Treatment of Eating Disorders by Physical Activity and Nutrition Counseling
- Conditions
- Binge Eating DisorderBulimia Nervosa
- Interventions
- Behavioral: Cognitive Behaviour TherapyBehavioral: Physical Activity and Dietary Therapy
- Registration Number
- NCT02079935
- Lead Sponsor
- Norwegian School of Sport Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 128
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Behaviour Therapy Cognitive Behaviour Therapy Treatment with small groups following a modified protocol first described by Fairburn 2008 Physical activity and dietary therapy Physical Activity and Dietary Therapy Treatment with guided physical activity and dietary therapy in small groups
- Primary Outcome Measures
Name Time Method Effectiveness of treatment, evaluated through the change in symptoms of eating disorder 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)
- Secondary Outcome Measures
Name Time Method Experiences of the treatment method for eating disorders Post-test (by 24th month post-treatment) Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)
Group climate week 1-16 coerciveness scale from Therapeutic Factor Inventory (Lese \& MacNair-Semands, 2000).
Expectations of treatment method for eating disorders Pre-test Interview on the expectations the patients have to the specified treatment method of eating disorders (arm of intervention) EPDEX (Clinton 2001)
Associated cost with treatment method Post-test (by 24th month post-treatment) Calculation of the directly and indirectly cost related to treatment method
Working AIliance week 1-16 Working AIliance Inventory (Horwath \& Greenberg, 1989)
Associated cost With treatment method Post-test (by 12th month post-treatment) Calculation of the directly and indirectly cost related to treatment method
Change in eating disorder behavior and cognitions related to body figure and bodyweight Week 1-16 during treatment 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
Global measurement of general psychopathology Post-test (by 24th month post-treatment) 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
Trial Locations
- Locations (1)
Norwegian School of Sports Sciences
🇳🇴Oslo, Norway