Trial document





This trial has been registered retrospectively.
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  DRKS00007702

Trial Description

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Title

Obesity prevention through familiy based intervention combining physical activity and nutrition counselling

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Trial Acronym

ADEBAR

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URL of the Trial

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Brief Summary in Lay Language

The relationship between lifestyle of expectant mothers/fathers and child development is becoming the center of scientific interest and perinatal programming is becoming subject of scientific research and research efforts. Up to know, there are rarely no obvious and convincing scientific conclusions especially in the context of physical activity and nutrition of mothers and fathers on the development of the child.
Therefore, the aim of this study is to evaluate the effect of a multicomponent, family based program during pregnancy on children’s outcome after 24 month of life.
The program will be a combination of structured physical activity classes twice a week for 90 minutes each and nutrition counseling (6 times for at least 60 minutes) during pregnancy over a period of 8 month. Maternal fasten blood samples as well as anthropometric measurements (height, weight, circumferences, blood pressure, skinfold thickness) will be taken at seven time points during intervention (8 weeks of gestation, 14 weeks of gestation, 24 weeks of gestation, 36 weeks of gestation, birth, 8 weeks postpartum, 2 years postpartum). Parental fasten blood samples will be taken at the beginning of the intervention, 8 weeks and 2 years postpartum. In addition umbilical cord blood samples will be collected from the placental part of the umbilical cord immediately after clamping. 8 weeks after birth parents will be invited for a finale meeting to document data on course of labor, current weight of family members and overall behavior. Biannually, parents will be contacted to analyze feeding routine, weight gain of the child and weight status of the parents.

Women with a pre-pregnancy body-mass-index (BMI) ≥ 25kg/m2, gestational age between 6 and 8 weeks of gestation who were previously sedentary, with a singleton pregnancy and without pre-existing conditions such as heart disease, not currently using alcohol and mediation for mental health disorders will be recruited.

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Brief Summary in Scientific Language

Findings from the largest nationally and internationally representative studies have shown that the number of overweight (BMI ≥ 25,0 kg/m2) and obese adults (BMI ≥ 30,0 kg/m2) is increasing. Over the past two decades, in particular, the number of obese German women in younger age groups (up to 35) has increased. Evidence has been presented for links between overweight/obesity and a variety of co-morbidities during pregnancy such as gestational diabetes. It is particularly noticeable that overweight and obese women gain much more weight during pregnancy than normal-weight women. Excessive weight gain during pregnancy is associated with multiple maternal and neonatal complications and seems to be one of the most important risk factors for obesity in later life.
Furthermore, the so called fetal overfeeding seems to play an important role in the development of overweight and obesity in childhood. Based on the Barker hypothesis, new researches assume that maternal lifestyle might influence the metabolic, proinflammatoric and neurotrophic patterns of the unborn child. Besides insulin, adipokines such as leptin, resistin and adiponectin as well as selected cytokines such as TNFalpha and Interleukin 6 (IL-6) and maybe also Brain Derived Neurotrophic Factor (BDNF) are discussed as potential mediators. Visceral fat mass secrets most of these factors.
Besides maternal lifestyle factors paternal overweight is discussed in the context of juvenile obesity and is becoming subject of scientific research.
Therefore, the aim of this multicenter two-arm randomized controlled trial is to evaluate the effect of a multicomponent, family based program during pregnancy on maternal, paternal and fetal biomarkers and how lifestyle-related changes in the fetal environment might influence children’s outcome after 24 month of life.
The program will be a combination of structured physical activity classes twice a week for 90 minutes each and nutrition counseling (6 times for at least 60 minutes) during pregnancy over a period of 8 month. Maternal fasten blood samples as well as anthropometric measurements (height, weight, circumferences, blood pressure, skinfold thickness) will be taken at seven time points during intervention (8 weeks of gestation, 14 weeks of gestation, 24 weeks of gestation, 36 weeks of gestation, birth, 8 weeks postpartum, 2 years postpartum). Parental fasten blood samples will be taken at the beginning of the intervention, 8 weeks and 2 years postpartum. In addition umbilical cord blood samples will be collected from the placental part of the umbilical cord immediately after clamping. 8 weeks after birth parents will be invited for a finale meeting to document data on course of labor, current weight of family members and overall behavior. Biannually, parents will be contacted to analyze feeding routine, weight gain of the child and weight status of the parents.

Women with a pre-pregnancy body-mass-index (BMI) ≥ 25kg/m2, gestational age between 6 and 8 weeks of gestation who were previously sedentary, with a singleton pregnancy and without pre-existing conditions such as heart disease, not currently using alcohol and mediation for mental health disorders will be recruited.

