Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-05 @ 2:12 PM
Study NCT ID:
NCT02745795
Status:
UNKNOWN
Last Update Posted:
2016-04-20
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-17', 'studyFirstSubmitDate': '2016-04-05', 'studyFirstSubmitQcDate': '2016-04-17', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivation scores to adhere to a diet and physical activity plan', 'timeFrame': 'Six months', 'description': 'Motivation scores assessed by two self-report confidential paper questionnaires (Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet and Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise)'}], 'secondaryOutcomes': [{'measure': 'Self-concept score', 'timeFrame': 'Six months', 'description': 'Self-report score assessed by a paper questionnaire (Self Perception Profile for Children)'}, {'measure': 'Quality of life score', 'timeFrame': 'Six months', 'description': 'Quality of life score assessed by Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)'}, {'measure': 'Depressive symptoms score', 'timeFrame': 'Six months', 'description': 'Depressive symptoms score assessed by Children Depression Inventory (CDI)'}, {'measure': 'Anxiety symptoms', 'timeFrame': 'Six months', 'description': 'Anxiety score symptoms assessed by State-Trait Anxiety Inventory for Children (STAIC C-2)'}, {'measure': 'Abdominal circumference in centimeters', 'timeFrame': 'Six months', 'description': 'Abdominal circumference measured with Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany)'}, {'measure': 'Blood pressure in mm Hg', 'timeFrame': 'Six months', 'description': 'Blood pressure measured with Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany)'}, {'measure': 'Weight in kilograms', 'timeFrame': 'Six months', 'description': 'Weight measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan)'}, {'measure': 'Height in meters', 'timeFrame': 'Six months', 'description': 'Height in meters measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Motivational interview', 'adolescents', 'obesity', 'overweight', 'physical activity', 'diet'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '19178654', 'type': 'BACKGROUND', 'citation': 'Physical Activity Guidelines Advisory Committee report, 2008. To the Secretary of Health and Human Services. Part A: executive summary. Nutr Rev. 2009 Feb;67(2):114-20. doi: 10.1111/j.1753-4887.2008.00136.x. No abstract available.'}, {'pmid': '17716083', 'type': 'BACKGROUND', 'citation': 'Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.'}, {'pmid': '21554994', 'type': 'BACKGROUND', 'citation': 'Bean MK, Mazzeo SE, Stern M, Bowen D, Ingersoll K. A values-based Motivational Interviewing (MI) intervention for pediatric obesity: study design and methods for MI Values. Contemp Clin Trials. 2011 Sep;32(5):667-74. doi: 10.1016/j.cct.2011.04.010. Epub 2011 Apr 29.'}, {'pmid': '25240070', 'type': 'BACKGROUND', 'citation': 'Tanofsky-Kraff M, Shomaker LB, Wilfley DE, Young JF, Sbrocco T, Stephens M, Ranzenhofer LM, Elliott C, Brady S, Radin RM, Vannucci A, Bryant EJ, Osborn R, Berger SS, Olsen C, Kozlosky M, Reynolds JC, Yanovski JA. Targeted prevention of excess weight gain and eating disorders in high-risk adolescent girls: a randomized controlled trial. Am J Clin Nutr. 2014 Oct;100(4):1010-8. doi: 10.3945/ajcn.114.092536. Epub 2014 Aug 13.'}, {'pmid': '20233144', 'type': 'BACKGROUND', 'citation': 'de Onis M, Lobstein T. Defining obesity risk status in the general childhood population: which cut-offs should we use? Int J Pediatr Obes. 2010 Dec;5(6):458-60. doi: 10.3109/17477161003615583. Epub 2010 Mar 17. No abstract available.'}, {'pmid': '21878034', 'type': 'BACKGROUND', 'citation': 'Aviram A, Westra HA. The impact of motivational interviewing on resistance in cognitive behavioural therapy for generalized anxiety disorder. Psychother Res. 2011 Nov;21(6):698-708. doi: 10.1080/10503307.2011.610832. Epub 2011 Aug 31.'}, {'pmid': '17243492', 'type': 'BACKGROUND', 'citation': 'Kosti RI, Panagiotakos DB. The epidemic of obesity in children and adolescents in the world. Cent Eur J Public Health. 