Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-04 @ 8:47 PM
Study NCT ID:
NCT01878994
Status:
UNKNOWN
Last Update Posted:
2013-06-17
First Post:
2013-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-13', 'studyFirstSubmitDate': '2013-06-11', 'studyFirstSubmitQcDate': '2013-06-13', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Body mass index z score (BMIz)', 'timeFrame': '4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention', 'description': 'Weight is measured to the nearest of 0.1 kg using an electronic scale and height (Ht) to the nearest of 0.1 cm with a stadiometer, in lightly dressed and without shoes. The BMIz is calculated according z score of BMI adjusted by age and gender (IOTF).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Physical activity habits', 'timeFrame': '4 times: at baseline, at the end of the intervention (8 months later of the baseline), 6 and 12 months post intervention', 'description': 'To measure physical activity will be used an Actigraph accelerometers (GT3X+ models), it will be wear by participants during all day for seven consecutive days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Children', 'Behaviour', 'Physical Activity', 'Nutrition'], 'conditions': ['Overweight', 'Obesity', 'Children']}, 'referencesModule': {'references': [{'pmid': '26658988', 'type': 'DERIVED', 'citation': 'Serra-Paya N, Ensenyat A, Castro-Vinuales I, Real J, Sinfreu-Bergues X, Zapata A, Mur JM, Galindo-Ortego G, Sole-Mir E, Teixido C. Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial. PLoS One. 2015 Dec 14;10(12):e0144502. doi: 10.1371/journal.pone.0144502. eCollection 2015.'}, {'pmid': '24153001', 'type': 'DERIVED', 'citation': 'Serra-Paya N, Ensenyat A, Real J, Castro-Vinuales I, Zapata A, Galindo G, Sole-Mir E, Bosch-Munoz J, Mur JM, Teixido C. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol. BMC Public Health. 2013 Oct 23;13:1000. doi: 10.1186/1471-2458-13-1000.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: To evaluate the effectiveness of the Nereu program compared to standard care (advice on increased physical activity and nutrition) such as a health intervention tool for the childhood obesity management\n\nMethods/Design: The study design is a randomized controlled multicenter clinical trial using two types of treatment. Population and sample: Children 6 to 12 years with overweight or obesity, according to the z score of body mass index (BMI z) \\>= 1 for age and gender defined by International Obesity Task Force (IOTF). It is considered necessary to recruit 100 children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8 month intervention with 3 weekly training sessions doing physical exercise for children and a weekly session for parents of physical activity and healthy eating habits and behaviour strategies, that involves both parental and child participation. The control group will receive a monthly session of healthy physical and eating habits. Main Outcome Measures: Improvement of BMI z, physical activity and nutrition habits, behaviour components and quality life related to health at the end, 6 and 12 months after intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 6 to 12 years old\n* Overweight or obese according to the IOTF criteria\n\nExclusion Criteria:\n\n* Medical co-morbidities: Diabetes mellitus or hypercholesterolemia or cardiovascular disease that could be contraindicate the sport practice.\n* Use of medication that might have an effect on weight loss.\n* previous enrolment in another similar treatment program based on reducing obesity.'}, 'identificationModule': {'nctId': 'NCT01878994', 'acronym': 'NEREU', 'briefTitle': 'Evaluation of a Family Intervention Program for the Management of Overweight or Obese Children', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PI12/02220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Counselling Group', 'description': "Each family will receive a single monthly meeting, a total of 8 with 10 minutes duration each one. The sessions will take place in the consultation of the paediatrician and it will be delivered by the child's nurse or/and paediatrician. The sessions' contents are about promotion of healthy eating and physical activity habits.", 'interventionNames': ['Behavioral: Counselling group']}, {'type': 'EXPERIMENTAL', 'label': 'Nereu Group', 'description': 'The Nereu treatment program is an intensive family-based behavioural multi-component lifestyle intervention. Consist in an intensive treatment of 8 months duration (from October to May, that is, an academic year). The intervention is a multidisciplinary intervention consisting in 4 structured components: (a) physical activity training for children, (b) family theoretical and practical sessions for parents, (c) behaviour strategies, that involves both parental and child participation (d) weekend extra activities.', 'interventionNames': ['Behavioral: Nereu group']}], 'interventions': [{'name': 'Counselling group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Counselling Group']}, {'name': 'Nereu group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Nereu Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25001', 'city': 'Lleida', 'state': 'Lleida', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Conxita Teixidó, Dra', 'role': 'CONTACT', 'email': 'cteixido.lleida.ics@gencat.cat'}], 'facility': 'USR- Lleida. Atenció primaria. IDIAP Jordi Gol', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}], 'centralContacts': [{'name': 'Conepció Teixidó, Phd', 'role': 'CONTACT', 'email': 'cteixido.lleida.ics@gencat.cat'}, {'name': 'Noemí Serra, Mrs', 'role': 'CONTACT', 'email': 'nserra@inefc.es'}], 'overallOfficials': [{'name': 'Noemí Serra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INEFC-LLEIDA, University of Lleida'}, {'name': 'Concepció Teixidó', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Català de la Salut - Atenció primaria - Lleida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Associació NEREU', 'class': 'UNKNOWN'}, {'name': 'INEFC-Lleida', 'class': 'OTHER'}, {'name': 'USR-ICS. Atenció Primària Lleida', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}