Trial document




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  DRKS00013173

Trial Description

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Title

"Strengthening health promotion: enhanced check-up visits for mother and child"

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Trial Acronym

GeMuKi

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URL of the Trial

http://www.gemuki.de

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Brief Summary in Lay Language

Research indicates that women are at increased risk of overweight and obesity during pregnancy. To support these women and young parents, a complementary preventive consultation with gynecologists, midwives and paediatricians will be established in addition to the regular check-ups to provide additional information on topics such as nutrition and physical activity. So far, there are only few approaches in Germany for supplementary and interdisciplinary preventive counseling.
In the study, it will be assessed whether the preventive counseling has an effect. In study arm A participants receive a comprehensive consultation in addition to the standard care in the regular check-ups, both during pregnancy and after birth. In study arm B women receive standard care only. The study is randomized which means that the decision of allocation to study arm A or B, is taken with the lot. The evaluation of the study aims to show whether maternal lifestyle has changed positively in women in study arm A. In order to be able to compare the respective study arms, participants in both study arms fill in questionnaires. The questionnaires include questions on diet and physical activity, maternal well-being and health literacy (the ability to obtain, understand and use health information). Additionally, data of women in both study arms are entered in a data platform developed for the project, which are taken, inter alia, from the expectant mother's record of prenatal and natal care.
Women may participate in the study if they are between the 8th to the 12th week of gestation, are 18 years or older, are medically superviced by a gynecologist within one of the study regions, are health insured at one of the cooperating health insurers (AOK Baden-Württemberg, Techniker Krankenkasse, BARMER, GWQ ServicePlus), show no symptoms of depression and have sufficient skills of german language.
Within the framework of this study, telephone interviews as well as focus groups will be conducted with care givers, medical assistants and participants. In these interviews, supporting and hindering factors of the implementation of the intervention will be discussed.
The aim of this study is to introduce additional preventive counseling that improves the quality of care and minimizes the risk of overweight and obesity.

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Brief Summary in Scientific Language

Based on a successful model project in Baden-Wuerttemberg and a successful pilot study in Bavaria, the obstetric and pediatric medical check-ups are supplemented by preventive counseling to promote health literacy and reduce lifestyle-related obesity and obesity risks up to the child's first year of life.
The efficacy of GeMuKi is being tested in a cluster randomized controlled trial (summative evaluation). At the same time, supplementary data will be collected on the process of implementation (formative evaluation). The primary endpoint (patient-related) is the reduction in the proportion of pregnant women with excessive weight gain during pregnancy as recommended by the Institute of Medicine (IOM).

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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

  •   DRKS00013173
  •   2019/01/03
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  •   yes
  •   Approved
  •   18-163, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   The course of the study is related to the number of check-ups. Women in the intervention group receive preventive counseling during each preventive check-up. At each check-up, data such as the woman's weight development is entered into the online platform. Four preventive appointments take place with participating gynecologists, 3 with midwives 4 with paediatricians.

    Women have to complete questionnaires at the gynecologist two times, namely:
    a) in the 8th to the 12th week of pregnancy. Here also a short questionnaire will be filled in to determine if women meet the inclusion criteria
    b) at the 37th week of pregnancy

    At the pediatrician, questionnaires are completed at two times, namely:
    a) in the 3rd to 4th month after birth
    b) in the 12th month after birth
  •   The course of the study is related to the number of check-ups. Women in the control group receive the regular health care during each check-up. At each check-up, data such as the woman's weight development is entered into the online platform. Four preventive appointments take place with participating gynecologists, 3 with midwives 4 with paediatricians.

    Women have to complete questionnaires at the gynecologist two times, namely:
    a) in the 8th to the 12th week of pregnancy. Here also a short questionnaire will be filled in to determine if women meet the inclusion criteria
    b) at the 37th week of pregnancy

    At the pediatrician, questionnaires are completed at two times, namely:
    a) in the 3rd to 4th month after birth
    b) in the 12th month after birth
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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
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Reduction of the proportion of women experiencing excessive gestational weight gain during pregnancy. The data are collected at the regular check-ups (4 times) and entered by the gynecologist and / or medical assistant into a data platform specially developed for the project.

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Secondary Outcome

Patient-related: health literacy, maternal lifestyle and mental health are assessed based on the above-mentioned survey.

Pregnancy and childbirth complications and weight development of mother and child are assessed at each regular check-ups (4 with the gynecologists, 3 with midwives and 4 with pediatricians) using the data platform.

Effects on the use of health services is assessed by the continuous transmission of the routine data of the cooperating health insurances.

System-related: process of implementation of GeMuKi and supporting and hindering factors for implementation are assessed at the beginning and end of the project by means of focus groups with healthcare providers (gynecologists, pediatricians) and telephone interviews with midwives, MFAs and participating women of the intervention group.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/02/01
  •   2550
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- signed written informed consent form
- 18 years or older
- pregnant between 8th to 12th week of gestation
- medically supervised by a gynecologist in one of the 8 study regions in Baden-Württemberg
- health insured at one of the cooperating health insurers: AOK Baden-Württemberg, Techniker Krankenkasse, BARMER, GWQ ServicePlus
- no symptoms of depression (EPDS-Score ≤ 9, Item 10 < 3)
- sufficient skills of german language.

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Exclusion Criteria

Exclusion of participants because of pre-existing conditions or poor general state of health is at the discretion of the physician.

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Addresses

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    • Plattform Ernährung und Bewegung e.V. (peb)
    • Mr.  Dr.  Gerhard  Koch 
    • Wallstr. 65
    • 10179  Berlin
    • Germany
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    • Institut für Gesundheitsökonomie und Klinische Epidemiologie der Uniklinik Köln
    • Ms.  Prof. Dr. med.  Stephanie  Stock 
    • Gleueler Straße 176-178
    • 50935  Köln
    • Germany
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    • Plattform Ernährung und Bewegung e.V. (peb)
    • Ms.  Dr.  Anne-Madeleine  Bau 
    • Wallstr. 65
    • 10179  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim G-BA
    • Ms.  Dr.  Britta  Sommersberg 
    • Postfach 12 06 06
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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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.