Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-06 @ 9:01 PM
Study NCT ID:
NCT02079935
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2014-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Eating Disorders by Physical Activity and Nutrition Counseling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "The one transferring results from lab's and questionaires to SPSS are blinded for group affiliation."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparing treatment of cognitive behavioural therapy, with treatment of physical exercise and dietary therapy. All participants randomized to either of the two treatment offers. Waitlist serves as control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2014-02-17', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in muscular strength', 'timeFrame': 'Pretest (week 0), post-test (week 17) and at 6, 12 and 24 months after treatment', 'description': 'Status of 1 repetition maximum, 1RM, muscular strength in squats, bench press and seated row'}, {'measure': 'Change in cardiovascular endurance', 'timeFrame': 'Pre-test in week 0, Post-tests ( week 17), and at 6, 12 and 24 months after intervention.', 'description': 'CPET: with the use of modified Balke Treadmill performance evaluation test, The Borg scale (Borg, 1982)'}, {'measure': 'Change in bone mineral density', 'timeFrame': 'Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment', 'description': 'DXA (Dual-energy X-ray absorptiometry)'}, {'measure': 'Change in body weight and bodycomposition', 'timeFrame': 'Pre-test and post-test (week 17) and at 6,12,18 and 24 months post-treatment', 'description': 'DXA (dual-energy x-ray absorptiometry) (weekly weight registration will also be kept in each arm of treatment)'}, {'measure': 'Change in nutritional status', 'timeFrame': 'Pre-test, in week 8 of treatment, post-test (week 17) and at 6,12,18 and 24 months post-treatment', 'description': 'Blood test to identify nutritional status of iron, folate, cholesterol and triglycerides, ApoA, ApoB and vitamin-D, folic acid'}, {'measure': 'Change in hormonal status', 'timeFrame': 'Pre-test, week 8 of treatment, post-test (week 17) and at 6,12,18 and 24 months post-treatment', 'description': 'Blood test to evaluate hormonal status of estradiol, progesterone, CTX, P1nP, insulin, leptin, TSH, T3, T4, FSH, LH, cortisol'}, {'measure': 'Change in dietary and nutritional intake', 'timeFrame': 'Pre-test, each 3rd week in treatment (a total of 5 interviews), post-test (week 17), and post-treatment (6,12, and 24 months post-treatment)', 'description': '24 hour recall interview: interview on the intake of food and beverage during the past 24 hours.'}, {'measure': 'Change in physical activity level', 'timeFrame': 'Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment', 'description': 'Wearing a GT3X-BT actigraph accelerometer for 7 consecutive days and making notes on daily activity in 30 minutes intervals'}, {'measure': 'Interview: measure and explore patients experienced treatment satisfaction and outcome/benefits with PED-t.', 'timeFrame': 'Post treatment', 'description': "Qualitative approaches, such as in-depth interviews, will give additional insights into ED-patients' perspectives, notably experiences and satisfaction with the treatment. A sufficient number of participants to meet data saturation criteria are qualitatively interviewed.\n\nData are analyzed in four steps within the framework of systematic text condensation (Malterud 2012)."}, {'measure': 'Interview: What are the theraphists experiences of their contribution to the PED-t program', 'timeFrame': 'Post treatment', 'description': "Qualitative approaches, such as in-depth interviews, will give additional insights into the therapists' perspectives and experiences on delivering a new treatment offer for eating disorder.\n\nData are analyzed in four steps within the framework of systematic text condensation (Malterud 2012)."