': 'Both systolic and diastolic blood pressure'}, {'measure': 'Dexa-scan (body composition)', 'timeFrame': 'From week 0 to week 52'}, {'measure': 'Waist circumference', 'timeFrame': 'From week 0 to week 52'}, {'measure': 'Biomarkers in blood samples', 'timeFrame': 'From week 0 to week 52', 'description': 'Lipid profile (total-cholesterol, LDL, HDL, triglyceride), fasting-glucose, HbA1c'}, {'measure': 'Quality of life', 'timeFrame': 'From week 0 to week 52', 'description': 'EQ-5D-5L'}, {'measure': 'Dietary intake', 'timeFrame': 'From week 0 to week 52', 'description': 'Diet records'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight loss', 'Dietary intervention', 'Self-help book', 'Cooking', 'Dietitian', 'Dietary therapy'], 'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'Recent decades have shown an alarming increase in obesity. Obesity is associated with high costs for both the individual and for society. It is therefore important to prevent and treat obesity. The investigators believe that if you add a self-help weightloss book and teach cooking skills to a standard dietary treatment, then it will result in greater weight loss than with dietary treatment alone. However, this has not yet been studied. Since it will require more resources, it is important to investigate whether it also works better before changing the current treatment.\n\nHypothesis: Conventional dietary treatment supplemented with a self-help weightloss book and cooking classes are more effective than dietary treatment alone in changes in body weight and body composition in obese persons over a period of 12 months. There is no difference if the intervention are based on the national dietary guidelines or a relative low-gi and high-protein diet.\n\nSecondary to investigate the impact the interventions have; on diet quality and quantity, on markers of metabolic syndrome and on how many subjects complete the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 25\n* Waist: female ≥ 88 cm; male ≥ 102 cm)\n* Stable weight for the past three month (+- 5 kilogram)\n* Motivated to make changes in their dietary habits\n\nExclusion Criteria:\n\n* Waist \\> 150 cm\n* Significant cardiovascular, renal or endocrine disease\n* Psychiatric history\n* Treatment with steroids\n* Alcohol- or drug-addiction\n* Pregnancy or lactation\n* Obesity surgery'}, 'identificationModule': {'nctId': 'NCT01685957', 'acronym': 'OPDIOS', 'briefTitle': 'Optimal Dietary Treatment of Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Hospitalsenheden Vest'}, 'officialTitle': 'Optimal Dietary Treatment of Obese Adults', 'orgStudyIdInfo': {'id': 'ASC-01-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dietary treatment (STD)', 'description': 'Dietary treatment - 6 individual sessions with a registered dietitian', 'interventionNames': ['Behavioral: Standard dietary treatment (STD)']}, {'type': 'EXPERIMENTAL', 'label': '"Ned i vaegt" (NIV)', 'description': 'Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.', 'interventionNames': ['Behavioral: "Ned i vaegt" (NIV)']}, {'type': 'EXPERIMENTAL', 'label': '"Verdens bedste kur" (VBK)', 'description': 'Dietary treatment - 3 individual sessions and 3 group sessions. All sessions with a registered dietitian.', 'interventionNames': ['Behavioral: "Verdens bedste kur" (VBK)']}], 'interventions': [{'name': 'Standard dietary treatment (STD)', 'type': 'BEHAVIORAL', 'description': "This group will receive 6 one-on-one sessions with a registered dietitian. Total time spent is 6½ hour. Dietary treatment is based national guidelines and counseling is individualized and tailored to the patient's needs and goals.", 'armGroupLabels': ['Standard dietary treatment (STD)']}, {'name': '"Ned i vaegt" (NIV)', 'type': 'BEHAVIORAL', 'description': 'This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on the national dietary guidelines. Focus is to learn to make "normal" danish dishes in a more healthy way both ingredients, cooking, composition and quantity. They also learn about changing habits, making realistic goals and using their motivation.', 'armGroupLabels': ['"Ned i vaegt" (NIV)']}, {'name': '"Verdens bedste kur" (VBK)', 'type': 'BEHAVIORAL', 'description': 'This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on "new nordic diet" and are a relative low-GI and high-protein diet. Focus is to learn to make new healthy dishes both ingredients, cooking and composition. They also learn about making realistic goals.', 'armGroupLabels': ['"Verdens bedste kur" (VBK)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500', 'city': 'Holstebro', 'country': 'Denmark', 'facility': 'Department of Nutrition, Regional Hospital West Jutland, Denmark', 'geoPoint': {'lat': 56.36009, 'lon': 8.61607}}], 'overallOfficials': [{'name': 'Allan S Christensen, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition, Regional Hospital West Jutland, Denmark'}, {'name': 'Lone Viggers, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition, Regional Hospital West Jutland, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospitalsenheden Vest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MHSc, RD', 'investigatorFullName': 'Allan Stubbe Christensen', 'investigatorAffiliation': 'Hospitalsenheden Vest'}}}}