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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

  •   DRKS00007702
  •   2016/08/10
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  •   no
  •   Approved
  •   087/15, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   E66.8 -  Other obesity
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Interventions/Observational Groups

  •   intervention:
    The intervention is a combination of specific physical activity training (46 units, each 90 minutes) and nutrition counselling (6 units, each 60 minutes) over a period of 8 months (9 weeks of gestation till 38 weeks of gestation):

    physical activity training (beginning at 13 weeks of gestation) consist of aerobic exercise (walking) once a week and strenght training (elastic bands) once a week.
    Every session will consist of 10 minutes measuring resting blood pressure before beginning, 10-15 minutes gradually warm-up and 10-15 minutes cool-down including low intensity calisthenics, relaxation and stretching (avoiding muscle pain) of most muscle groups (upper and lower limbs, shoulder and trunk) and 10 minutes pelvic floor exercise as described and recommended by the Canadian Society for Exercise Physiology (CSEP 2015). The main part of the session will last 40 minutes. Depending on women’s condition, the main part can be split up in two to three parts of 20 or 15 minutes respectively, with a little break between the parts to avoid physical overload. The duration of the parts may be gradually increased, as intervention progress.
    Aerobic exercise sessions will consist of walking. Each woman will wear a portable heart rate monitor and heart rate will be monitored throughout every session to confirm the heart rate recommended by Davenport et al. Furthermore, the talk test will be used to ensure that exercise takes place at a comfortable intensity.
    Strength training will consist of exercises targeting major muscles groups in the upper body, trunk and lower body by using resistance bands. In total, the participants will practice 8-10 muscular strength exercises with 12-15 repetitions per exercise for two to three sets. Workload and exercises will be documented on an exercise sheet for each woman. The intensity of the exercises will be set according to each woman’s perceived effort using Borg scale.

    Nutrition counselling (beginning at 9 weeks of gestation):
    Pregnant women and their partners will be invited to a lecture of healthy eating during pregnancy at 8 weeks of gestation. Following up this lecture a 24h dietary recall will be used to analyze individual energy intake. Based on this data, individual dietary counseling for the mother and if possible for the father will take place at 10 to 12 weeks of gestation. This individual counseling will be repeated at 16 and 24 weeks of gestation based on further 24h dietary recalls. Additionally, group dietary counseling will take place. Each session will last 60 minutes and will be led by a specifically trained ecotrophologist.
  •   control
    Women allocated to the control group will be neither encouraged nor discouraged from exercising. They will underwent normal antenatal care and receive usual nutrition and activity guidelines from their gynecologists. To improve compliance, participants from the control group will participate in a relaxing class, which includes breathing techniques and guided meditation once a week. The control group will do the same assessments (blood samples, antropometric measuments) as the intervention group.
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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

Rapid weight gain during the first month of life seems to be a predicator of overweight and obesity in adulthood. Therefore, primary outcome of this study is the BMI of the child after two years, assessed by German percentile (Kromeyer-Hauschild et al. 2001).childrens BMI after two years, calculated by kg/m2 and classified according to German percentiles for children (Kromeyer-Hauschild et al. 2001)

According to Robert-Koch-Institute, normal weight gain (50th percentile) after subtraction of birth weight is nine kilogram at the age of 24 month. BMI (body weight divided by the square of height in meters) shows a difference of 1 kg/m2 at this time point (50th percentile). Therefore, a difference of 1 kg/m2 at the age of two years between intervention and control group will be assumed.

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Secondary Outcome

Secondary outcomes will be assessed during pregnancy and post partum and will include:
- Course of pregnancy (weight gain according to IOM recommendation, avoidance of pregnancy-induced diseases and comorbidities, mode of delivery)
- Anthropometric data and health status of new-born (birth weight, length, head circumference, pH Value, Apgar score)
- Fetal biomarker of cord blood (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6)
- Maternal biomarker (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6) during and after pregnancy - 8th, 14th, 24th, 36th week of gestation and after intervention (labor, 8 weeks post partum, 12 month post partum, 24 month postpartum).
- Paternal biomarker (insulin, leptin, adiponectin, resistin, BDNF, TNF alpha, IL-6) - 8th week of women’s gestation and after intervention (8 weeks post partum, 24 month post partum)
- Child development (age appropriate development of fine and gross motor skills, communication, personal-social skills unsing ASQ-3) at 6 month, 12 month, 18 month, 24 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/06/21
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

female, pregnant (<10 week of gestation), BMI>25 kg/m2, ability to speak german, no contraindication for physical activity during pregnancy accroding to ACOG 2015, no drug use which influences body weight, previously inactiv, written consent for participation and blood collection

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Exclusion Criteria

<18 years of age, >10. week of gestation, multiple pregnancy, not speaking german sufficiently, contraindication for physical activity during pregnancy according to ACOG 2015, drug use which influences body weight

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Addresses

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    • Marga und Walter Boll-Stiftung
    • Marie-Curie-Str. 8
    • 50170  Kerpen
    • Germany
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    • Kölner Zentrum für Prävention im Kindes- und Jugendalter am Herzzentrum der Uniklinik Köln
    • Ms.  Dr.  Nina  Ferrari 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Kölner Zentrum für Prävention im Kindes- und Jugendalter am Herzzentrum der Uniklinik Köln
    • Ms.  Dr.  Nina  Ferrari 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Marga und Walter Boll-Stiftung
    • Marie-Curie-Str. 8
    • 50170  Kerpen
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Bewegungs- und Neurowissenschaft/Abt. III
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    •   022149825290
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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