}, {'measure': 'Interview: What are the experiences of the participants who drop out of the PED-t program?', 'timeFrame': 'Post treatment', 'description': 'Data are analyzed in four steps within the framework of systematic text condensation (Malterud 2012).'}], 'primaryOutcomes': [{'measure': 'Effectiveness of treatment, evaluated through the change in symptoms of eating disorder', 'timeFrame': 'Pre-test in week 0, Post-tests (week 17), and at 6, 12, and 24 months after intervention.', 'description': 'Change in ED-symptoms are evaluated through screening and surveys: EDE-questionaire (Episodes of binge eating, episodes of purging, concern for body weight and appearance)(Fairburn, 2008), Clinical Impairment Assessment (CIA) (Fairburn, 2008), Eating Disorder Inventory-3 (EDI) (Garner, 2004), Eating Disturbance Scale (EDS-5) (Rosenvinge et al., 2000), DSM-5 (APA, 2013)'}], 'secondaryOutcomes': [{'measure': 'Expectations of treatment method for eating disorders', 'timeFrame': 'Pre-test', 'description': 'Interview on the expectations the patients have to the specified treatment method of eating disorders (arm of intervention) EPDEX (Clinton 2001)'}, {'measure': 'Experiences of the treatment method for eating disorders', 'timeFrame': 'Post-test (week 17)', 'description': 'Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention), EPDEX (Clinton 2001)'}, {'measure': 'Associated cost with treatment method', 'timeFrame': 'Pre-test', 'description': 'Calculation of the directly and indirectly cost related to treatment method'}, {'measure': 'Associated cost with treatment method', 'timeFrame': 'Post-test (week 17)', 'description': 'Calculation of the directly and indirectly cost related to treatment method'}, {'measure': 'Associated cost With treatment method', 'timeFrame': 'Post-test (by 6th month post-treatment)', 'description': 'Calculation of the directly and indirectly cost related to treatment method'}, {'measure': 'Associated cost With treatment method', 'timeFrame': 'Post-test (by 12th month post-treatment)', 'description': 'Calculation of the directly and indirectly cost related to treatment method'}, {'measure': 'Associated cost with treatment method', 'timeFrame': 'Post-test (by 24th month post-treatment)', 'description': 'Calculation of the directly and indirectly cost related to treatment method'}, {'measure': 'Global measurement of general psychopathology', 'timeFrame': 'Pre-treatment', 'description': "Beck's Anxiety Inventory (BAI), Beck Depression Inventory (BDI), QoL (Diener), Utrecht Coping List, Resilience Scale for Adults, the outcome rating scale (ORS), the three-factor eating questionnaire (TFEQ), Binge eating Scale (BES), Cantril's Ladder, Exercise dependency test, compulsice exercise test"}, {'measure': 'Global measurement of general psychopathology', 'timeFrame': 'Post-treatment (week 17)', 'description': "Beck's Anxiety Inventory (BAI), Beck Depression Inventory (BDI), QoL (Diener), Utrecht Coping List, Resilience Scale for Adults, the outcome rating scale (ORS), the three-factor eating questionnaire (TFEQ), Binge eating Scale (BES), Cantril's Ladder, Exercise dependency test, compulsice exercise test"}, {'measure': 'Global measurement of general psychopathology', 'timeFrame': 'Post-treatment (by the 6th month post-treatment)', 'description': "Beck's Anxiety Inventory (BAI), Beck Depression Inventory (BDI), QoL (Diener), Utrecht Coping List, Resilience Scale for Adults, the outcome rating scale (ORS), the three-factor eating questionnaire (TFEQ), Binge eating Scale (BES), Cantril's Ladder, Exercise dependency test, compulsice exercise test"}, {'measure': 'Global measurement of general psychopathology', 'timeFrame': 'Post-test (by 12th month post-treatment)', 'description': "Beck's Anxiety Inventory (BAI), Beck Depression Inventory (BDI), QoL (Diener), Utrecht Coping List, Resilience Scale for Adults, the outcome rating scale (ORS), the three-factor eating questionnaire (TFEQ), Binge eating