Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-02 @ 9:37 PM
Study NCT ID:
NCT03840733
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-19
First Post:
2019-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2019-01-29', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Change', 'timeFrame': 'Baseline to 54 months', 'description': 'Change in body weight (kg)'}, {'measure': 'Weight Maintenance', 'timeFrame': '18 months to 54 months', 'description': 'Change in body weight (kg)'}, {'measure': 'Fat Mass Change', 'timeFrame': 'Baseline to 54 months', 'description': 'Change in Fat Mass (kg)'}, {'measure': 'Fat Free Mass Change', 'timeFrame': 'Baseline to 54 months', 'description': 'Change in Fat Free Mass (kg)'}, {'measure': 'Fat Mass Maintenance', 'timeFrame': '18 months to 54 months', 'description': 'Change in Fat Mass (kg)'}, {'measure': 'Fat Free Mass Maintenance', 'timeFrame': '18 months to 54 months', 'description': 'Change in Fat Free Mass (kg)'}], 'secondaryOutcomes': [{'measure': 'Change in Physical Activity Patterns', 'timeFrame': '0, 6, 12, 18, 24, 54 month', 'description': 'Physical activity patterns as measured by SenseWear armband (min/day)'}, {'measure': 'Physical Activity Patterns', 'timeFrame': '54 month', 'description': 'Physical activity patterns as measured by ActivPAL, Actigraph (min/day)'}, {'measure': 'Change in Sleep', 'timeFrame': '0, 6, 12, 18, 24, 54 month', 'description': 'Sleep patterns as measured by SenseWear armband (h/day)'}, {'measure': 'Sleep Patterns', 'timeFrame': '54 month', 'description': 'Sleep patterns as measured by Actiwatch-2, ActivPAL, Actigraph (h/day)'}, {'measure': 'Change in Energy Intake', 'timeFrame': '0, 6, 12, 18, 54 month', 'description': 'Energy Intake patterns as measured by 3 day food record (kcal/day'}, {'measure': 'Energy Intake Patterns', 'timeFrame': '54 month', 'description': 'Energy Intake patterns as measured by 24 hour food recall and meallogger smartphone application (kcal/day)'}, {'measure': 'Resting Metabolic Rate', 'timeFrame': '54 month', 'description': 'Resting metabolic rate as measured using indirect calorimetry (kcal/day)'}, {'measure': 'Total Daily Energy Expenditure', 'timeFrame': '54 month', 'description': 'Total Daily Energy Expenditure as measured by doubly labeled water (kcal/day)'}, {'measure': 'Physical Activity Energy Expenditure', 'timeFrame': '54 month', 'description': 'Physical Activity Energy Expenditure as measured by doubly labeled water (kcal/day)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'sleep', 'eating patterns', 'energy expenditure'], 'conditions': ['Obesity', 'Weight Change, Body']}, 'descriptionModule': {'briefSummary': 'This study is designed as an observational trial. The objective of this study is to follow-up with participants 3 years after completion of an 18-month comprehensive behavioral weight loss intervention. Outcomes of interest include change in body weight, body composition, physical activity, energy intake, and sleep. In addition, investigators will explore the associations between current physical activity, sleep, and energy intake patterns and body weight regulation.', 'detailedDescription': 'A total of 170 participants were initially enrolled in the comprehensive behavioral weight loss intervention.In this study, investigators will conduct a follow-up visit 3 years after the completion of the intervention. Only participants who completed the behavioral weight loss intervention will be enrolled in this study. Participants will undergo testing of body weight, body composition, physical activity patterns, energy intake patterns, sleep patterns, resting metabolic rate, and total daily energy expenditure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants previously enrolled in an 18-month behavioral weight loss intervention at the University of Colorado Anschutz Medical Campus. (NCT01985568)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous enrollment in standard behavioral weight loss intervention (NCT01985568 or NCT03411356)\n* Age 20-60 (This age range has been selected based upon the participants enrolled in the Parent Trial)\n* Capable and willing to give informed consent\n* Possess a smartphone to install and utilize the meal timing application\n* Capable and willing to wear the Actigraph, ActivPAL and Actiwatch-2 for 24 hours/day for 28 consecutive days\n* Willing to complete the Total Daily Energy Expenditure (TDEE) assessment which includes multiple urine collections and drinking stable water isotopes\n\nExclusion Criteria:\n\n* Being considered unsafe to participate as determined by the study physician (Dr. Catennaci)\n* New diagnosis of a medical condition (not observed in the Parent Trial) which may affect weight or energy metabolism (e.g. depression, CVD, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases)\n* Women who became pregnant after completing the Parent Trial\n* Current use or use within the last 6 months of prescription or over-the-counter medications known to affect appetite, weight, and sleep'}, 'identificationModule': {'nctId': 'NCT03840733', 'briefTitle': 'Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes', 'orgStudyIdInfo': {'id': '18-1319'}, 'secondaryIdInfos': [{'id': 'K01HL145023', 'link': 'https://reporter.nih.gov/quickSearch/K01HL145023', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants from NCT01985568 or NCT03411356', 'description': "All subjects who previously enrolled in the Parent Study's behavioral weight loss intervention (NCT01985568 or NCT03411356)."}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Seth A Creasy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}