Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-09 @ 2:45 AM
Study NCT ID:
NCT01997060
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2013-11-21', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to physical activity', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'International Physical Activity Questionaire (IPAQ) to determine adherence to physical activity. Furthermore we will use diary and ActiHeart (accelerometer).'}, {'measure': 'Adherence to healthy diet', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Questionnaire (24hrs dietary recall) and diary to determine adherence to a healthy diet.'}, {'measure': 'Mitochondria respiration and efficiency', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Mitochondria respiration and efficiency is measured by Oreboros Oxygraph.'}, {'measure': 'Blood and plasma substrates, hormones and metabolites', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'HbA1c, insulin, leptin, glucose, adiponectin, thyroid stimulating hormone (TSH), ghrelin'}, {'measure': 'Muscle lipid composition', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Muscle lipid composition will be analysed using a lipidomics approach.'}, {'measure': 'Expression of muscle lipases', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Western blot analysis will be applied to analyse expression of muscle lipases; hormone sensitive lipase (HSL), adipose triglyceride lipase (ATGL) and lipoprotein lipase (LPL) as well as muscle PAT proteins; PLIN 2 (ADRP), PLIN 3 (TIP47) and PLIN 5 (OXPAT)'}, {'measure': 'Intramuscular lipid droplet content and size, glycogen content and ceramide content and location', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Intramuscular lipid droplet content and size, glycogen content and ceramide content and location will be quantified by immunohistochemical staining of serial cryo-sections of muscle tissue samples that are visualized by confocal microscopy'}, {'measure': 'Adipose tissue macrophage inflammation and cytokine production', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months'}, {'measure': 'Motivation for lifestyle changes and sociological factors involved', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Questionnaires'}], 'primaryOutcomes': [{'measure': 'Total body weight', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months'}], 'secondaryOutcomes': [{'measure': 'Maximal fat oxidation during exercise', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Respiratory Exchange Ratio (RER) is measured and maximal fat oxidation is calculated.'}, {'measure': 'Anthropometry', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months', 'description': 'Body composition measured by dual x-ray absorptiometry or bio-impedance, height, weight, waist circumference.'}, {'measure': 'Maximal Oxygen Consumption', 'timeFrame': 'Changes from baseline at 3, 6, 15 and 39 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lifestyle intervention', 'Body weight', 'Body composition', 'Weight loss maintenance', 'Physical activity'], 'conditions': ['Obesity', 'Overweight']}, 'referencesModule': {'references': [{'pmid': '24090083', 'type': 'BACKGROUND', 'citation': 'Karlsen TI, Sohagen M, Hjelmesaeth J. Predictors of weight loss after an intensive lifestyle intervention program in obese patients: a 1-year prospective cohort study. Health Qual Life Outcomes. 2013 Oct 3;11:165. doi: 10.1186/1477-7525-11-165.'}, {'pmid': '23801526', 'type': 'BACKGROUND', 'citation': 'McCormack SE, McCarthy MA, Harrington SG, Farilla L, Hrovat MI, Systrom DM, Thomas BJ, Torriani M, McInnis K, Grinspoon SK, Fleischman A. Effects of exercise and lifestyle modification on fitness, insulin resistance, skeletal muscle oxidative phosphorylation and intramyocellular lipid content in obese children and adolescents. Pediatr Obes. 2014 Aug;9(4):281-91. doi: 10.1111/j.2047-6310.2013.00180.x. Epub 2013 Jun 25.'}, {'pmid': '23710347', 'type': 'BACKGROUND', 'citation': 'Danielsen KK, Svendsen M, Maehlum S, Sundgot-Borgen J. Changes in body composition, cardiovascular disease risk factors, and eating behavior after an intensive lifestyle intervention with high volume of physical activity in severely obese subjects: a prospective clinical controlled trial. J Obes. 2013;2013:325464. doi: 10.1155/2013/325464. Epub 2013 Apr 22.'