Scale (BES), Cantril's Ladder, Exercise dependency test, compulsice exercise test"}, {'measure': 'Global measurement of general psychopathology', 'timeFrame': 'Post-test (by 24th month post-treatment)', 'description': "Beck's Anxiety Inventory (BAI), Beck Depression Inventory (BDI), QoL (Diener), Utrecht Coping List, Resilience Scale for Adults, the outcome rating scale (ORS), the three-factor eating questionnaire (TFEQ), Binge eating Scale (BES), Cantril's Ladder, Exercise dependency test, compulsice exercise test"}, {'measure': 'Group climate', 'timeFrame': 'week 1-16', 'description': 'coerciveness scale from Therapeutic Factor Inventory (Lese \\& MacNair-Semands, 2000).'}, {'measure': 'Working AIliance', 'timeFrame': 'week 1-16', 'description': 'Working AIliance Inventory (Horwath \\& Greenberg, 1989)'}, {'measure': 'Experiences of the treatment method for eating disorders', 'timeFrame': 'Post-test (6 months)', 'description': 'Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)'}, {'measure': 'Experiences of the treatment method for eating disorders', 'timeFrame': 'Post-test (by 12th month post-treatment)', 'description': 'Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)'}, {'measure': 'Experiences of the treatment method for eating disorders', 'timeFrame': 'Post-test (by 24th month post-treatment)', 'description': 'Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)'}, {'measure': 'Change in eating disorder behavior and cognitions related to body figure and bodyweight', 'timeFrame': 'Week 1-16 during treatment', 'description': 'Evaluation after each therapy session on progress in reducing eating disordered behaviour (binging and purging) and on changes of cognitions on body figure and -weight'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BN', 'Binge', 'overconsumption of food', 'purging', 'purge'], 'conditions': ['Bulimia Nervosa', 'Binge Eating Disorder']}, 'referencesModule': {'references': [{'pmid': '11828224', 'type': 'RESULT', 'citation': 'Sundgot-Borgen J, Rosenvinge JH, Bahr R, Schneider LS. The effect of exercise, cognitive therapy, and nutritional counseling in treating bulimia nervosa. Med Sci Sports Exerc. 2002 Feb;34(2):190-5. doi: 10.1097/00005768-200202000-00002.'}, {'pmid': '37103592', 'type': 'DERIVED', 'citation': 'Mathisen TF, Sundgot-Borgen J, Rosenvinge JH, Bratland-Sanda S, Svendsen M, Pettersen G, Vrabel K, Friborg O. Metabolic profile in women with bulimia nervosa or binge-eating disorder before and after treatment: secondary analysis from the randomized PED-t trial. Eat Weight Disord. 2023 Apr 27;28(1):41. doi: 10.1007/s40519-023-01567-y.'}, {'pmid': '31944339', 'type': 'DERIVED', 'citation': 'Mathisen TF, Rosenvinge JH, Friborg O, Vrabel K, Bratland-Sanda S, Pettersen G, Sundgot-Borgen J. Is physical exercise and dietary therapy a feasible alternative to cognitive behavior therapy in treatment of eating disorders? A randomized controlled trial of two group therapies. Int J Eat Disord. 2020 Apr;53(4):574-585. doi: 10.1002/eat.23228. Epub 2020 Jan 16.'}, {'pmid': '31005919', 'type': 'DERIVED', 'citation': 'Pettersen G, Rosenvinge JH, Skomakerstuen T, Sordal S, Mathisen TF, Sundgot-Borgen J. Patient expectations of a new treatment for eating disorders combining guided physical exercise and dietary therapy: an interview study of women participating in a randomised controlled trial at the Norwegian School of Sport Sciences. BMJ Open. 2019 Apr 20;9(4):e025344. doi: 10.1136/bmjopen-2018-025344.'}, {'pmid': '30559966', 'type': 'DERIVED', 'citation': 'Mathisen TF, Bratland-Sanda S, Rosenvinge JH, Friborg O, Pettersen G, Vrabel KA, Sundgot-Borgen J. Treatment effects on compulsive exercise and physical activity in eating disorders. J Eat Disord. 2018 Dec 13;6:43. doi: 10.1186/s40337-018-0215-1. eCollection 2018.'