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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Norwegian School of Sport Sciences
Sponsor:
Collaborators:
The Norwegian Women's Public Health Association
University of Tromso
Information provided by (Responsible Party):
Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier:
NCT02079935
First received: February 17, 2014
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

"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 activity and nutritional education 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.


Condition Intervention
Bulimia Nervosa
Binge Eating Disorder
Behavioral: Cognitive Behaviour Therapy
Behavioral: Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Eating Disorders - a Randomised, Controlled, Prospective Study

Resource links provided by NLM:


Further study details as provided by Norwegian School of Sport Sciences:

Primary Outcome Measures:
  • Effectiveness of treatment, evaluated through the change in eating disorder symptoms [ Time Frame: Pre-test in week 0, Post-tests are planned at week 17, and at 6, 12, and 24 months after intervention. ] [ Designated as safety issue: Yes ]
    Change in ED-symptoms are evaluated through screening and surveys: Eating disorder examination (EDE), 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:
  • Expectations of treatment method for eating disorders [ Time Frame: Pre-test ] [ Designated as safety issue: No ]
    Interview on the expectations the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

  • Experiences of the treatment method for eating disorders [ Time Frame: Post-test (week 17) ] [ Designated as safety issue: No ]
    Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

  • Associated cost with treatment method [ Time Frame: Pre-test ] [ Designated as safety issue: No ]
    Calculation of the directly and indirectly cost related to treatment method

  • Associated cost with treatment method [ Time Frame: Post-test (week 17) ] [ Designated as safety issue: No ]
    Calculation of the directly and indirectly cost related to treatment method

  • Associated cost With treatment method [ Time Frame: Post-test (by 6th month post-treatment) ] [ Designated as safety issue: No ]
    Calculation of the directly and indirectly cost related to treatment method

  • Associated cost With treatment method [ Time Frame: Post-test (by 12th month post-treatment) ] [ Designated as safety issue: No ]
    Calculation of the directly and indirectly cost related to treatment method

  • Associated cost with treatment method [ Time Frame: Post-test (by 24th month post-treatment) ] [ Designated as safety issue: No ]
    Calculation of the directly and indirectly cost related to treatment method

  • Global measurement of change in general psychopathology [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]
    Beck's Anxiety Inventory, Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale, QoL (Diener), SF-36, Utrecht Coping List, Resilience Scale for Adults

  • Global measurement of general psychopathology [ Time Frame: Post-treatment (week 17) ] [ Designated as safety issue: No ]
    Beck's Anxiety Inventory, Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale, QoL (Diener), SF-36, Utrecht Coping List, Resilience Scale for Adults

  • Global measurement of general psychopathology [ Time Frame: Post-treatment (by the 6th month post-treatment) ] [ Designated as safety issue: No ]
    Beck's Anxiety Inventory, Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale, QoL (Diener), SF-36, Utrecht Coping List, Resilience Scale for Adults

  • Global measurement of general psychopathology [ Time Frame: Post-test (by 12th month post-treatment) ] [ Designated as safety issue: No ]
    Beck's Anxiety Inventory, Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale, QoL (Diener), SF-36, Utrecht Coping List, Resilience Scale for Adults

  • Global measurement of general psychopathology [ Time Frame: Post-test (by 24th month post-treatment) ] [ Designated as safety issue: No ]
    Beck's Anxiety Inventory, Beck Depression Inventory (BDI), Hospital Anxiety and Depression Scale, QoL (Diener), SF-36, Utrecht Coping List, Resilience Scale for Adults

  • Group climate [ Time Frame: week 1-16 ] [ Designated as safety issue: No ]
    coerciveness scale from Therapeutic Factor Inventory (Lese & MacNair-Semands, 2000).

