Trial document




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  DRKS00017220

Trial Description

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Title

Effectiveness of a self-help approach (Imaginal Retraining) to reduce problematic eating behaviour

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Trial Acronym

Imaginal Retraining

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URL of the Trial

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Brief Summary in Lay Language

The aim of the present study is to investigate the acceptance and efficacy of a self-help approach to reduce problematic eating behaviour in a sample of individuals with overweight and obesity. We expect that the treatment group will show a greater reduction of problematic eating behaviour compared to a wait-list control group (with care as usual (CAU); parallel interventions may be continued). At total of 100 people wishing to reduce their problematic eating behaviour (e.g. craving for high-calorie food) are randomly assigned to two groups (treatment group or wait-list control group). In order to assess a change in symptoms, various self-assessment questionnaires are administered before and after the intervention (four weeks).

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Brief Summary in Scientific Language

Problematic eating behaviour is accompanied by serious health problems and thus leads to high economic costs. The aim of the present study is to investigate the acceptance and efficacy of a self-help manual targeting problematic eating behaviour in a sample of participants wishing to improve their eating behaviour. The treatment manual is based on the so-called Retraining approach, which is tested in an imaginal version. We assume that the intervention group shows a greater reduction in problematic eating behaviour and urge to eat unhealthy or high-calorie food compared to a wait-list control group (with CAU). A total of 100 persons with over-weight or obesity are randomly assigned to either the intervention group or to a wait-list control group. After 6 weeks all participants will be invited for a post-assessment. The primary outcome are items assessing the reduction of food craving taken from the Food Craving Questionnaire (FCQ).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017220
  •   2019/05/03
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  •   yes
  •   Approved
  •   LPEK-0030, Lokale Psychologische Ethikkommission (LPEK) am Zentrum für Psychosoziale Medizin des UKE
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Secondary IDs

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Health Condition or Problem studied

  •   E66 -  Obesity
  •   F50.9 -  Eating disorder, unspecified
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Interventions/Observational Groups

  •   Interventional = Self-help intervention (imaginal retraining) for individuals with overweight or obesity over a period of 6 week, which is sent as a PDF file by e-mail
  •   Wait-list control group = no additional treatment during the intervention period of 6 weeks (but may continue previously initiated treatment, CAU); receives access to treatment manual after completion of the post-assessment
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Items assessing the reduction of food craving, taken from the food craving questionnaire (FCQ) with a five-point Likert-type scale (at baseline- and post-assessment)

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Secondary Outcome

Beck Depression Inventory II (BDI-II): Self-rating questionnaire measuring depressive symptoms during the last two weeks (at baseline- and post-assessment); Patient Health Questionnaire-9 (PHQ-9): Self-rating questionnaire measuring depressive symptoms during the past week (at baseline- and post-assessment); Visual Analogue Scale (VAS) measuring craving: Visual Analogue Scale assessing the craving for high-calorie food over the last week (at baseline- and post-assessment); Three-Factor Eating Questionnaire (TFEQ): Questionnaire assessing three components of eating behaviour on three subscales (cognitive restraint of eating, disinhibition, hunger), registration of the body weight (at baseline- and post-assessment); Quality of life (WHO-QOL-BREF): Questionnaire that measures the quality of life in the last two weeks (at baseline- and post-assessment); Generalized Anxiety Disorder 7 (GAD-7): Self-rating questionnaire to assess the general anxiety level over the last two weeks (at baseline- and post-assessment); University of Rhode Island Change Assessment Scale (URICA): Self-report questionnaire that assesses moderators of change (at baseline-assessment only); Credibility/Expectancy Questionnaire (CEQ): One item that measures treatment expectations (at baseline-assessment); Questionnaire on patient satisfaction in modified version (ZUF-8): Self-report questionnaire that measures the global patient satisfaction at the end of treatment (at post-assessment).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/05/12
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

consent to participate in study (informed consent); internet access; sufficient command of the German language; willingness to participate in two anonymous online surveys, each of which lasts approx. 25-30 minutes; willingness to participate in a 6-week training program; willingness to use the program on one's own responsibility; willingness to provide an e-mail address

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Exclusion Criteria

lifetime schizophrenia; acute suicidal tendencies; BMI < 25; eating disorders (anorexia nevorsa or bulimia nervosa) in the past (binge eating disorder does not lead to exclusion exclusion); performing other diets

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Arbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Arbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Arbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Arbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr.  Steffen  Moritz 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/07/24
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Trial Publications, Results and other Documents

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