Treatment of Eating Disorders by Physical Activity and Nutrition Counseling (FAKT)

"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.

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.

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.

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.

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)

Interview on the expectations the patients have to the specified treatment method of eating disorders (arm of intervention) EPDEX (Clinton 2001)

Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention), EPDEX (Clinton 2001)

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

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

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

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

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

Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

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

CPET: with the use of modified Balke Treadmill performance evaluation test, The Borg scale (Borg, 1982)

DXA (dual-energy x-ray absorptiometry) (weekly weight registration will also be kept in each arm of treatment)

Blood test to identify nutritional status of iron, folate, cholesterol and triglycerides, ApoA, ApoB and vitamin-D, folic acid

Blood test to evaluate hormonal status of estradiol, progesterone, CTX, P1nP, insulin, leptin, TSH, T3, T4, FSH, LH, cortisol

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)

Wearing a GT3X-BT actigraph accelerometer for 7 consecutive days and making notes on daily activity in 30 minutes intervals

Interview: measure and explore patients experienced treatment satisfaction and outcome/benefits with PED-t.

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. Data are analyzed in four steps within the framework of systematic text condensation (Malterud 2012).

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. Data are analyzed in four steps within the framework of systematic text condensation (Malterud 2012).

Data are analyzed in four steps within the framework of systematic text condensation (Malterud 2012).

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.