Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-21 @ 6:53 PM
Study NCT ID:
NCT02180802
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2014-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-30', 'studyFirstSubmitDate': '2014-07-01', 'studyFirstSubmitQcDate': '2014-07-01', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in BMI', 'timeFrame': 'changes from baseline and 12 months follow-up', 'description': 'Body Mass Index'}, {'measure': 'Child Dietary Self-Efficacy', 'timeFrame': 'changes from baseline and 12 months follow-up', 'description': 'Child Dietary Self-Efficacy Scale (CDSS)'}, {'measure': 'Weight Efficacy Lifestyle', 'timeFrame': 'changes from baseline and 12 months follow-up', 'description': 'Weight Efficacy Lifestyle questionnaire (WEL)'}, {'measure': 'Physical Exercise Self-efficacy', 'timeFrame': 'changes from baseline and 12 months follow-up', 'description': 'Physical Exercise Self-efficacy Scale (PES)'}, {'measure': 'changes in physical activity', 'timeFrame': 'changes from baseline and 12 months follow-up'}, {'measure': 'changes in dietary pattern', 'timeFrame': 'changes from baseline and 12 months follow-up'}], 'secondaryOutcomes': [{'measure': 'Changes in blood cholesterol level', 'timeFrame': 'changes from baseline and 12 months follow-up'}, {'measure': 'changes in blood triglyceride level', 'timeFrame': 'changes from baseline and 12 months follow-up'}, {'measure': 'Changes in body fat percentage', 'timeFrame': 'changes from baseline and 12 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obese adolescents', 'BMI ≥ 95th percentile for age and gender'], 'conditions': ['Obesity, Adolescent']}, 'descriptionModule': {'briefSummary': 'Motivational interviewing (MI) has been shown to be an effective strategy in targeting obesity in adolescents and parental involvement has been associated with increased effectiveness. The aim of the study is to evaluate and compare the role of parental involvement in MI interventions for obese adolescents'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI equal or higher than 95th percentile for age and gender\n* 13-18 years old\n\nExclusion Criteria:\n\n* medication with weight gain as side effects\n* diagnosed with having eating disorder\n* pregnant\n* clinical mental health conditions\n* psychosis'}, 'identificationModule': {'nctId': 'NCT02180802', 'briefTitle': 'Parental Involvement Improves the Effect of Motivational Interviewing on Weight Loss in Obese Adolescents: A Randomized Controlled Trial Study', 'organization': {'class': 'OTHER', 'fullName': 'Qazvin University Of Medical Sciences'}, 'orgStudyIdInfo': {'id': '3287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'motivational intervieing group', 'description': 'The behavioral intervention targets were improved eating and physical activity behavior in order to reduce obesity levels. Each adolescent was encouraged to eat a variety of foods from each of the four major food groups and low-fat alternatives . Moreover, each adolescent was encouraged to achieve at least 60 minutes of moderate-to-vigorous intensity physical activity daily as recommended by the World Health Organization', 'interventionNames': ['Behavioral: motivational interviewing']}, {'type': 'EXPERIMENTAL', 'label': 'motivational interviewi group with parental involvement', 'description': 'an additional single session with parents or guardians over 60 minutes in the clinic', 'interventionNames': ['Behavioral: motivational interviewing with parental involvement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The patients received routine care', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'motivational interviewing', 'type': 'BEHAVIORAL', 'armGroupLabels': ['motivational intervieing group']}, {'name': 'motivational interviewing with parental involvement', 'type': 'BEHAVIORAL', 'armGroupLabels': ['motivational interviewi group with parental involvement']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qazvin', 'state': 'Qazvin Province', 'country': 'Iran', 'facility': 'Outpatient Pediatric Clinic', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qazvin University Of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice dean for research', 'investigatorFullName': 'Amir H Pakpour', 'investigatorAffiliation': 'Qazvin University Of Medical Sciences'}}}}