2006 Dec;14(4):151-9. doi: 10.21101/cejph.a3398.'}, {'pmid': '11574336', 'type': 'BACKGROUND', 'citation': 'Resnicow K, Jackson A, Wang T, De AK, McCarty F, Dudley WN, Baranowski T. A motivational interviewing intervention to increase fruit and vegetable intake through Black churches: results of the Eat for Life trial. Am J Public Health. 2001 Oct;91(10):1686-93. doi: 10.2105/ajph.91.10.1686.'}, {'pmid': '11453198', 'type': 'BACKGROUND', 'citation': "Faria L. Harter's self-perception profile for children adapted for use with young Portuguese students. Percept Mot Skills. 2001 Jun;92(3 Pt 1):711-20. doi: 10.2466/pms.2001.92.3.711."}, {'pmid': '23970960', 'type': 'BACKGROUND', 'citation': 'Gee S, Chin D, Ackerson L, Woo D, Howell A. Prevalence of childhood and adolescent overweight and obesity from 2003 to 2010 in an integrated health care delivery system. J Obes. 2013;2013:417907. doi: 10.1155/2013/417907. Epub 2013 Jul 18.'}, {'pmid': '4089116', 'type': 'BACKGROUND', 'citation': "Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available."}, {'pmid': '11468499', 'type': 'BACKGROUND', 'citation': 'Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.'}, {'pmid': '16186441', 'type': 'BACKGROUND', 'citation': 'Gidding SS, Dennison BA, Birch LL, Daniels SR, Gillman MW, Lichtenstein AH, Rattay KT, Steinberger J, Stettler N, Van Horn L; American Heart Association; American Academy of Pediatrics. Dietary recommendations for children and adolescents: a guide for practitioners: consensus statement from the American Heart Association. Circulation. 2005 Sep 27;112(13):2061-75. doi: 10.1161/CIRCULATIONAHA.105.169251.'}, {'pmid': '20965379', 'type': 'BACKGROUND', 'citation': 'Neumark-Sztainer DR, Friend SE, Flattum CF, Hannan PJ, Story MT, Bauer KW, Feldman SB, Petrich CA. New moves-preventing weight-related problems in adolescent girls a group-randomized study. Am J Prev Med. 2010 Nov;39(5):421-32. doi: 10.1016/j.amepre.2010.07.017.'}, {'pmid': '21802570', 'type': 'BACKGROUND', 'citation': 'Flattum C, Friend S, Story M, Neumark-Sztainer D. Evaluation of an individualized counseling approach as part of a multicomponent school-based program to prevent weight-related problems among adolescent girls. J Am Diet Assoc. 2011 Aug;111(8):1218-23. doi: 10.1016/j.jada.2011.05.008.'}, {'pmid': '20369454', 'type': 'BACKGROUND', 'citation': 'Feinson J, Atkinson A, Hassink S. How a primary care quality improvement initiative is implementing the expert recommendations on childhood obesity. Del Med J. 2010 Feb;82(2):57-65.'}, {'pmid': '19879918', 'type': 'BACKGROUND', 'citation': 'Lang PJ, Bradley MM. Emotion and the motivational brain. Biol Psychol. 2010 Jul;84(3):437-50. doi: 10.1016/j.biopsycho.2009.10.007. Epub 2009 Oct 30.'}, {'pmid': '17902211', 'type': 'BACKGROUND', 'citation': 'Wang Y, Lobstein T. Worldwide trends in childhood overweight and obesity. Int J Pediatr Obes. 2006;1(1):11-25. doi: 10.1080/17477160600586747.'}, {'pmid': '17126634', 'type': 'BACKGROUND', 'citation': 'Resnicow K, Davis R, Rollnick S. Motivational interviewing for pediatric obesity: Conceptual issues and evidence review. J Am Diet Assoc. 2006 Dec;106(12):2024-33. doi: 10.1016/j.jada.2006.09.015.'}, {'pmid': '12799128', 'type': 'BACKGROUND', 'citation': 'Neumark-Sztainer D, Story M, Hannan PJ, Rex J. New Moves: a school-based obesity prevention program for adolescent girls. Prev Med. 2003 Jul;37(1):41-51. doi: 10.1016/s0091-7435(03)00057-4.'}, {'pmid': '10620381', 'type': 'BACKGROUND', 'citation': 'Ryan RM, Deci EL. Intrinsic and Extrinsic Motivations: Classic Definitions and New Directions. Contemp Educ Psychol. 2000 Jan;25(1):54-67. doi: 10.1006/ceps.1999.1020.'}, {'pmid': '22654546', 'type': 'BACKGROUND', 'citation': 'Ball GD, Mackenzie-Rife KA, Newton MS, Alloway CA, Slack JM, Plotnikoff RC, Goran MI. One-on-one lifestyle coaching for managing adolescent obesity: Findings from a pilot, randomized controlled trial in a real-world, clinical setting. Paediatr Child Health. 