}, {'pmid': '16352667', 'type': 'BACKGROUND', 'citation': 'Bruun JM, Helge JW, Richelsen B, Stallknecht B. Diet and exercise reduce low-grade inflammation and macrophage infiltration in adipose tissue but not in skeletal muscle in severely obese subjects. Am J Physiol Endocrinol Metab. 2006 May;290(5):E961-7. doi: 10.1152/ajpendo.00506.2005. Epub 2005 Dec 13.'}, {'pmid': '16403343', 'type': 'BACKGROUND', 'citation': 'Pedersen JO, Zimmermann E, Stallknecht BM, Bruun JM, Kroustrup JP, Larsen JF, Helge JW. [Lifestyle intervention in the treatment of severe obesity]. Ugeskr Laeger. 2006 Jan 9;168(2):167-72. Danish.'}, {'pmid': '17893261', 'type': 'BACKGROUND', 'citation': 'Bruun JM, Stallknecht B, Helge JW, Richelsen B. Interleukin-18 in plasma and adipose tissue: effects of obesity, insulin resistance, and weight loss. Eur J Endocrinol. 2007 Oct;157(4):465-71. doi: 10.1530/EJE-07-0206.'}, {'pmid': '17299115', 'type': 'BACKGROUND', 'citation': 'Christiansen T, Bruun JM, Madsen EL, Richelsen B. Weight loss maintenance in severely obese adults after an intensive lifestyle intervention: 2- to 4-year follow-up. Obesity (Silver Spring). 2007 Feb;15(2):413-20. doi: 10.1038/oby.2007.530.'}, {'pmid': '30024231', 'type': 'DERIVED', 'citation': 'Elsborg P, Elbe AM. Exercise-specific volition and motivation for weight loss maintenance following an intensive lifestyle intervention. Health Psychol. 2018 Aug;37(8):759-766. doi: 10.1037/hea0000636.'}]}, 'descriptionModule': {'briefSummary': 'In Denmark and the western world, there is an increasing prevalence of obesity probably due to a combination of inadequate daily physical activity and a high energy intake. One approach to achieve weight loss and change life style is to participate in an intensive supervised prolonged life style modification course. The immediate effect is often positive, but over time the overall effect is limited as the majority will not maintain weight loss and a changed life style.\n\nThe purpose of this study is therefore to characterize the physiological factors that determine/influence the capacity to maintain weight loss and a healthy lifestyle after a prolonged lifestyle intervention.\n\nWe have the following research questions:\n\n1. Are there physiological traits and characteristics that mediate better adherence to lifestyle changes and weight loss?\n2. Does the adaptation in muscle oxidative capacity after lifestyle intervention predict success in maintaining weight loss and lifestyle changes 3, 12 and 39 months after intervention?\n3. How does gender and age influence the capacity to maintain the lifestyle induced adaptation in muscle and adipose tissue and maintaining weight loss?\n\nThe study design is a longitudinal intervention and will be based on a lifestyle intervention, as it is practiced in a real life setting at Ubberup folk high school.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants at Ubberup Folk High School\n\nExclusion Criteria:\n\n* Previous Gastric Bypass Surgery or Gastric Banding\n* BMI\\<25'}, 'identificationModule': {'nctId': 'NCT01997060', 'briefTitle': 'Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Physiological Factors That Influence Maintenance of Lifestyle Changes and Weight Loss - a Longitudinal Study', 'orgStudyIdInfo': {'id': 'UBBERUP2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intensive Lifestyle Intervention', 'description': 'Intensive Lifestyle Intervention at Ubberup Folk High School for 10-14 weeks. Daily exercise for 1-3hrs. Calorie restriction (\\~-700KCal/day). Education within nutrition, exercise and healthy living in general.', 'interventionNames': ['Behavioral: Intensive Lifestyle Intervention']}], 'interventions': [{'name': 'Intensive Lifestyle Intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intensive Lifestyle Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University of Copenhagen, Department of Biomedical Sciences', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Jørn W Helge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen, Department of Biomedical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ubberup Folk High School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jørn Wulff Helge', 'investigatorAffiliation': 'University of Copenhagen'}}}}