Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 1:50 AM
Study NCT ID:
NCT05505305
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-restricted Eating and Interval Training With Digital Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adherence to high-intensity interval training', 'timeFrame': 'Seven weeks', 'description': 'Number of completed exercise sessions out of those prescribed, in percentage'}, {'measure': 'Compliance to high-intensity interval training', 'timeFrame': 'Seven weeks', 'description': 'Exercise intensity measured with pulse sensor. Heart rate percentage of individual heart rate maximum.'}, {'measure': 'Adherence to time-restricted eating', 'timeFrame': 'Seven weeks', 'description': 'Average number of days per week a daily eating window of 10 hours or less was achieved'}, {'measure': 'Compliance to time-restricted eating', 'timeFrame': 'Seven weeks', 'description': 'Average daily eating window, self-reported in hours/day'}, {'measure': 'Perception of intervention and digital follow-up', 'timeFrame': 'After seven weeks of intervention', 'description': 'Qualitative questionnaire after seven weeks of intervention'}, {'measure': 'Sex differences', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Sub-analyses of sex differences in the effectiveness of the intervention'}], 'primaryOutcomes': [{'measure': 'Total fat mass', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Change in total fat mass measured with bioelectrical impedance analysis'}], 'secondaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Fasting concentration of plasma glucose'}, {'measure': 'Insulin', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Fasting concentration of plasma insulin C-peptide'}, {'measure': 'Average glucose levels', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Glycated hemoglobin (HbA1c)'}, {'measure': 'Blood Cholesterol', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Total fasting cholesterol in blood'}, {'measure': 'HDL-cholesterol in blood', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Fasting high-density lipoprotein-cholesterol in blood'}, {'measure': 'LDL-cholesterol in blood', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Fasting low-density lipoprotein-cholesterol in blood'}, {'measure': 'Triglycerides in blood', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Fasting triglycerides in blood'}, {'measure': 'Insulin sensitivity', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Homeostatic model assessment for insulin resistance (HOMA-IR): 1.5 + fasting plasma glucose (mmol/L) × fasting plasma insulin C-peptide (pmol/L) / 2800'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Peak oxygen uptake at a maximum effort exercise test, measured in mL/min/kg and L/min'}, {'measure': 'Body mass', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'In kg, estimated with bioelectrical impedance analysis'}, {'measure': 'Body fat-free mass', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'In kg, estimated with bioelectrical impedance analysis'}, {'measure': 'Visceral fat area', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'In cm², estimated with bioelectrical impedance analysis'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Average of three measurements during rest in seated position, in mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Average of three measurements during rest in seated position, in mmHg'}, {'measure': 'Resting heart rate', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'Average of three measurements during rest in sitting position, in beats/min'}, {'measure': 'Physical activity level', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'International Physical Activity Questionnaire, categorical score'}, {'measure': 'Self-reported physical activity', 'timeFrame': '7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.', 'description': 'Self-reported duration and intensity of daily physical activity during baseline week, first week of intervention, and last week of intervention, in metabolic equivalent of task (MET)/week'}, {'measure': 'Diet intake', 'timeFrame': '7 days at baseline, 7 days at start of intervention, 7 days at end of intervention.', 'description': 'Online food diary during baseline week, first week of intervention, and last week of intervention, in kilojoules (kJ)/week'}, {'measure': 'Sleep quality', 'timeFrame': 'From baseline to after 7 weeks of intervention', 'description': 'The Pittsburgh Sleep Quality Index questionnaire'}, {'measure': 'Sleep duration', 'timeFrame': '7 days at baseline, 7 days at start of intervention, 7 days at end of intervention', 'description': 'Self-reported hours of sleep per night during baseline week, first week of intervention, and last week of intervention, average hours/night'}, {'measure': 'Appetite', 'timeFrame': '7 days at baseline, 7 days at start of intervention, 7 days at end of intervention', 'description': 'Self-reported ratings of hunger/satiety on visual analogue scale upon waking and before bedtime during baseline week, first week of intervention, and last week of intervention, average hours/night'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['time-restricted eating', 'high-intensity interval training', 'exercise', 'diet', 'body composition'], 'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': "This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). Before and after the intervention, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index ≥ 27 kg/m²\n* Able to walk or ride a bike \\> 60 min\n\nExclusion Criteria:\n\n* On-going pregnancy\n* Lactation within 24 weeks of study commencement\n* High-intensity exercise ≥ 1/week\n* Habitual eating window ≤12 hours/day\n* Taking hypertension, glucose-, or lipid-lowering drugs\n* Body mass variation ≥ 4 kg three months prior to study commencement\n* Known diabetes mellitus (type 1 or 2) or cardiovascular disease\n* Working night shifts'}, 'identificationModule': {'nctId': 'NCT05505305', 'acronym': 'TREHIIT-DFU', 'briefTitle': 'Time-restricted Eating and Interval Training With Digital Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effects of Time-restricted Eating and Interval Training With Digital Follow-up: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '479143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time-restricted eating and high-intensity interval training', 'description': 'Seven weeks of time-restricted eating and high-intensity interval training with digital follow-up.', 'interventionNames': ['Behavioral: Time-restricted eating and high-intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention nor digital follow-up for seven weeks.'}], 'interventions': [{'name': 'Time-restricted eating and high-intensity interval training', 'type': 'BEHAVIORAL', 'description': 'Maximal daily eating window of 10 hours and high-intensity interval training (three weekly, unsupervised, aerobic exercise sessions performed at \\> 90 % heart rate maximum). Each exercise session will last for 33-38 minutes. Participants will receive digital follow-up once weekly. The intervention period will be seven weeks,', 'armGroupLabels': ['Time-restricted eating and high-intensity interval training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Department of circulation and medical imaging, NTNU', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Øivind Rognmo, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology, Trondheim, Norway'}, {'name': 'Trine Moholdt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology, Trondheim, Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}