Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-04 @ 3:53 PM
Study NCT ID:
NCT04192357
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2019-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2019-12-06', 'studyFirstSubmitQcDate': '2019-12-06', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of weight from baseline to the end of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Change in total fat mass', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of total fat mass, measured by bioimpedance analysis from baseline to the end of follow-up.'}, {'measure': 'Change in waist circumference', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of waist circumference from baseline to the end of follow-up.'}, {'measure': 'Change in body mass index', 'timeFrame': '18 months', 'description': 'Change in body mass index (calculated as change in kg/m2, weight in kilograms, height in meters) from baseline to the end of follow-up.'}, {'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change in systolic and diastolic blood pressure from baseline to the end of follow-up.'}, {'measure': 'Change in intestinal microbiota', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of intestinal microbiota from baseline to the end of follow-up.\n\nBacterial DNA will be extracted from fecal samples. 16SRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.'}, {'measure': 'Change in fasting plasma glucose concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of serum glucose concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in fasting plasma insulin concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of serum insulin concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in fasting plasma triglycerides concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of serum triglycerides concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in fasting plasma low density lipoprotein (LDL) concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of serum low density lipoprotein (LDL) concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in fasting plasma high density lipoprotein (HDL) concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of serum high density lipoprotein (HDL) concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in fasting plasma glycated hemoglobin A1c (HbA1c) concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of serum glycated hemoglobin A1c (HbA1c) concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in alanine aminotransferase (ALT) concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of alanine aminotransferase (ALT) concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in aspartate aminotransferase (AST) concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of aspartate aminotransferase (AST) concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in gamma-glutamyl transpeptidase (GGT) concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of gamma-glutamyl transpeptidase (GGT) concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in HOMA-IR', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in HOMA-IR (homeostasis model assessment of insulin resistance) from baseline to the end of follow-up, calculated using the formula: fasting plasma glucose (mmol/L) x Fasting insulin (mIU/L)/22.5.'}, {'measure': 'Change in creatinine concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of creatinine concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in vitamin D concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of vitamin D concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in high-sensitivity C-reactive protein (hs-CRP) concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of high-sensitivity C-reactive protein (hs-CRP) concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in sodium concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of sodium concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in potassium concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of potassium concentrations from baseline to the end of follow-up.'}, {'measure': 'Change in magnesium concentrations', 'timeFrame': '18 months', 'description': 'Difference between the intervention and control group in the change of magnesium concentrations from baseline to the end of follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '40732984', 'type': 'DERIVED', 'citation': 'Pereira V, Cuevas-Sierra A, de la O V, Salvado R, Barreiros-Mota I, Castela I, Camelo A, Brandao I, Santo CE, Faria A, Calhau C, Silvestre MP, Moreira-Rosario A. Gut Microbiota Shifts After a Weight Loss Program in Adults with Obesity: The WLM3P Study. Nutrients. 2025 Jul 18;17(14):2360. doi: 10.3390/nu17142360.'}, {'pmid': '38844671', 'type': 'DERIVED', 'citation': 'Pereira V, Barreiros-Mota I, Cortez F, Castela I, Teixeira D, Calhau C, Camila Dias C, Moreira-Rosario A, Silvestre MP. A randomized controlled trial of a weight loss maintenance program in adults with obesity: the WLM3P study. Eur J Clin Nutr. 2024 Aug;78(8):694-702. doi: 10.1038/s41430-024-01454-4. Epub 2024 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of a Weight Loss Maintenance 3 Phases Program (WLM3P) in maintaining long-term weight loss (at least 5% of initial body weight loss at 18 months), compared to a standard low carbohydrate diet (LCD) in adults with obesity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged 18 to 65 years\n* BMI ≥ 30 kg/m2 and ≤ 39.9 kg/m2\n* Interested in being enrolled in a weight loss program\n* Available to comply with study protocol and sign informed consent\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding or planning to become pregnant within the study period.\n* Subjects with chronic inflammatory bowel disease (clinical history of Crohn's disease, ulcerative colitis, irritable colon and diverticulitis)\n* Subjects with hormonal or thyroid pathology (hyper and hypothyroidism where TSH is not within normal range)\n* Subjects with renal impairment\n* Subjects with chronic liver disease other than non-alcoholic hepatic steatosis\n* Subjects with autoimmune diseases and/or chronic use of corticosteroids.\n* Use of weight loss medications/other nutritional supplements\n* Subjects with psychiatric or neurological illness\n* Subjects sensitive to any component of supplements\n* Subjects with surgery or hospitalization in the last 30 days\n* Subjects prescribed with 5 or more drugs\n* Previous attempt to lose weight in the last month and/or weight loss of more than 10kg in the 3 months prior to the start of the study\n* Subjects with excessive alcohol consumption (self-reported: drinking more than 3 glasses of wine/day - or equivalent)\n* Subjects with history of drug, alcohol or other substances abuse.\n* Eating behavior disorders\n* Pacemaker carrier\n* Urinary incontinence\n* Vegetarians or vegans\n* Subjects underwent bariatric surgery\n* Type 1 or type 2 diabetes mellitus\n* Altered blood clotting\n* Severe heart failure"}, 'identificationModule': {'nctId': 'NCT04192357', 'acronym': 'WLM3P', 'briefTitle': 'A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Porto'}, 'officialTitle': 'A Randomised Controlled Trial of a Weight Loss Maintenance Program for Adults With Obesity: The WLM3P Study', 'orgStudyIdInfo': {'id': 'WLM3P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WLM3P', 'description': 'Participants will receive the M3F program. The M3F program is divided into three phases, being the first two of weight loss and the third phase of weight maintenance.', 'interventionNames': ['Behavioral: WLM3P']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-carb diet', 'description': 'Participants will receive the low-carb diet program. The low-carb diet program is divided into two phases, being the first of weight loss which follows a low carb diet, and a second phase of weight maintenance.', 'interventionNames': ['Behavioral: Low-carb diet']}], 'interventions': [{'name': 'WLM3P', 'type': 'BEHAVIORAL', 'description': '18 months behavioral weight loss program divided into three phases (first and second phase of weight loss, during 1 month and 5 months, respectively; and a third phase of weight maintenance, during 12 months).', 'armGroupLabels': ['WLM3P']}, {'name': 'Low-carb diet', 'type': 'BEHAVIORAL', 'description': '18 months behavioral weight loss program divided in two phases (first of weight loss during 6 months and a second phase of weight maintenance during 12 months).', 'armGroupLabels': ['Low-carb diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1169-056', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'NOVA Medical School, NOVA University of Lisbon', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Conceição Calhau, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CINTESIS, NOVA Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Porto', 'class': 'OTHER'}, 'collaborators': [{'name': 'NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa', 'class': 'UNKNOWN'}, {'name': 'CINTESIS@RISE, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}