Treatment of Eating Disorders by Physical Activity and Nutrition Counseling

Bulimia Nervosa Clinical Trial

— FAKT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079935
• Other study ID #: 2013/344
• Secondary ID: 2013/1871
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2019
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Feeding and Eating Disorders

Intervention

Behavioral:
• Cognitive Behaviour Therapy
Following group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway.
• Physical Activity and Dietary Therapy
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.

Locations

Country	Name	City	State
Norway	Norwegian School of Sports Sciences	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences	The Norwegian Women´s Public Health Association, University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in muscular strength	Status of 1 repetition maximum, 1RM, muscular strength in squats, bench press and seated row	Pretest (week 0), post-test (week 17) and at 6, 12 and 24 months after treatment
Other	Change in cardiovascular endurance	CPET: with the use of modified Balke Treadmill performance evaluation test, The Borg scale (Borg, 1982)	Pre-test in week 0, Post-tests ( week 17), and at 6, 12 and 24 months after intervention.
Other	Change in bone mineral density	DXA (Dual-energy X-ray absorptiometry)	Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment
Other	Change in body weight and bodycomposition	DXA (dual-energy x-ray absorptiometry) (weekly weight registration will also be kept in each arm of treatment)	Pre-test and post-test (week 17) and at 6,12,18 and 24 months post-treatment
Other	Change in nutritional status	Blood test to identify nutritional status of iron, folate, cholesterol and triglycerides, ApoA, ApoB and vitamin-D, folic acid	Pre-test, in week 8 of treatment, post-test (week 17) and at 6,12,18 and 24 months post-treatment
Other	Change in hormonal status	Blood test to evaluate hormonal status of estradiol, progesterone, CTX, P1nP, insulin, leptin, TSH, T3, T4, FSH, LH, cortisol	Pre-test, week 8 of treatment, post-test (week 17) and at 6,12,18 and 24 months post-treatment
Other	Change in dietary and nutritional intake	24 hour recall interview: interview on the intake of food and beverage during the past 24 hours.	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)
Other	Change in physical activity level	Wearing a GT3X-BT actigraph accelerometer for 7 consecutive days and making notes on daily activity in 30 minutes intervals	Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment
Other	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).	Post treatment
Other	Interview: What are the theraphists experiences of their contribution to the PED-t program	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).	Post treatment
Other	Interview: What are the experiences of the participants who drop out of the PED-t program?	Data are analyzed in four steps within the framework of systematic text condensation (Malterud 2012).	Post treatment
Primary	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	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
Secondary	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)
Secondary	Associated cost with treatment method	Calculation of the directly and indirectly cost related to treatment method	Pre-test
Secondary	Associated cost with treatment method	Calculation of the directly and indirectly cost related to treatment method	Post-test (week 17)
Secondary	Associated cost With treatment method	Calculation of the directly and indirectly cost related to treatment method	Post-test (by 6th month post-treatment)
Secondary	Associated cost With treatment method	Calculation of the directly and indirectly cost related to treatment method	Post-test (by 12th month post-treatment)
Secondary	Associated cost with treatment method	Calculation of the directly and indirectly cost related to treatment method	Post-test (by 24th month post-treatment)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Group climate	coerciveness scale from Therapeutic Factor Inventory (Lese & MacNair-Semands, 2000).	week 1-16
Secondary	Working AIliance	Working AIliance Inventory (Horwath & Greenberg, 1989)	week 1-16
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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

External Links

•   Modum Bad
•   Norwegian School of Sports Sciences
•   Recruitment webpage
•   The Norwegian Women's Public Health Association
•   University of Tromsø