2011 Jun;16(6):345-50. doi: 10.1093/pch/16.6.345.'}, {'pmid': '19103327', 'type': 'BACKGROUND', 'citation': 'Flattum C, Friend S, Neumark-Sztainer D, Story M. Motivational interviewing as a component of a school-based obesity prevention program for adolescent girls. J Am Diet Assoc. 2009 Jan;109(1):91-4. doi: 10.1016/j.jada.2008.10.003.'}, {'pmid': '14516234', 'type': 'BACKGROUND', 'citation': 'Burke BL, Arkowitz H, Menchola M. The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials. J Consult Clin Psychol. 2003 Oct;71(5):843-61. doi: 10.1037/0022-006X.71.5.843.'}, {'pmid': '16651347', 'type': 'BACKGROUND', 'citation': 'Council on Sports Medicine and Fitness; Council on School Health. Active healthy living: prevention of childhood obesity through increased physical activity. Pediatrics. 2006 May;117(5):1834-42. doi: 10.1542/peds.2006-0472.'}, {'pmid': '15723728', 'type': 'BACKGROUND', 'citation': 'Moyers TB, Martin T, Manuel JK, Hendrickson SM, Miller WR. Assessing competence in the use of motivational interviewing. J Subst Abuse Treat. 2005 Jan;28(1):19-26. doi: 10.1016/j.jsat.2004.11.001.'}, {'pmid': '19625970', 'type': 'BACKGROUND', 'citation': 'Lurbe E, Cifkova R, Cruickshank JK, Dillon MJ, Ferreira I, Invitti C, Kuznetsova T, Laurent S, Mancia G, Morales-Olivas F, Rascher W, Redon J, Schaefer F, Seeman T, Stergiou G, Wuhl E, Zanchetti A; European Society of Hypertension. Management of high blood pressure in children and adolescents: recommendations of the European Society of Hypertension. J Hypertens. 2009 Sep;27(9):1719-42. doi: 10.1097/HJH.0b013e32832f4f6b.'}, {'pmid': '20939628', 'type': 'BACKGROUND', 'citation': 'Irby M, Kaplan S, Garner-Edwards D, Kolbash S, Skelton JA. Motivational interviewing in a family-based pediatric obesity program: a case study. Fam Syst Health. 2010 Sep;28(3):236-46. doi: 10.1037/a0020101.'}, {'pmid': '15286277', 'type': 'BACKGROUND', 'citation': 'National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.'}, {'pmid': '29766325', 'type': 'DERIVED', 'citation': 'Freira S, Lemos MS, Fonseca H, Williams G, Ribeiro M, Pena F, do Ceu Machado M. Anthropometric outcomes of a motivational interviewing school-based randomized trial involving adolescents with overweight. Eur J Pediatr. 2018 Jul;177(7):1121-1130. doi: 10.1007/s00431-018-3158-2. Epub 2018 May 15.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to investigate the efficacy of motivational interview intervention with adolescent students at a school environment on the adhesion to a therapeutic plan to loose weight.', 'detailedDescription': "Motivational interview (MI) is a style of communication collaborative, objective-directed, with special attention to change talk.\n\nThe present study's main objective is to investigate the efficacy of a MI intervention in adolescents with weight excess, in a school setting, over their motivation to adhere to a health lifestyle plan of dietary habits and physical exercise.\n\nSecondary objectives are to investigate the effect of MI over self-concept, quality of life, depressive symptoms, anxiety symptoms, body mass index, abdominal circumference and blood pressure.\n\nRegistry Procedures Data on anthropometric parameters is recorded in data collection sheet and stored in individual files, which are available for monitoring procedures and for auditing by the Metabolic and Food Behavior Disorders Scientific Committee.\n\nData Checks Data checks will be performed to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry\n\nSource Data Verification All the data will be checked to assess accuracy, completeness, or representativeness of registry data by comparing the data to external data sources: audio-taped interviews, paper case report forms and paper case self-report forms. All the registries will be stored during five years after study completions according to the Medical Faculty of Lisbon norms.