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

March 11, 2019 updated by: Professor Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences

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

"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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0806
        • Norwegian School of Sports Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pretest (week 0), post-test (week 17) and at 6, 12 and 24 months after treatment
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)
Pre-test in week 0, Post-tests ( week 17), and at 6, 12 and 24 months after intervention.
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)
Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment
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)
Pre-test and post-test (week 17) and at 6,12,18 and 24 months post-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
Pre-test, in week 8 of treatment, post-test (week 17) and at 6,12,18 and 24 months post-treatment
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
Pre-test, week 8 of treatment, post-test (week 17) and at 6,12,18 and 24 months post-treatment
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.
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)
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
Pre-test in week 0, Post-test (week 17) and 6, 12, and 24 months post-treatment
Interview: measure and explore patients experienced treatment satisfaction and outcome/benefits with PED-t.
Time Frame: Post treatment

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
Interview: What are the theraphists experiences of their contribution to the PED-t program
Time Frame: Post treatment

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
Interview: What are the experiences of the participants who drop out of the PED-t program?
Time Frame: Post treatment
Data are analyzed in four steps within the framework of systematic text condensation (Malterud 2012).
Post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian School of Sport Sciences

Collaborators

University of Tromso
The Norwegian Women´s Public Health Association

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2014

Primary Completion (ACTUAL)

January 31, 2019

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/344
  • 2013/1871 (OTHER_GRANT: Regional Committees for Medical and Health Research Ethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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