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

N

Norwegian School of Sport Sciences

Status

Completed

Conditions

Bulimia Nervosa
Binge Eating Disorder

Treatments

Behavioral: Cognitive Behaviour Therapy
Behavioral: Physical Activity and Dietary Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02079935
2013/1871 (Other Grant/Funding Number)
2013/344

Details and patient eligibility

About

"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.

Full 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.

Enrollment

128 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

128 participants in 2 patient groups

Cognitive Behaviour Therapy
Experimental group
Description:
Treatment with small groups following a modified protocol first described by Fairburn 2008
Treatment:
Behavioral: Cognitive Behaviour Therapy
Physical activity and dietary therapy
Experimental group
Description:
Treatment with guided physical activity and dietary therapy in small groups
Treatment:
Behavioral: Physical Activity and Dietary Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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