Treatment of Eating Disorders by Physical Activity and Nutrition Counseling
FAKT
2 other identifiers
interventional
128
1 country
1
Brief Summary
"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. The 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. Secondly, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedMarch 13, 2019
March 1, 2019
4.9 years
February 17, 2014
March 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness of treatment, evaluated through the change in symptoms of eating disorder
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)
Pre-test in week 0, Post-tests (week 17), and at 6, 12, and 24 months after intervention.
Secondary Outcomes (18)
Expectations of treatment method for eating disorders
Pre-test
Experiences of the treatment method for eating disorders
Post-test (week 17)
Associated cost with treatment method
Pre-test
Associated cost with treatment method
Post-test (week 17)
Associated cost With treatment method
Post-test (by 6th month post-treatment)
- +13 more secondary outcomes
Other Outcomes (11)
Change in muscular strength
Pretest (week 0), post-test (week 17) and at 6, 12 and 24 months after treatment
Change in cardiovascular endurance
Pre-test in week 0, Post-tests ( week 17), and at 6, 12 and 24 months after intervention.
Change in bone mineral density
Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment
- +8 more other outcomes
Study Arms (2)
Cognitive Behaviour Therapy
EXPERIMENTALTreatment with small groups following a modified protocol first described by Fairburn 2008
Physical activity and dietary therapy
EXPERIMENTALTreatment with guided physical activity and dietary therapy in small groups
Interventions
Following group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway.
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.
Eligibility Criteria
You may qualify if:
- Women,
- BMI 17,5-35,
- Age of 18-40 years,
- DSM-5 criteria of bulimia nervosa,
- DSM-5 criteria of Binge eating disorder
- Living nearby Norwegian School of Sports Sciences, NSSS, in Oslo (Norway)
You may not qualify if:
- Age \<18 and \>40 years
- BMI \<17,5 and \>35
- Pregnancy
- Competing/experienced athlete
- Anorexia nervosa
- Currently, or during the past 2 years, in active treatment with cognitive therapy
- Other personality disturbances
- Suicidality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian School of Sport Scienceslead
- The Norwegian Women´s Public Health Associationcollaborator
- University of Tromsocollaborator
Study Sites (1)
Norwegian School of Sports Sciences
Oslo, 0806, Norway
Related Publications (11)
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: 11828224RESULTMathisen 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: 37103592DERIVEDMathisen 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: 31944339DERIVEDPettersen 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: 31005919DERIVEDMathisen 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: 30559966DERIVEDMathisen 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: 29473191DERIVEDMathisen 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: 29415831DERIVEDBakland 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: 29330176DERIVEDPettersen 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: 29317417DERIVEDPettersen 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: 29259061DERIVEDMathisen 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.
PMID: 28494809DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jorunn Sundgot-Borgen, Professor
Norwegian School of Sports Sciences
- PRINCIPAL INVESTIGATOR
Therese F Mathisen, PhDcandidate
Norwegian School of Sports Sciences
- STUDY DIRECTOR
Jan Rosenvinge, Professor
University of Tromso
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The one transferring results from lab's and questionaires to SPSS are blinded for group affiliation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 17, 2014
First Posted
March 6, 2014
Study Start
March 1, 2014
Primary Completion
January 31, 2019
Study Completion
January 31, 2019
Last Updated
March 13, 2019
Record last verified: 2019-03