<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989142</url>
  </required_header>
  <id_info>
    <org_study_id>T005116N</org_study_id>
    <nct_id>NCT02989142</nct_id>
  </id_info>
  <brief_title>Inter-pregnAncy Coaching for a Healthy fuTure</brief_title>
  <acronym>inter-act</acronym>
  <official_title>Inter-pregnAncy Coaching for a Healthy fuTure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UC Leuven-Limburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project focuses on prevention of major pregnancy and birth related complications :&#xD;
      pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section&#xD;
      (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90%&#xD;
      percentile of birth weights for the specific pregnancy duration.&#xD;
&#xD;
      The investigators focus on the pre-conception period, i.e. the pre-conception period of the&#xD;
      2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to&#xD;
      decrease the complications rate in their 2nd pregnancy.&#xD;
&#xD;
      Women with an excessive gestational weight gain have obtained the extra weight during a&#xD;
      rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy. This&#xD;
      characteristic distinguishes the target group from the general population with&#xD;
      overweight/obesity, in whom the extra weight was acquired during many years and independent&#xD;
      from a pregnancy, making a behaviour change more complex.&#xD;
&#xD;
      The coaching intervention combines face-to-face counselling with the use of a mobile App&#xD;
      connected to medical devices (scale and pedometer). The app monitors important indicators&#xD;
      (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through&#xD;
      established behavioral change techniques, and is specifically tailored for women with&#xD;
      excessive weight gain during the previous pregnancy.&#xD;
&#xD;
      The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next&#xD;
      pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained&#xD;
      during the next pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim is to decrease the prevalence of pregnancy and birth-related complications&#xD;
      (pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section&#xD;
      (CS), and large-for-gestational-age babies (LGA)). These complications occur in 26% of&#xD;
      pregnancies with normal start BMI and adequate weight gain, in 34% in normal start BMI but&#xD;
      excessive gestational weight gain and in up to 66% in obese class III (BMI≥40kg/m²) combined&#xD;
      with excessive gestational weight gain. Moreover, as the prevalence of maternal obesity&#xD;
      continues to rise, increasing numbers of children are exposed to an 'obesogenic intrauterine&#xD;
      environment'. Obesity in pregnancy has therefore the potential to result in an&#xD;
      'intergenerational cycle' of obesity through in utero programming.&#xD;
&#xD;
      The investigators focus on women with excessive weight gain during their 1st pregnancy as&#xD;
      currently, half of them do not return to their pre-pregnancy weight before the next&#xD;
      pregnancy. This results in a complication rate as high as 42% (PIH, GDM, CS, LGA). The&#xD;
      investigators target a healthy BMI at start of pregnancy by intervening during the&#xD;
      pre-conception period- and an adequate weight gain during pregnancy by intervening during&#xD;
      pregnancy in these women. The intervention will be evaluated in a randomized controlled trial&#xD;
      including 1,100 women.&#xD;
&#xD;
      The proposed intervention combines face-to-face coaching with the use of a mobile App&#xD;
      (so-called 'inter-act' app) connected to medical devices (scale and pedometer). The app&#xD;
      monitors women's weight, eating behaviour, physical activity, mental wellbeing, and provides&#xD;
      continuously coaching through positive behavioral change techniques. The 'inter-act' App&#xD;
      covers after the 1st delivery breast-feeding support, while during pregnancy, the gestational&#xD;
      weight gain guidelines of the Institute of Medicine (IOM) are included.&#xD;
&#xD;
      Drop out of less motivated women is avoided as the time points of the four pre-conception&#xD;
      coaching sessions coincide with the existing postnatal follow-up visits for neonates&#xD;
      (Governmental vaccination scheme through the organisation &quot; Kind &amp; Gezin&quot;), and the three&#xD;
      pregnancy coaching sessions coincide with the three routine ultrasound scans during normal&#xD;
      pregnancy (KCE Guidelines).&#xD;
&#xD;
      Each year, there are 8,900 singleton pregnancies in Flanders in whom the mother had excessive&#xD;
      gestational weight gain in the prior pregnancy. The current rate of at least one of the four&#xD;
      major pregnancy and birth-related complications (PIH, GDM, CS, LGA) in the 8,900 pregnancies&#xD;
      is 42%. If the complications rate reduces with 1/4, this involves more than 900 pregnancies,&#xD;
      and reduces costs related to caesarean sections, gestational diabetes, obesity in mother &amp;&#xD;
      child.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of participants with at least one of the following four complications: pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, large-for-gestational age baby</measure>
    <time_frame>at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)</time_frame>
    <description>The existence of pregnancy-induced hypertension and gestational diabetes mellitus are assessed during pregnancy. Whether the 2nd pregnancy results in a caesarean section and large-for-gestational-age baby will be known at the time of delivery 2nd pregnancy. Therefore, the primary outcome of prevalence of participants with pregnancy and birth-related complications is assessed at the time of delivery 2nd pregnancy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drop out</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Drop-out rate and reason for drop-out</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of women who returned to their pre-pregnancy weight</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution underweight, normal weight, overweight, obese BMI</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Body composition measured by bio-electrical impedance analysis to estimate fat mass, fat free mass and muscle mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin fold measurements</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Skin fold measurements or determining body fat composition by use of a skinfold calliper.