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Completed

NCT Number: NCT02079935

Treatment of Eating Disorders by Physical Activity and Nutrition Counseling

"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.

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Key information

Conditions

Bulimia Nervosa Binge Eating Disorder Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian School of Sports Sciences

Oslo, 0806, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behaviour Therapy

Behavioral

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

Physical Activity and Dietary Therapy

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. Associated cost with treatment method

    Time frame: Pre-test

    Calculation of the directly and indirectly cost related to treatment method

  4. Associated cost with treatment method

    Time frame: Post-test (week 17)

    Calculation of the directly and indirectly cost related to treatment method

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. Group climate

    Time frame: week 1-16

    coerciveness scale from Therapeutic Factor Inventory (Lese & MacNair-Semands, 2000).

  14. Working AIliance

    Time frame: week 1-16

    Working AIliance Inventory (Horwath & Greenberg, 1989)

  15. 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)

  16. 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)

  17. 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)

  18. 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 outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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).

  10. 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).

  11. 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).

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Collaborators

  • The Norwegian Women´s Public Health Association
  • University of Tromso

Registry information

Official study title

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

Acronym: FAKT

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2014
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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