Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT02893150
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2016-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness Intervention for Overweight Primary Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cholesterol and fractions, triglycerides', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected reduction in cholesterol and fractions level and triglycerides'}, {'measure': 'C-reactive protein', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected reduction in PCR level'}, {'measure': 'waist perimeter', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected reduction in waist perimeter'}, {'measure': 'food consumption', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected improve quality of food consumption (questionaire)'}, {'measure': 'Body fat', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected to reduce the body fat percentage (bioimpedance)'}, {'measure': 'Basal metabolism rate', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected to increase the basal metabolic rate-calorimeter'}, {'measure': 'Physical Activity', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected to increase the physical activity (Brief Physical Activity Assessment Tool'}, {'measure': 'Risk of eating Disorder', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected to reduce the risk score of eating disorder (questionaire EAT 26)'}], 'primaryOutcomes': [{'measure': 'Feeding Behaviour', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected the improvement of the feeding behaviour measured by Dutch Eating Behaviour Questionaire (DEBQ) in total score and in 3 subscales: Restriction , External Intake and Emotional Intake and with the scale EAT 26'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected the improvement of Fasting blood glucose level'}, {'measure': 'levels of mindfulness,', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It expected to increase the levels of Mindfulness-psychometric scale'}, {'measure': 'Levels of depression', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It expected to reduce the levels of Depression-psychometric scale'}, {'measure': 'Levels of anxiety', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It expected to reduce the levels of anxiety -psychometric scale and serum cortisol'}, {'measure': 'Serum cortisol', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It expected to reduce the levels of cortisol'}, {'measure': 'Self-compassion', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It expected to improve the levels of self-compassion scale'}, {'measure': 'HBA1C (glycated hemoglobina)', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected the improvement of glycated hemoglobina level'}, {'measure': 'Insulin', 'timeFrame': 'Up to 3-month of follow-up', 'description': 'It is expected reduction in insulin level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindful Eating', 'Overweight', 'Primary Care', 'Randomized Clinical Trial'], 'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Brasil. 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São Paulo, 2011. 20(1): p.95-103.'}, {'type': 'RESULT', 'citation': 'Sociedade Brasileira de Endocrinologia e Metabologia- Projeto Diretrizes - Obesidade: Terapia Cognitivo-Comportamental, 2005 10p.'}, {'pmid': '35138182', 'type': 'DERIVED', 'citation': 'Salvo V, Schveitzer MC, Sanudo A, Favarato ML, Demarzo M. Exploring perceptions about Mindfulness and Mindful Eating Programs for low-income women with overweight in primary health care. Nutr Health. 2023 Jun;29(2):319-329. doi: 10.1177/02601060221075537. Epub 2022 Feb 9.'}, {'pmid': '29751819', 'type': 'DERIVED', 'citation': "Salvo V, Kristeller J, Montero Marin J, Sanudo A, Lourenco BH, Schveitzer MC, D'Almeida V, Morillo H, Gimeno SGA, Garcia-Campayo J, Demarzo M. Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial. Trials. 2018 May 11;19(1):277. doi: 10.1186/s13063-018-2639-y."}]}, 'descriptionModule': {'briefSummary': 'Mindfulness has been applied in the United States and Europe to improve both physical and psychological health, however, it is still poorly studied in Brazil. Mindfulness, or its lack, may also have particular relevance to obesity and eating disorders, reducing the episodes of "binge eating", which are partly responsible for weight regain for many people, and improving the eating behavior in order to promote awareness of emotional states which distort the physiological signals generated by the process. The hypothesis is that Mindfulness-based Interventions (MBI) as well as specific programmes focused on conscious eating, as Mindfulness Based Eating Awareness Training (MB-EAT) can, in short time, and in a sustainable fashion, improve biochemical, psychometric and anthropometric parameters in primary care patients with overweight.', 'detailedDescription': 'A randomized-controlled trial will be conducted to compare treatment-as-usual (TAU) in Primary Care combined a generic MBI (with 8 sessions) developed by our research group, called "Mindfulness-Based Health Promotion" (MBHP) program versus TAU plus MB-EAT. It will be included women aged ≥18 and \\< 60, literate , with a BMI (body mass index) ≥ 25 kg/m2. The primary outcome is the improvement of the eating behaviour measured by DEBQ. Secondary outcomes are: It is expected improvement of nutritional status (reduction of body weight by at least 5% of the weight) along the intervention, as well as maintenance of this (without weight regain) which could lead to the prevention of multiple morbidities related to excess body weight. Will be assessed the levels of Mindfulness, stress, anxiety (psychometric scale and serum cortisol) and self-compassion. There will be performed basal (baseline), at post-intervention, 3 and 6 months follow-up measurements. The control group will receive the intervention that has been shown to be more effective at the end of the study (MBHP or MB-EAT).