}, {'pmid': '29473191', 'type': 'DERIVED', 'citation': 'Mathisen TF, Rosenvinge JH, Friborg O, Pettersen G, Stensrud T, Hansen BH, Underhaug KE, Teinung E, Vrabel K, Svendsen M, Bratland-Sanda S, Sundgot-Borgen J. Body composition and physical fitness in women with bulimia nervosa or binge-eating disorder. Int J Eat Disord. 2018 Apr;51(4):331-342. doi: 10.1002/eat.22841. Epub 2018 Feb 23.'}, {'pmid': '29415831', 'type': 'DERIVED', 'citation': 'Mathisen TF, Engen KM, Sundgot-Borgen J, Stensrud T. Evaluation of a short protocol for indirect calorimetry in females with eating disorders and healthy controls. Clin Nutr ESPEN. 2017 Dec;22:28-35. doi: 10.1016/j.clnesp.2017.09.003. Epub 2017 Oct 5.'}, {'pmid': '29330176', 'type': 'DERIVED', 'citation': "Bakland M, Sundgot-Borgen J, Wynn R, Rosenvinge JH, Stornaes AV, Pettersen G. Therapists' experiences with a new treatment combining physical exercise and dietary therapy (the PED-t) for eating disorders: an interview study in a randomised controlled trial at the Norwegian School of Sport Sciences. BMJ Open. 2018 Jan 11;8(1):e019386. doi: 10.1136/bmjopen-2017-019386."}, {'pmid': '29317417', 'type': 'DERIVED', 'citation': "Pettersen G, Rosenvinge JH, Bakland M, Wynn R, Mathisen TF, Sundgot-Borgen J. Patients' and therapists' experiences with a new treatment programme for eating disorders that combines physical exercise and dietary therapy: the PED-t trial. A qualitative study protocol. BMJ Open. 2018 Jan 8;8(1):e018708. doi: 10.1136/bmjopen-2017-018708."}, {'pmid': '29259061', 'type': 'DERIVED', 'citation': 'Pettersen G, Sordal S, Rosenvinge JH, Skomakerstuen T, Mathisen TF, Sundgot-Borgen J. How do women with eating disorders experience a new treatment combining guided physical exercise and dietary therapy? An interview study of women participating in a randomised controlled trial at the Norwegian School of Sport Sciences. BMJ Open. 2017 Dec 19;7(12):e018588. doi: 10.1136/bmjopen-2017-018588.'}, {'pmid': '28494809', 'type': 'DERIVED', 'citation': 'Mathisen TF, Rosenvinge JH, Pettersen G, Friborg O, Vrabel K, Bratland-Sanda S, Svendsen M, Stensrud T, Bakland M, Wynn R, Sundgot-Borgen J. The PED-t trial protocol: The effect of physical exercise -and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder. BMC Psychiatry. 2017 May 12;17(1):180. doi: 10.1186/s12888-017-1312-4.'}], 'seeAlsoLinks': [{'url': 'http://www.nih.no/en/', 'label': 'Norwegian School of Sports Sciences'}, {'url': 'http://www.sanitetskvinnene.no/', 'label': "The Norwegian Women's Public Health Association"}, {'url': 'http://en.uit.no/startsida', 'label': 'University of Tromsø'}, {'url': 'http://translate.google.com/translate?hl=no&langpair=no%7Cen&u=http://www.modum-bad.no/', 'label': 'Modum Bad'}, {'url': 'http://nihfakt.blogspot.no/', 'label': 'Recruitment webpage'}]}, 'descriptionModule': {'briefSummary': '"Eating disorders" includes anorexia nervosa, bulimia nervosa, binge eating and other specified feeding or eating disorder (OSFED). Common to all is the intensively occupation to control food intake, body image and body weight. Most people with this kind of disorder don\'t reach for professional help, or there may be more than 4 years before they do. Cognitive behavior therapy is the foremost method of treatment of eating disorders, but up to 30-50% of the patients don\'t respond to this. The investigators find it important to identify science based alternatives of therapy, as this may reduce the health concern, and broaden the choice of therapy methods. A former study by Sundgot-Borgen et al in 2002, found guided physical activity to reduce symptoms of bulimia nervosa just as good as the traditional cognitive therapy.\n\nThe primary objective of the project is to see whether the combination of physical exercise and dietary therapy is more effective in treating eating disorders, than cognitive therapy.