\n\nVariables:\n\nMotivational Interview Audio-taped clinical interview record Motivational Interviewing Treatment Integrity (MITI) version 3.1.1\n\nMotivation to adhere to a physical exercise plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain an healthy diet\n\nMotivation to adhere to a diet plan Self-report by a paper questionnaire Self-regulation and perceived competence questionnaire to begin or maintain regular physical exercise\n\nSelf-concept Self-report by a paper questionnaire Self Perception Profile for Children\n\nQuality of life Self-report by a paper questionnaire Pediatric Quality of Life Inventory 4.0 (PEDSQL 4.0)\n\nDepressive symptoms Self-report by a paper questionnaire Children Depression Inventory (CDI)\n\nAnxiety symptoms Self-report by a paper questionnaire State-Trait Anxiety Inventory for Children (STAIC C-2)\n\nBody mass index Calculated by the ratio of weight in kilograms over the square of height in meters\\^2.\n\nWeight Direct measurement by the research team Measured with Omron Body Composition Monitor with Scale BF 11® (Omron®, Kyoto, Japan) in kilograms\n\nHeight Direct measurement by the research team Measured with Seca® 213 Portable Stadiometer Height-Rod® (Seca@, Hamburg, Germany) in meters\n\nAbdominal circumference Direct measurement by the research team Seca 203 Circumference Measuring Tape® (Seca@, Hamburg, Germany) in centimeters\n\nBlood pressure Direct measurement by the research team Riester Risan Sphygmomanometer® (Riester®, Jungingen, Germany) in mm Hg"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 14 and 19 years old\n* Body mass index percentile equal or above 85th percentile according to World Health Organization charts (de Onis 2010)\n\nExclusion Criteria (one or more of the following):\n\n* recent weight loss of 10% or more of body weight\n* pregnancy\n* breastfeeding\n* endocrine disease\n* present therapy with antidepressant or hypoglycemic drugs\n* present treatment for food behavior disease or depression\n* cognitive impairment of the student or his/her legal tutor.'}, 'identificationModule': {'nctId': 'NCT02745795', 'acronym': 'IMAGINE', 'briefTitle': 'Efficacy of Motivational Interview in the Treatment of Obesity and Overweight in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar Lisboa Norte'}, 'officialTitle': 'Motivational Intervention Through the Generation of an Interpersonal Plan About Nutrition and Physical Exercise Study (IMAGINE Study), a Randomized Controlled Trial With Obese and Overweight Adolescents in Portuguese High Schools', 'orgStudyIdInfo': {'id': 'CC-336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MIG: Motivational Interview Group', 'description': 'Group submitted to three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.', 'interventionNames': ['Behavioral: Motivational Interview']}, {'type': 'SHAM_COMPARATOR', 'label': 'CIG: Conventional Intervention Group', 'description': 'Group submitted to three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.', 'interventionNames': ['Behavioral: Conventional Interview']}], 'interventions': [{'name': 'Motivational Interview', 'type': 'BEHAVIORAL', 'description': 'Three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.', 'armGroupLabels': ['MIG: Motivational Interview Group']}, {'name': 'Conventional Interview', 'type': 'BEHAVIORAL', 'description': 'Three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.', 'armGroupLabels': ['CIG: Conventional Intervention Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marina Serra-de-Lemos, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Psychology and Education Sciences of University of Porto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar Lisboa Norte', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lisbon', 'class': 'OTHER'}, {'name': 'Faculdade de Psicologia e de Ciências de Educação da Universidade do Porto', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Department of Pediatry of Centro Hospitalar Lisboa Norte, Chair of Pediatry at Medicine School of the University of Lisbon', 'investigatorFullName': 'Maria do Céu Machad', 'investigatorAffiliation': 'Centro Hospitalar Lisboa Norte'}}}}