Bulimia NervosaFAKTNCT02079935
Treatment of Eating Disorders by Physical Activity and Nutrition Counseling
A study testing Cognitive Behaviour Therapy and Physical Activity and Dietary Therapy in people with Bulimia Nervosa and Binge Eating Disorder, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bulimia Nervosa, Binge Eating Disorder
- What is being tested?
- Cognitive Behaviour Therapy and Physical Activity and Dietary Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2014to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study
"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.
Read the detailed description
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.
Participants reqruited during ongoing treatment groups are placed on a waitlist, serving as controls to the treatment groups.
- Conditions
- Bulimia Nervosa, Binge Eating Disorder
- Being tested
- Cognitive Behaviour Therapy, Physical Activity and Dietary Therapy
- Keywords
- BN, Binge, overconsumption of food, purging, purge
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour TherapyBehavioural
Also called CBT-ED, CBT-enhanced, CBT-e
Following group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway.
Physical Activity and Dietary TherapyBehavioural
Also called PADT, FAKT, PED-t
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behaviour Therapy | Experimental | Treatment with small groups following a modified protocol first described by Fairburn 2008 Receives: Behavioral: Cognitive Behaviour Therapy |
| Physical activity and dietary therapy | Experimental | Treatment with guided physical activity and dietary therapy in small groups Receives: Behavioral: Physical Activity and Dietary Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Interview on the expectations the patients have to the specified treatment method of eating disorders (arm of intervention) EPDEX (Clinton 2001)
Measured: Pre-test
Experiences of the treatment method for eating disorders
Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention), EPDEX (Clinton 2001)
Measured: Post-test (week 17)
Associated cost with treatment method
Calculation of the directly and indirectly cost related to treatment method
Measured: Pre-test
Associated cost with treatment method
Calculation of the directly and indirectly cost related to treatment method
Measured: Post-test (week 17)
Associated cost With treatment method
Calculation of the directly and indirectly cost related to treatment method
Measured: Post-test (by 6th month post-treatment)
Associated cost With treatment method
Calculation of the directly and indirectly cost related to treatment method
Measured: Post-test (by 12th month post-treatment)
Associated cost with treatment method
Calculation of the directly and indirectly cost related to treatment method
Measured: Post-test (by 24th month post-treatment)
Global measurement of general psychopathology
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
Measured: Pre-treatment
Global measurement of general psychopathology
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
Measured: Post-treatment (week 17)
Global measurement of general psychopathology
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
Measured: Post-treatment (by the 6th month post-treatment)
Global measurement of general psychopathology
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
Measured: Post-test (by 12th month post-treatment)
Global measurement of general psychopathology
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
Measured: Post-test (by 24th month post-treatment)
Group climate
coerciveness scale from Therapeutic Factor Inventory (Lese \& MacNair-Semands, 2000).
Measured: week 1-16
Working AIliance
Working AIliance Inventory (Horwath \& Greenberg, 1989)
Measured: week 1-16
Experiences of the treatment method for eating disorders
Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)
Measured: Post-test (6 months)
Experiences of the treatment method for eating disorders
Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)
Measured: Post-test (by 12th month post-treatment)
Experiences of the treatment method for eating disorders
Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)
Measured: Post-test (by 24th month post-treatment)
Change in eating disorder behavior and cognitions related to body figure and bodyweight
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
Measured: Week 1-16 during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association, University of Tromso
- Responsible party
- Principal investigator, Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences
- Investigators
- Jorunn Sundgot-Borgen, Professor, Study chair, Norwegian School of Sport SciencesTherese F Mathisen, PhDcandidate, Principal investigator, Norwegian School of Sport SciencesJan Rosenvinge, Professor, Study director, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079935
- Sponsor's protocol ID
- 2013/344
- Other IDs
- 2013/1871
- Acronym
- FAKT
- Status last verified
- Mar 2019
- First submitted
- 17 Feb 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 11828224Mathisen 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.
PubMed 37103592Mathisen 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.
PubMed 31944339Pettersen 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.
PubMed 31005919Mathisen 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.
PubMed 30559966Mathisen 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.
PubMed 29473191Mathisen 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.
PubMed 29415831Bakland 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.
PubMed 29330176Pettersen 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.
PubMed 29317417Pettersen 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.
PubMed 29259061Mathisen 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.
PubMed 28494809
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study
- ClinicalTrials.gov ID
- NCT02079935
- Acronym / sponsor ID
- FAKT / 2013/344
- Conditions
- Bulimia Nervosa, Binge Eating Disorder
- Keywords
- BN, Binge, overconsumption of food, purging, purge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- The Norwegian Women´s Public Health Association, University of Tromso
- Study start
- Mar 2014 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Detailed description
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.
