Clinical trial NCT02079935: Treatment of Eating Disorders by Physical Activity and Nutrition Counseling
Official title: Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Binge Eating Disorder
Keywords: BN
Binge
overconsumption of food
purging
purge
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: The Norwegian Women´s Public Health Association
name: University of Tromso
First posted: 2014-03-06
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
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.
Secondary outcomes:
measure: Expectations of treatment method for eating disorders
timeFrame: Pre-test
measure: Experiences of the treatment method for eating disorders
timeFrame: Post-test (week 17)
measure: Associated cost with treatment method
timeFrame: Pre-test
measure: Associated cost with treatment method
timeFrame: Post-test (week 17)
measure: Associated cost With treatment method
timeFrame: Post-test (by 6th month post-treatment)
measure: Associated cost With treatment method
timeFrame: Post-test (by 12th month post-treatment)
measure: Associated cost with treatment method
timeFrame: Post-test (by 24th month post-treatment)
measure: Global measurement of general psychopathology
timeFrame: Pre-treatment
measure: Global measurement of general psychopathology
timeFrame: Post-treatment (week 17)
measure: Global measurement of general psychopathology
timeFrame: Post-treatment (by the 6th month post-treatment)
measure: Global measurement of general psychopathology
timeFrame: Post-test (by 12th month post-treatment)
measure: Global measurement of general psychopathology
timeFrame: Post-test (by 24th month post-treatment)
measure: Group climate
timeFrame: week 1-16
measure: Working AIliance
timeFrame: week 1-16
measure: Experiences of the treatment method for eating disorders
timeFrame: Post-test (6 months)
measure: Experiences of the treatment method for eating disorders
timeFrame: Post-test (by 12th month post-treatment)
measure: Experiences of the treatment method for eating disorders
timeFrame: Post-test (by 24th month post-treatment)
measure: Change in eating disorder behavior and cognitions related to body figure and bodyweight
timeFrame: Week 1-16 during treatment
Other outcomes:
measure: Change in muscular strength
timeFrame: Pretest (week 0), post-test (week 17) and at 6, 12 and 24 months after treatment
measure: Change in cardiovascular endurance
timeFrame: Pre-test in week 0, Post-tests ( week 17), and at 6, 12 and 24 months after intervention.
measure: Change in bone mineral density
timeFrame: Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment
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
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
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
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)
measure: Change in physical activity level
timeFrame: Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment
measure: Interview: measure and explore patients experienced treatment satisfaction and outcome/benefits with PED-t.
timeFrame: Post treatment
measure: Interview: What are the theraphists experiences of their contribution to the PED-t program
timeFrame: Post treatment
measure: Interview: What are the experiences of the participants who drop out of the PED-t program?
timeFrame: Post treatment
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sports Sciences
Study officials:
affiliation: Norwegian School of Sports Sciences
name: Jorunn Sundgot-Borgen, Professor
role: STUDY_CHAIR
affiliation: Norwegian School of Sports Sciences
name: Therese F Mathisen, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tromso
name: Jan Rosenvinge, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.