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast feeding behaviour</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Breast feeding (BF) habits are assessed by a structured questionnaire on breastfeeding practice. The questionnaire consists of eleven questions in Dutch, which investigates intention to BF, initiation to BF, exclusive BF, combination of bottle-feeding and BF and motives to cease BF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food intake</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>food intake is measured by a Food Frequency Questionnaire: frequency of food intake (per day, per week or per month) and portion size (in gram or millilitre).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Physical activity is measured using International Physical Activity Questionnaire (IPAQ), long version.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life style behaviour</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Life style behaviour: whether the mother is following a diet, smoking, sleep duration and quality of sleep, alcohol use (questionnaire).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Anxiety symptoms are measured with the Trait Anxiety Inventory (TAI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy</time_frame>
    <description>Levels of depression are measured with the reliable and valid 10-item Edinburgh Postnatal Depression Scale (PDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of patients with excessive gestational weight gain during their 2nd pregnancy.</measure>
    <time_frame>at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of preterm/term pregnancies</measure>
    <time_frame>at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of the intervention</measure>
    <time_frame>at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)</time_frame>
    <description>Costs related to these complications:&#xD;
caesarean section costs 4,013€ compared to 2,909€ for a vaginal delivery, resulting in a 4,013-2,909= 1,104€ additional cost per caesarean section (Onafhankelijke Ziekenfondsen, 2012).&#xD;
Gestational diabetes has an additional cost 820 € (Danyliv et al., IADPSG 2014, Gestational Diabetes and health care cost).&#xD;
There is also the impact of gestational diabetes on the baby. Intrauterine exposure through gestational diabetes predisposes the off-spring to diabetes: yearly cost for diabetes around 5,800€ (American Diabetes Association).&#xD;
Obesity: yearly additional direct medical cost for obesity approximately 3000 € per person due to increased contacts with health care providers and hospitalisation costs (De Jonghe E and Annemans L, 2009).&#xD;
The costs of the coaching sessions are based on the official nomenclature of midwives (RIZIV - Rijksinstituut voor ziekte- en invaliditeitsverzekering, Belgian institute)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of women who gave at least 6 months breast feeding</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1100</enrollment>
  <condition>Obesity</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INTER-ACT arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four pre-conception coaching sessions : postpartum week 6, week 8, week 12, 6 months.&#xD;
Three pregnancy coaching sessions: at the time of the planned ultrasound scans.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>INTER-ACT</intervention_name>
    <description>Pre-conception coaching sessions: We encourage less motivated women to participate to the trial by collaborating with Kind &amp; Gezin from the very beginning, as most timepoints of the counselling sessions coincide with the time points of the Kind&amp;Gezin vaccine scheme (postpartum week 6, week 8, week 12, 6 months). We will organize the coaching in a &quot;mother and baby friendly&quot; community-based setting or in the hospitals, as preferred by the mothers.&#xD;
Pregnancy coaching sessions: take place in hospital, at the time of the three planned ultrasound scans.&#xD;
By consequence, the applied methodology can be applied as such at the moment of global utilisation in Flanders.</description>
    <arm_group_label>INTER-ACT arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Excessive weight gain during their previous pregnancy (above the IOM recommendations)&#xD;
&#xD;
          -  Child wish for having a next pregnancy&#xD;
&#xD;
          -  Women aged 18 years or more&#xD;
&#xD;
          -  Sufficient fluent in Dutch language&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
          -  Able to use a smartphone. If the women do not have a smartphone because of&#xD;
             socio-economic reasons, a smartphone is at her disposal for the whole duration of the&#xD;
             intervention, in order to be able to use Apps connected with a Bluetooth pedometer and&#xD;
             balance scale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement for (complex) diets&#xD;
&#xD;
          -  History of or a plan for bariatric surgery&#xD;
&#xD;
          -  Underlying or chronic disorders (e.g. diabetes, thyroid disease, renal diseases)&#xD;
&#xD;
          -  Significant psychiatric disorder&#xD;
&#xD;
          -  Previous still birth&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roland Devlieger, PhD, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Katholieke Universiteit Leuven, Department of Development and Regeneration</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annick Bogaerts, PhD</last_name>
    <phone>++3216342810</phone>
    <email>annick.bogaerts@ucll.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Roland Devlieger, Phd, MD</last_name>
    <email>Roland.Devlieger@med.kuleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZA</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuizen GasthuisZusters Antwerpen (GZA)</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg (ZOL)</name>
      <address>
        <city>Genk</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jessa ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sint-Franciskusziekenhuis</name>
      <address>
        <city>Heusden</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>June 9, 2017</last_update_submitted>
  <last_update_submitted_qc>June 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>dr. Annick Bogaerts</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>interpregnancy</keyword>
  <keyword>pregnancy-induced hypertension</keyword>
  <keyword>gestational diabetes mellitus</keyword>
  <keyword>caesarean section</keyword>
  <keyword>large-for-gestational-age</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989142
org study id: T005116N
nct id: NCT02989142
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The project focuses on prevention of major pregnancy and birth related complications :
      pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section
      (CS), and large-for-gestational-age (LGA), i.e. the birth weight of the baby exceeds the 90%
      percentile of birth weights for the specific pregnancy duration.