Participants reqruited during ongoing treatment groups are placed on a waitlist, serving as controls to the treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behaviour Therapy | Experimental | Behavioral: Cognitive Behaviour TherapyTreatment with small groups following a modified protocol first described by Fairburn 2008 |
| Physical activity and dietary therapy | Experimental | Behavioral: Physical Activity and Dietary TherapyTreatment with guided physical activity and dietary therapy in small groups |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women,
- BMI 17,5-35,
- Age of 18-40 years,
- DSM-5 criteria of bulimia nervosa,
- DSM-5 criteria of Binge eating disorder
Key exclusion criteria (8 listed)
- Age <18 and >40 years
- BMI <17,5 and >35
- Pregnancy
- Competing/experienced athlete
- Anorexia nervosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behaviour TherapyAlso: CBT-ED, CBT-enhanced, CBT-eFollowing group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway. | Behavioural | Cognitive Behaviour Therapy |
| Physical Activity and Dietary TherapyAlso: PADT, FAKT, PED-tGuided physical activity and dietary therapy, to (re-)introduce a more healthy lifestyle and help stabilizing a healthy weight. A detailed manual will be published. | Behavioural | Physical activity and dietary therapy |
Primary outcome
Effectiveness of treatment, evaluated through the change in symptoms of eating disorder
Time frame: Pre-test in week 0, Post-tests (week 17), and at 6, 12, and 24 months after intervention.
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)
18 secondary outcomes
Expectations of treatment method for eating disorders
Time frame: Pre-test
Experiences of the treatment method for eating disorders
Time frame: Post-test (week 17)
Associated cost with treatment method
Time frame: Pre-test
Associated cost with treatment method
Time frame: Post-test (week 17)
Associated cost With treatment method
Time frame: Post-test (by 6th month post-treatment)
Associated cost With treatment method
Time frame: Post-test (by 12th month post-treatment)
Associated cost with treatment method
Time frame: Post-test (by 24th month post-treatment)
Global measurement of general psychopathology
Time frame: Pre-treatment
Global measurement of general psychopathology
Time frame: Post-treatment (week 17)
Global measurement of general psychopathology
Time frame: Post-treatment (by the 6th month post-treatment)
Global measurement of general psychopathology
Time frame: Post-test (by 12th month post-treatment)
Global measurement of general psychopathology
Time frame: Post-test (by 24th month post-treatment)
Group climate
Time frame: week 1-16
Working AIliance
Time frame: week 1-16
Experiences of the treatment method for eating disorders
Time frame: Post-test (6 months)
Experiences of the treatment method for eating disorders
Time frame: Post-test (by 12th month post-treatment)
Experiences of the treatment method for eating disorders
Time frame: Post-test (by 24th month post-treatment)
Change in eating disorder behavior and cognitions related to body figure and bodyweight
Time frame: Week 1-16 during treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Results publication: PubMed 11828224Sundgot-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.
- Derived from this study: PubMed 37103592Mathisen 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.
- Derived from this study: PubMed 31944339Mathisen 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.
- Derived from this study: PubMed 31005919Pettersen 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.
- Derived from this study: PubMed 30559966Mathisen 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.
- Derived from this study: PubMed 29473191Mathisen 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.
- Derived from this study: PubMed 29415831Mathisen 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.
- Derived from this study: PubMed 29330176Bakland 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.
- Derived from this study: PubMed 29317417Pettersen 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.
- Derived from this study: PubMed 29259061Pettersen 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.
- Derived from this study: PubMed 28494809Mathisen 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.
- Norwegian School of Sports SciencesLink provided by the sponsor.
- The Norwegian Women's Public Health AssociationLink provided by the sponsor.
- University of TromsøLink provided by the sponsor.
- Modum BadLink provided by the sponsor.
- Recruitment webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorunn Sundgot-Borgen, Professor study chair
Norwegian School of Sport Sciences
Therese F Mathisen, PhDcandidate principal investigator
Norwegian School of Sport Sciences
Jan Rosenvinge, Professor study director
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Therapy and Physical Activity and Dietary Therapy in people with Bulimia Nervosa and Binge Eating Disorder, run by Norwegian School of Sport Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of treatment, evaluated through the change in symptoms of eating disorder (time frame: Pre-test in week 0, Post-tests (week 17), and at 6, 12, and 24 months after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079935, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.