  • Working AIliance [ Time Frame: week 1-16 ] [ Designated as safety issue: No ]
    Working AIliance Inventory (Horwath & Greenberg, 1989)

  • Experiences of the treatment method for eating disorders [ Time Frame: Post-test (6 months) ] [ Designated as safety issue: No ]
    Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

  • Experiences of the treatment method for eating disorders [ Time Frame: Post-test (by 12th month post-treatment) ] [ Designated as safety issue: No ]
    Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

  • Experiences of the treatment method for eating disorders [ Time Frame: Post-test (by 24th month post-treatment) ] [ Designated as safety issue: No ]
    Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)


Other Outcome Measures:
  • Change in muscular strength [ Time Frame: Pretest (week 0), post-test (week 17) and at 6, 12 and 24 months after treatment ] [ Designated as safety issue: No ]
    Status of 1 repetition maximum, 1RM, muscular strength in squats, bench press and seated row

  • Change in cardiovascular endurance [ Time Frame: Pre-test in week 0, Post-tests are planned at week 17, and at 6, 12 and 24 months after intervention. ] [ Designated as safety issue: No ]
    The Balke Treadmill performance evaluation test, The Borg scale (Borg, 1982)

  • Change in Reason for exercise [ Time Frame: Pre-test in week 0, Post-tests are planned at week 17, and at 6, 12 and 24 months after intervention. ] [ Designated as safety issue: No ]
    Exercise dependence scale, Compulsive Exercise test

  • Change in bone mineral density [ Time Frame: Pre-test in week 0, Post-test are planned at week 17, and 6, 12, and 24 months post-treatment ] [ Designated as safety issue: No ]
    DXA (Dual-energy X-ray absorptiometry)

  • Change in body weight [ Time Frame: Pre-test, in week 8 of treatment, and post-test (week 17, and at 6,12,18 and 24 months post-treatment) ] [ Designated as safety issue: No ]
    Tanita scale (weekly weight registration will also be kept in each arm of treatment)

  • Change in nutritional status [ Time Frame: Pre-test, in week 8 of treatment, post-test (week 17) ] [ Designated as safety issue: No ]
    Blood test to identify nutritional status of iron, folate, cholesterol and triglycerides, and vitamin-D

  • Change in hormonal status [ Time Frame: Pre-test, week 8 of treatment, post-test (week 17) ] [ Designated as safety issue: No ]
    Blood test to evaluate hormonal status of estradiol, progesterone, CTX, P1nP and leptin

  • Change in nutritional intake [ Time Frame: Pre-test, each 3rd week in treatment, post-test at 17.th week, and post-treatment (6,12, and 24 months post-treatment) ] [ Designated as safety issue: No ]
    24 hour recall interview: interview on the intake of food and beverage during the past 24 hours.


Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behaviour Therapy
Treatment with small groups following a modified protocol first described by Fairburn 2008
Behavioral: Cognitive Behaviour Therapy
Following group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway.
Other Name: CBT-ED
Experimental: Physical activity

Physical activity and nutrition counseling:

Treatment with guided physical activity and nutrition counseling in small groups

Behavioral: Physical Activity
Guided physical activity and nutrition education, to improve healthy lifestyle and help stabilizing a healthy weight. To further strengthen selfimage through positive experiences, to improve mood through endorphins and stress relief in exercise
Other Names:
  • PANT
  • FAKT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women,
  • BMI 17,5-35,
  • Age of 18-35 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 >35 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079935

Contacts
Contact: Therese F Mathisen, PhDcandidate 95752818 ext +47 t.f.mathisen@nih.no
Contact: Jorunn Sundgot-Borgen, Professor 92241745 ext +47 jorunn.sundgot-borgen@nih.no

Locations
Norway
Norwegian School of Sports Sciences Recruiting
Oslo, Norway, 0806
Contact: Jorunn Sundgot-Borgen, Professor    922 41 745 ext +47    jorunn.sundgot-borgen@nih.no   
Principal Investigator: Therese F Mathisen, PhDcandidate         
Sponsors and Collaborators
Norwegian School of Sport Sciences
The Norwegian Women's Public Health Association
University of Tromso
Investigators
Study Chair: Jorunn Sundgot-Borgen, Professor Norwegian School of Sports Sciences
Principal Investigator: Therese F Mathisen, PhDcandidate Norwegian School of Sports Sciences
Study Director: Jan Rosenvinge, Professor University of Tromso
  More Information

Additional Information:
Publications:
Responsible Party: Professor Jorunn Sundgot-Borgen, Professor, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT02079935     History of Changes
Other Study ID Numbers: 2013/344, 2013/1871
Study First Received: February 17, 2014
Last Updated: July 2, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian School of Sport Sciences:
BN
Binge
overconsumption of food
purging
purge

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014