      The investigators focus on the pre-conception period, i.e. the pre-conception period of the
      2nd pregnancy in women with an excessive weight gain during their 1st pregnancy, aiming to
      decrease the complications rate in their 2nd pregnancy.

      Women with an excessive gestational weight gain have obtained the extra weight during a
      rather short period of time, e.g. 20 kilos in the last 4 or 5 months of their pregnancy. This
      characteristic distinguishes the target group from the general population with
      overweight/obesity, in whom the extra weight was acquired during many years and independent
      from a pregnancy, making a behaviour change more complex.

      The coaching intervention combines face-to-face counselling with the use of a mobile App
      connected to medical devices (scale and pedometer). The app monitors important indicators
      (weight, eating behaviour, physical activity, mental wellbeing), provides coaching through
      established behavioral change techniques, and is specifically tailored for women with
      excessive weight gain during the previous pregnancy.

      The goal is to decrease the rate of pregnancy and birth-related adverse outcomes in the next
      pregnancy by a healthy life style, starting shortly after their 1st delivery and sustained
      during the next pregnancy.
The aim is to decrease the prevalence of pregnancy and birth-related complications
      (pregnancy-induced hypertension (PIH), gestational diabetes mellitus (GDM), caesarean section
      (CS), and large-for-gestational-age babies (LGA)). These complications occur in 26% of
      pregnancies with normal start BMI and adequate weight gain, in 34% in normal start BMI but
      excessive gestational weight gain and in up to 66% in obese class III (BMI≥40kg/m²) combined
      with excessive gestational weight gain. Moreover, as the prevalence of maternal obesity
      continues to rise, increasing numbers of children are exposed to an 'obesogenic intrauterine
      environment'. Obesity in pregnancy has therefore the potential to result in an
      'intergenerational cycle' of obesity through in utero programming.

