Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-29 @ 6:09 PM
Study NCT ID:
NCT02413866
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2015-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Outlooks by Restriction of Diet and Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012890', 'term': 'Sleep'}], 'ancestors': [{'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2015-04-07', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'body composition measured via DXA scans', 'timeFrame': '4 months', 'description': 'Body composition will be measured via DXA scans prior to intervention and post intervention to compare losses in lean body mass and fat mass.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['body composition', 'anthropometry'], 'conditions': ['Weight']}, 'referencesModule': {'references': [{'pmid': '33644759', 'type': 'DERIVED', 'citation': 'Sparks JR, Porter RR, Youngstedt SD, Bowyer KP, Durstine JL, Wang X. Effects of moderate sleep restriction during 8-week calorie restriction on lipoprotein particles and glucose metabolism. Sleep Adv. 2021 Jan 28;1(1):zpab001. doi: 10.1093/sleepadvances/zpab001. eCollection 2020.'}, {'pmid': '29438540', 'type': 'DERIVED', 'citation': 'Wang X, Sparks JR, Bowyer KP, Youngstedt SD. Influence of sleep restriction on weight loss outcomes associated with caloric restriction. Sleep. 2018 May 1;41(5):10.1093/sleep/zsy027. doi: 10.1093/sleep/zsy027.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether chronic moderate sleep restriction effects the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are participating in a dietary weight loss program.', 'detailedDescription': 'Participants will be randomly assigned to an 8-week program of either restricted diet alone, or restricted diet with restricted sleep for 5 days a week. The total expected duration of participation is approximately 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 35-55 years,\n* BMI between 30-35 kg/meters squared,\n* total sleep time between 6.5-8 hours\n\nExclusion Criteria:\n\n* work requiring changing schedule,\n* use of sleep aids or sleep medication'}, 'identificationModule': {'nctId': 'NCT02413866', 'acronym': 'WORDS', 'briefTitle': 'Weight Outlooks by Restriction of Diet and Sleep', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Weight Outlooks by Restriction of Diet and Sleep', 'orgStudyIdInfo': {'id': 'Pro00036519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calorie Restriction Only', 'description': 'Participants in this group will be decreasing their caloric intake to approximately 95% of their resting metabolic rate. We will provide one meal for 4 days of the week, and participants will be required to keep an accurate dietary record of all food and drink. Participants assigned to this group will be instructed to keep a fixed sleep schedule based on their own sleep/napping habits.', 'interventionNames': ['Behavioral: Calorie restriction only']}, {'type': 'EXPERIMENTAL', 'label': 'Sleep & Calorie Restriction', 'description': 'Participants in this group will decrease their caloric intake to approximately 95% of their resting metabolic rate in addition to reducing their total time in bed by 90 minutes 5 days a week.', 'interventionNames': ['Behavioral: Sleep & calorie restriction']}], 'interventions': [{'name': 'Calorie restriction only', 'type': 'BEHAVIORAL', 'description': 'Participants randomly assigned to this group will be instructed to reduce their daily energy intake to 95% of their resting metabolic rate.', 'armGroupLabels': ['Calorie Restriction Only']}, {'name': 'Sleep & calorie restriction', 'type': 'BEHAVIORAL', 'description': 'Participants randomly assigned to this group will be instructed to reduce their total time in bed by 90 minutes 5 days a week, in addition to restricting their dietary intake to approximately 95% of their resting metabolic rate.', 'armGroupLabels': ['Sleep & Calorie Restriction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Xuewen Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Xuewen Wang', 'investigatorAffiliation': 'University of South Carolina'}}}}