Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-03-13 @ 6:55 AM
Study NCT ID:
NCT03696966
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2018-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KU Alternate Meal Energy Level Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-18', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight (lbs, % change from baseline)', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)'}, {'measure': 'Body composition', 'timeFrame': 'Change from baseline to 24 weeks', 'description': 'Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Program adherence', 'timeFrame': 'weekly through study completion (24 weeks)', 'description': 'Compliance to intervention protocol; adherence = (# attained / # expected)\\*100'}, {'measure': 'Nutrition-related quality of life', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.'}, {'measure': 'Dietary restraint', 'timeFrame': 'baseline, week 12, week 24', 'description': 'Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['weight management', 'obesity', 'very-low calorie diet', 'intermittent diet'], 'conditions': ['Obesity', 'Weight Loss']}, 'descriptionModule': {'briefSummary': 'Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.', 'detailedDescription': 'The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.\n\nEach intervention includes 3 months of weight loss and 3 months of weight maintenance.\n\nGroup 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)\n\nGroup 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 21-65 years.\n2. BMI 25-35. Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI \\>35 may require more aggressive weight management strategies.\n3. Clearance for participation from their PCP.\n\nExclusion Criteria:\n\n1. Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.\n2. Participation in a regular exercise program (i.e., \\> 500 kcal/wk. of planned activity as estimated by questionnaire \\[34\\].\n3. Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire\n4. Unwilling to be randomized to one of two diet strategies for weight loss.\n5. Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.\n6. Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.\n7. Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater \\[35\\]. This score indicates the need for counseling outside the scope of this study.\n8. Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.\n9. Medications known to significantly influence weight.\n10. Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)\n11. Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).\n12. If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year."}, 'identificationModule': {'nctId': 'NCT03696966', 'acronym': 'KAMEL', 'briefTitle': 'KU Alternate Meal Energy Level Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'KU Alternate Meal Energy Level Study', 'orgStudyIdInfo': {'id': 'IRB_STUDY00141322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Calorie Restriction', 'description': 'Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals', 'interventionNames': ['Dietary Supplement: Portion-Controlled Meals', 'Behavioral: Low-Calorie Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Intermittent Very-Low Calorie Diet', 'description': 'Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days', 'interventionNames': ['Dietary Supplement: Portion-Controlled Meals', 'Behavioral: Intermittent Very-Low Calorie Diet']}], 'interventions': [{'name': 'Portion-Controlled Meals', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Increase dietary structure using portion-controlled meals (PCM)', 'armGroupLabels': ['Continuous Calorie Restriction', 'Intermittent Very-Low Calorie Diet']}, {'name': 'Low-Calorie Diet', 'type': 'BEHAVIORAL', 'description': 'Restrict calorie intake daily', 'armGroupLabels': ['Continuous Calorie Restriction']}, {'name': 'Intermittent Very-Low Calorie Diet', 'type': 'BEHAVIORAL', 'otherNames': ['Intermittent Fasting'], 'description': 'Severely restrict calorie intake intermittently', 'armGroupLabels': ['Intermittent Very-Low Calorie Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Debra Sullivan, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Debra K. Sullivan, PhD, RD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}