Trial document




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  DRKS00017226

Trial Description

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Title

Behavioral and dietary intervention to reduce weight in adult overweight and obese kidney transplant recipients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

As in the general population, many kidney transplant patients are overweight or obese. It is known that overweight and obesity are responsible for a variety of diseases, such as diseases of the cardiovascular system (heart attack, stroke, hypertension), diabetes mellitus, and also tumors. In patients undergoing kidney transplantation, it is also known that overweight and obesity may adversely affect the function of the transplanted kidney.
It is known that even a weight loss of ≥5% of body weight has positive effects on the health of overweight or obese people.
The purpose of this study is to determine whether a weight loss of ≥5% can be realistically achieved and whether this affects the function of the kidney graft and related processes.
The planned study is a randomized controlled trial. The patients treated in the study, ie allocated to the intervention group, receive a behavioral and nutritional intervention. These are 12 appointments with a duration of 50 to 60 minutes, which should take place within six months.
The goal is to assist patients through weight loss sessions (≥5% of body weight). The study covers a total of 18 months. At scheduled times, the study will investigate at baseline, 6, 12 and 18 months.
The participants in the control group receive one-time information about healthy nutrition after kidney transplantation. In addition, they will be asked to attend the follow-up examinations described above after 6, 12 and 18 months.

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Brief Summary in Scientific Language

There is solid evidence that kidney transplant patients are susceptible to gain weight after transplantation and that posttransplantation overweight (25<BMI<30) and obesity (BMI≥30 kg/m2) are associated with higher risk of mortality and graft failure as well as higher risks of hypertension, dyslipidemia, diabetes mellitus, and cardiovascular events, which are still the leading cause of mortality after transplantation. In a randomized-controlled trial a 6-month behavioral and dietary intervention will be compared to usual care in adult patients after renal transplantation. The main outcome will be the percentage of participants reaching a weight loss of ≥ 5%, which is not only a realistic and sustainable weight loss goal but also sufficient to significantly improve metabolic and immunological parameters according to the German S3-guideline “Obesity–Prevention and Treatment”. The intervention will consist of 12 individual sessions either conducted face-to-face or via videoconferencing. Sustainability/maintenance of weight loss will be investigated 12 and 18 months after randomization.
We hypothesize that after a 6-month intervention 55% of the participants of the intervention group (IG) will have reached a weight loss of ≥5% in comparison to 15% in the control group (CG). Power analysis revealed a required sample size of 56 patients with 28 patients in each group.

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Organizational Data

  •   DRKS00017226
  •   2019/04/30
  •   [---]*
  •   yes
  •   Approved
  •   8341_BO_S_2019, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  •   U1111-1232-4269 
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Health Condition or Problem studied

  •   Z94.0 -  Kidney transplant status
  •   E66.0 -  Obesity due to excess calories
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Interventions/Observational Groups

  •   intervention group: 12 sessions of behavioral and dietary Intervention (over the course of six month)
  •   control group: one-time information
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

weight loss ≥5% of body weight (after six month)

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Secondary Outcome

Extent of weight loss in kg, Change in the waist circumference, Alteration of renal function parameters, Changes in metabolic and immunological parameters, Change in obesity-specific quality of life, Sustainability of weight loss (baseline, 6, 12 and 18 month)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/05/01
  •   56
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

BMI between 27 and 40 kg / m2, sufficient German language skills, informed consent to participate in this study, stable kidney transplant function

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Exclusion Criteria

BMI below 27 kg / m2 or above 40 kg / m2, insufficient knowledge of the German language, lack of ability to consent, severe cognitive impairment (DemTect ≤ 8 points), unstable kidney transplant function, pregnancy

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Addresses

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    • Medizinische Hochschule Hannover, Klinik für Psychosomatik und Psychotherapie
    • Ms.  Dr. med.  Mariel  Nöhre 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Klinik für Psychosomatik und Psychotherapie
    • Ms.  Prof. Dr. med.  Martina  de Zwaan 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Klinik für Nieren- und Hochdruckerkrankungen
    • Ms.  Prof. Dr. med.  Faikah  Güler 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Institut für Sportmedizin
    • Ms.  Dr. med.  Elisabeth  Schieffer 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Klinik für Psychosomatik und Psychotherapie
    • Ms.  Dr. med.  Mariel  Nöhre 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover, Klinik für Psychosomatik und Psychotherapie
    • Ms.  Dr. med.  Mariel  Nöhre 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Hochschule Hannover
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.