\n\nSecondly, the investigators want to see whether there are any differences with regard to the individual satisfaction of treatment method, and to associated costs. Interviews with a sufficient number of participants from the PED-t arm to meet data saturation criteria, and all theraphists in the new treatment offer, will give uniqe insight to experiences with the treatment method and the delivery of treatment.', 'detailedDescription': 'Subjects are recruited through primary doctors, social media and newspapers, and will be included continuously by screening interviews. There will be a randomization into two treatment groups (cognitive behavior, or physical activity and nutrition education) to be followed for 16 weeks. Each week includes one meeting of group therapy (90 minutes) and homework related to treatment, and for 4 weeks midway there will be two therapy meetings pr week (a total of 20 meetings). Post tests are planned at week 17, and at 6, 12, and 24 months after treatment.\n\nParticipants reqruited during ongoing treatment groups are placed on a waitlist, serving as controls to the treatment groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women,\n* BMI 17,5-35,\n* Age of 18-40 years,\n* DSM-5 criteria of bulimia nervosa,\n* DSM-5 criteria of Binge eating disorder\n* Living nearby Norwegian School of Sports Sciences, NSSS, in Oslo (Norway)\n\nExclusion Criteria:\n\n* Age \\<18 and \\>40 years\n* BMI \\<17,5 and \\>35\n* Pregnancy\n* Competing/experienced athlete\n* Anorexia nervosa\n* Currently, or during the past 2 years, in active treatment with cognitive therapy\n* Other personality disturbances\n* Suicidality'}, 'identificationModule': {'nctId': 'NCT02079935', 'acronym': 'FAKT', 'briefTitle': 'Treatment of Eating Disorders by Physical Activity and Nutrition Counseling', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian School of Sport Sciences'}, 'officialTitle': 'Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study', 'orgStudyIdInfo': {'id': '2013/344'}, 'secondaryIdInfos': [{'id': '2013/1871', 'type': 'OTHER_GRANT', 'domain': 'Regional Committees for Medical and Health Research Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behaviour Therapy', 'description': 'Treatment with small groups following a modified protocol first described by Fairburn 2008', 'interventionNames': ['Behavioral: Cognitive Behaviour Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Physical activity and dietary therapy', 'description': 'Treatment with guided physical activity and dietary therapy in small groups', 'interventionNames': ['Behavioral: Physical Activity and Dietary Therapy']}], 'interventions': [{'name': 'Cognitive Behaviour Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['CBT-ED', 'CBT-enhanced', 'CBT-e'], 'description': 'Following group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway.', 'armGroupLabels': ['Cognitive Behaviour Therapy']}, {'name': 'Physical Activity and Dietary Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['PADT', 'FAKT', 'PED-t'], 'description': 'Guided physical activity and dietary therapy, to (re-)introduce a more healthy lifestyle and help stabilizing a healthy weight. A detailed manual will be published.', 'armGroupLabels': ['Physical activity and dietary therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0806', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Norwegian School of Sports Sciences', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Jorunn Sundgot-Borgen, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Norwegian School of Sports Sciences'}, {'name': 'Therese F Mathisen, PhDcandidate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian School of Sports Sciences'}, {'name': 'Jan Rosenvinge, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Tromso'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian School of Sport Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Norwegian Women´s Public Health Association', 'class': 'OTHER'}, {'name': 'University of Tromso', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Professor Jorunn Sundgot-Borgen', 'investigatorAffiliation': 'Norwegian School of Sport Sciences'}}}}