Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-30 @ 12:00 PM
Study NCT ID:
NCT05093803
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2021-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Physical and Physiological Parameters Through the Use of a Mobile App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008064', 'term': 'Lipidoses'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT', 'timeFrame': '24 months', 'description': 'The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).'}, {'measure': 'HEIGHT', 'timeFrame': '24 months', 'description': 'The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).'}, {'measure': 'WAIST CIRCUMFERENCE', 'timeFrame': '24 months', 'description': 'The kinanthropometric evaluation is based on the methodology proposed for the restricted profile by the International Society for the Development of Kinanthropometry (ISAK). The material used to measure the perimeters will be a tape.'}, {'measure': 'HIP CIRCUMFERENCE', 'timeFrame': '24 months', 'description': 'The kinanthropometric evaluation is based on the methodology proposed for the restricted profile by the International Society for the Development of Kinanthropometry (ISAK). The material used to measure the perimeters will be a tape.'}, {'measure': 'CHOLESTEROL', 'timeFrame': '24 months', 'description': 'The blood cholesterol level is obtained through a blood test.'}, {'measure': 'TRIGLICERIDES', 'timeFrame': '24 months', 'description': 'The blood triglicerides level is obtained through a blood test.'}, {'measure': 'BLOOD PREASURE', 'timeFrame': '24 months', 'description': 'Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.'}, {'measure': 'FAT MASS', 'timeFrame': '24 months', 'description': 'Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.'}, {'measure': 'LEAN BODY MASS', 'timeFrame': '24 months', 'description': 'Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.'}, {'measure': 'VISCERAL FAT', 'timeFrame': '24 months', 'description': 'Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.'}, {'measure': 'HEART RATE', 'timeFrame': '24 months', 'description': 'Heart rate measurement is performed with an activity wristband.'}, {'measure': 'TROPONIN I', 'timeFrame': '24 months', 'description': 'The troponin I level is obtained through a blood test.'}, {'measure': 'BLOOD TROPONIN T LEVELS', 'timeFrame': '24 months', 'description': 'The troponin I level is obtained through a blood test.'}, {'measure': 'Broadband ultrasonic attenuation, BUA', 'timeFrame': '24 months', 'description': 'The measurement of the ultrasonic band attenuation (BUA) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.'}, {'measure': 'Ultrasonic wave propagation speed, SOS', 'timeFrame': '24 months', 'description': 'The measurement of ultrasonic wave propagation speed (SOS) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Diet, Healthy', 'Body Weight', 'Obesity', 'Cholesterol; Lipidosis', 'Machine Learning']}, 'descriptionModule': {'briefSummary': 'To investigate the health effects of a new mobile application (app) for prevention and personalized treatment in people with chronic cardiovascular pathologies associated with body composition.', 'detailedDescription': "Scientific evidence has shown that the adoption of the Mediterranean diet is a protective factor against the appearance of several types of cancer, cardiovascular diseases, aging and obesity due to the amount of nutrients with anti-cancer, anti-inflammatory and anti-obesity properties that jointly contribute to the maintenance of health status. The antitumor effects of the Mediterranean diet are mainly due to the combination of antioxidant elements, fiber and polyunsaturated fats. Therefore, this dietary pattern is essential as a preventive measure against the onset of cancer and other chronic diseases, but also to reduce health care costs.\n\nMonitoring physical activity should be considered as a central factor when addressing precision nutrition. Perform physical activity and exercise, as they are key components of energy expenditure and balance, in addition, structural changes occur in muscles, increase in the number of mitochondria in fiber, secretion of metabolically beneficial hormones with reversal of muscle insulin resistance and reduction of hepatic lipogenesis. Regardless of intensity, short-term exercise has been shown to improve adiposity and insulin sensitivity, which may help reduce metabolic risk. Boutcher et al. also demonstrated that intermittent aerobic and anaerobic exercise performed at an intensity \\>70% of maximal oxygen uptake significantly reduces ambulatory and office blood pressure in hypertensive individuals.\n\nThe development of this app aims, through self-management and visualizing the altered parameters and how they will evolve in your body in the short, medium and long term, to increase the population's commitment to these pathologies, in order to improve their health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women over 21 years of age\n\nExclusion Criteria:\n\n* Volunteers who do not have access to a smartphone.'}, 'identificationModule': {'nctId': 'NCT05093803', 'briefTitle': 'Improvement of Physical and Physiological Parameters Through the Use of a Mobile App', 'organization': {'class': 'OTHER', 'fullName': 'University of Alicante'}, 'officialTitle': 'Study of Physical and Physiological Changes Through the Use of a Mobile App That Promotes Healthy Habits', 'orgStudyIdInfo': {'id': 'UA-2021-03-27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL GROUP', 'description': 'Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.', 'interventionNames': ['Behavioral: CONTROL GROUP']}, {'type': 'EXPERIMENTAL', 'label': 'APP GROUP', 'description': 'Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity through the use of an app based on machine learning, so they have constant stimuli for the improvement of the parameters.', 'interventionNames': ['Behavioral: HEALTH APP GROUP']}], 'interventions': [{'name': 'CONTROL GROUP', 'type': 'BEHAVIORAL', 'description': 'Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.', 'armGroupLabels': ['CONTROL GROUP']}, {'name': 'HEALTH APP GROUP', 'type': 'BEHAVIORAL', 'otherNames': ['Nutritional and physical activity intervention through the use of an app.'], 'description': 'Use of a mobile application based on machine learning with the aim of improving health parameters and body composition.\n\nSpecific diet program and moderate physical activity, all guided and mediated by a mobile application. As well as the recording and monitoring of periodic evaluations of health indicators.', 'armGroupLabels': ['APP GROUP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03202', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Nutrición Selecta', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'overallOfficials': [{'name': 'Javier Sánchez Sánchez, Full', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'European University of Madrid'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alicante', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Prof. Dr. Alejandro Martínez-Rodríguez', 'investigatorAffiliation': 'University of Alicante'}}}}