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged 18-59 years old, literate;\n* Primary Care patients who have the body mass index (BMI) ≥25kgm2 and \\< 40kg/m2\n* People who have an interest in the objectives of this study and consented to be randomized to one of three arms.\n* Those who have participated in 75% of sessions or only two absences in the program\n\nExclusion Criteria:\n\n* those who are under pharmacological treatment for overweight;\n* pregnant women;\n* those who have problems with substance use (drugs and alcohol);\n* untreated hypothyroidism or hyperthyroidism;\n* those who are in acute phase of depression (less than 6 months in depression); schizophrenia or psychotic disorders or who are using drugs that cause cognitive attentional and concentration losses (such as powerful anti-anxiety drugs);\n* current practitioners of Mindfulness, meditation, yoga, or the like, in the last 6 months (with formal practice at least once a week);\n* those who have undergone any type of Bariatric Surgery.'}, 'identificationModule': {'nctId': 'NCT02893150', 'acronym': 'MindEat', 'briefTitle': 'Mindfulness Intervention for Overweight Primary Care Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centro Mente Aberta de Mindfulness'}, 'officialTitle': 'Mindfulness as a Complementary Intervention for Overweight Primary Care Patients: Study Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Mindful Eating'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAU (treatment as usual)', 'description': 'The Treatment as Usual (TAU) will be considered as following: 1) In the cases of individuals presenting overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, primary care teams propose the improvement of the life style (more physically active, and with a better eating behaviour) in order to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²). 2) For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities (psycho-education), it is evaluated the need for individual dietary prescription by a nutritionist.', 'interventionNames': ['Behavioral: TAU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU+MBHP', 'description': 'The Mindfulness-based Health Promotion (MBHP) developed by our research group (generic protocol) will be adapted from the Mindfulness-based Stress Reduction program (MBSR), It is based on the original model developed by Jon Kabat-Zinn and colleagues (MBSR), and subsequently adapted by our research group in order to fit it better into the context and needs of Primary Care (PC) and national and local Health Systems\\], which has been applied by the Center "Mente Aberta" in Brazil (www.mindfulnessbrasil.com), and by the University of Zaragoza, in Spain (www.webmindfulness.com). One of the sessions (the sixth one) is developed in silence, with the goal of deepening the mindfulness practice.', 'interventionNames': ['Behavioral: TAU+MBHP']}, {'type': 'EXPERIMENTAL', 'label': 'TAU+MB-EAT', 'description': 'The Mindfulness-based Eating Awareness (MB-EAT) protocol consists in ten weekly sessions of 2,5 hour to improve compulsive eating, and to promote conscious eating.', 'interventionNames': ['Behavioral: TAU+MB-EAT']}], 'interventions': [{'name': 'TAU', 'type': 'BEHAVIORAL', 'description': 'TAU (Treatment as Usual), individuals presenting with overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, teams of primary care (PC) organized care plans to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²).\n\nFor those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities, evaluates the need for individual dietary prescription by the nutritionist. This decision is discussed among the team of PC and Matrix support team', 'armGroupLabels': ['TAU (treatment as usual)']}, {'name': 'TAU+MBHP', 'type': 'BEHAVIORAL', 'description': 'TAU (Treatment as Usual) + MBHP. We used a general (general vulnerability, not specific) mindfulness-based intervention (MBI) developed by our research group, an 8-week-group-based MBI called "Mindfulness-Based Health Promotion" (MBHP) program . It is based on the original model developed by Jon Kabat-Zinn and colleagues (MBSR), and subsequently adapted by our research group in order to fit it better into the context and needs of Primary Care (PC) and national and local Health Systems, which has been applied by the Center "Mente Aberta" in Brazil (www.mindfulnessbrasil.com), and by the University of Zaragoza, in Spain (www.webmindfulness.com). One of the sessions (the sixth one) is developed in silence, with the goal of deepening the mindfulness practice; more feasible to be implement in health services and facilities', 'armGroupLabels': ['TAU+MBHP']}, {'name': 'TAU+MB-EAT', 'type': 'BEHAVIORAL', 'description': 'TAU (Treatment as Usual) + MB-EAT (mindfulness-based eating awareness training). Adapted from the MBSR, Mindfulness-based Eating Awareness Training (MB-EAT) or awareness training. This program was specially developed for the compulsive eating disorders and related problems\\[47\\]. In addition the four main techniques of meditation mentioned in the MBHP program includes modifications to these basic techniques, and include experimentation with different flavors, sweet and savory foods, etc. Has 10 weekly sessions of 2,5h', 'armGroupLabels': ['TAU+MB-EAT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro Mente Aberta de Mindfulness e Promoção de Saúde', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Marcelo Demarzo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNIFESP - Federal University of Sao Paulo, Brazil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Mente Aberta de Mindfulness', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Phd.', 'investigatorFullName': 'Marcelo Demarzo, MD, PhD', 'investigatorAffiliation': 'Centro Mente Aberta de Mindfulness'}}}}