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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02079935
First Posted: March 6, 2014
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 and Dietary Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Masking Description:
The one transferring results from lab's and questionaires to SPSS are blinded for group affiliation.
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 Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences:

Primary Outcome Measures:
  • Effectiveness of treatment, evaluated through the change in symptoms of eating disorder [ Time Frame: 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: 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 ]
    Interview on the expectations the patients have to the specified treatment method of eating disorders (arm of intervention) EPDEX (Clinton 2001)

  • Experiences of the treatment method for eating disorders [ Time Frame: Post-test (week 17) ]
    Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention), EPDEX (Clinton 2001)

  • Associated cost with treatment method [ Time Frame: Pre-test ]
    Calculation of the directly and indirectly cost related to treatment method

  • Associated cost with treatment method [ Time Frame: Post-test (week 17) ]
    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) ]
    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) ]
    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) ]
    Calculation of the directly and indirectly cost related to treatment method

  • Global measurement of general psychopathology [ Time Frame: Pre-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

  • Global measurement of general psychopathology [ Time Frame: Post-treatment (week 17) ]
    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

  • Global measurement of general psychopathology [ Time Frame: Post-treatment (by the 6th 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

  • Global measurement of general psychopathology [ Time Frame: Post-test (by 12th 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

  • Global measurement of general psychopathology [ Time Frame: 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

  • Group climate [ Time Frame: week 1-16 ]
    coerciveness scale from Therapeutic Factor Inventory (Lese & MacNair-Semands, 2000).

  • Working AIliance [ Time Frame: week 1-16 ]
    Working AIliance Inventory (Horwath & Greenberg, 1989)

  • Experiences of the treatment method for eating disorders [ Time Frame: Post-test (6 months) ]
    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) ]
    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) ]
    Interview on the experiences the patients have to the specified treatment method of eating disorders (arm of intervention) (Clinton 2001)

  • Change in eating disorder behavior and cognitions related to body figure and bodyweight [ Time Frame: 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


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 ]
    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 ( week 17), and at 6, 12 and 24 months after intervention. ]
    CPET: with the use of modified Balke Treadmill performance evaluation test, The Borg scale (Borg, 1982)

  • Change in bone mineral density [ Time Frame: Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment ]
    DXA (Dual-energy X-ray absorptiometry)

  • Change in body weight and bodycomposition [ Time Frame: Pre-test and post-test (week 17) and at 6,12,18 and 24 months post-treatment ]
    DXA (dual-energy x-ray absorptiometry) (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) and at 6,12,18 and 24 months post-treatment ]
    Blood test to identify nutritional status of iron, folate, cholesterol and triglycerides, ApoA, ApoB and vitamin-D, folic acid

  • Change in hormonal status [ Time Frame: Pre-test, week 8 of treatment, post-test (week 17) and at 6,12,18 and 24 months post-treatment ]
    Blood test to evaluate hormonal status of estradiol, progesterone, CTX, P1nP, insulin, leptin, TSH, T3, T4, FSH, LH, cortisol

  • Change in dietary and nutritional intake [ Time Frame: 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) ]
    24 hour recall interview: interview on the intake of food and beverage during the past 24 hours.

  • Change in physical activity level [ Time Frame: Pre-test in week 0, Post-test (week 17) and 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


Enrollment: 128
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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 Names:
  • CBT-ED
  • CBT-enhanced
  • CBT-e
Experimental: Physical activity and dietary therapy
Treatment with guided physical activity and dietary therapy in small groups
Behavioral: 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.
Other Names:
  • PADT
  • FAKT
  • PED-t

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079935


Locations
Norway
Norwegian School of Sports Sciences
Oslo, Norway, 0806
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 ( Other Grant/Funding Number: Regional Committees for Medical and Health Research Ethics )
First Submitted: February 17, 2014
First Posted: March 6, 2014
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences:
BN
Binge
overconsumption of food
purging
purge

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


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