Treatment of Eating Disorders by Physical Activity and Nutrition Counseling

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study

Conditions
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Bulimia Nervosa, Binge Eating Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behaviour Therapy
* Behavioral: Physical Activity and Dietary Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behaviour Therapy<br>Treatment with small groups following a modified protocol first described by Fairburn 2008 | Behavioral: Cognitive Behaviour Therapy<br>* Following group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway.<br>* Other names: CBT-e;|
| Experimental: Physical activity and dietary therapy<br>Treatment with guided physical activity and dietary therapy in small groups | Behavioral: Physical Activity and Dietary Therapy<br>* 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.<br>* Other names: PED-t;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Post-test (week 17) | 
| Associated cost with treatment method | Calculation of the directly and indirectly cost related to treatment method | Pre-test | 
| Associated cost with treatment method | Calculation of the directly and indirectly cost related to treatment method | Post-test (week 17) | 
| Associated cost With treatment method | Calculation of the directly and indirectly cost related to treatment method | Post-test (by 6th month post-treatment) | 
| Associated cost With treatment method | Calculation of the directly and indirectly cost related to treatment method | Post-test (by 12th month post-treatment) | 
| Associated cost with treatment method | Calculation of the directly and indirectly cost related to treatment method | 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 | 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 | 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 | 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 | 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 | Post-test (by 24th month post-treatment) | 
| Group climate | coerciveness scale from Therapeutic Factor Inventory (Lese & MacNair-Semands, 2000). | week 1-16 | 
| Working AIliance | Working AIliance Inventory (Horwath & Greenberg, 1989) | 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) | 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) | 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) | 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 | Week 1-16 during treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge, overconsumption of food, purging, purge, BN