      The investigators focus on women with excessive weight gain during their 1st pregnancy as
      currently, half of them do not return to their pre-pregnancy weight before the next
      pregnancy. This results in a complication rate as high as 42% (PIH, GDM, CS, LGA). The
      investigators target a healthy BMI at start of pregnancy by intervening during the
      pre-conception period- and an adequate weight gain during pregnancy by intervening during
      pregnancy in these women. The intervention will be evaluated in a randomized controlled trial
      including 1,100 women.

      The proposed intervention combines face-to-face coaching with the use of a mobile App
      (so-called 'inter-act' app) connected to medical devices (scale and pedometer). The app
      monitors women's weight, eating behaviour, physical activity, mental wellbeing, and provides
      continuously coaching through positive behavioral change techniques. The 'inter-act' App
      covers after the 1st delivery breast-feeding support, while during pregnancy, the gestational
      weight gain guidelines of the Institute of Medicine (IOM) are included.

      Drop out of less motivated women is avoided as the time points of the four pre-conception
      coaching sessions coincide with the existing postnatal follow-up visits for neonates
      (Governmental vaccination scheme through the organisation " Kind & Gezin"), and the three
      pregnancy coaching sessions coincide with the three routine ultrasound scans during normal
      pregnancy (KCE Guidelines).

      Each year, there are 8,900 singleton pregnancies in Flanders in whom the mother had excessive
      gestational weight gain in the prior pregnancy. The current rate of at least one of the four
      major pregnancy and birth-related complications (PIH, GDM, CS, LGA) in the 8,900 pregnancies
      is 42%. If the complications rate reduces with 1/4, this involves more than 900 pregnancies,
      and reduces costs related to caesarean sections, gestational diabetes, obesity in mother &
      child.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: prevalence of participants with at least one of the following four complications: pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, large-for-gestational age baby
time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
description: The existence of pregnancy-induced hypertension and gestational diabetes mellitus are assessed during pregnancy. Whether the 2nd pregnancy results in a caesarean section and large-for-gestational-age baby will be known at the time of delivery 2nd pregnancy. Therefore, the primary outcome of prevalence of participants with pregnancy and birth-related complications is assessed at the time of delivery 2nd pregnancy.
measure: Drop out
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Drop-out rate and reason for drop-out
measure: Rate of women who returned to their pre-pregnancy weight
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Distribution underweight, normal weight, overweight, obese BMI
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
measure: Body composition
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Body composition measured by bio-electrical impedance analysis to estimate fat mass, fat free mass and muscle mass.
measure: Skin fold measurements
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Skin fold measurements or determining body fat composition by use of a skinfold calliper.
measure: Breast feeding behaviour
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Breast feeding (BF) habits are assessed by a structured questionnaire on breastfeeding practice. The questionnaire consists of eleven questions in Dutch, which investigates intention to BF, initiation to BF, exclusive BF, combination of bottle-feeding and BF and motives to cease BF.
measure: Food intake
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: food intake is measured by a Food Frequency Questionnaire: frequency of food intake (per day, per week or per month) and portion size (in gram or millilitre).
measure: Physical activity
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Physical activity is measured using International Physical Activity Questionnaire (IPAQ), long version.
measure: Life style behaviour
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Life style behaviour: whether the mother is following a diet, smoking, sleep duration and quality of sleep, alcohol use (questionnaire).
measure: Anxiety
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Anxiety symptoms are measured with the Trait Anxiety Inventory (TAI).
measure: Depression
time frame: at 6 months, at 12 months, at 18 months .... till delivery 2nd pregnancy
description: Levels of depression are measured with the reliable and valid 10-item Edinburgh Postnatal Depression Scale (PDS).
measure: rate of patients with excessive gestational weight gain during their 2nd pregnancy.
time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
measure: Rate of preterm/term pregnancies
time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
measure: Cost-effectiveness of the intervention
time frame: at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks)
description: Costs related to these complications:
caesarean section costs 4,013€ compared to 2,909€ for a vaginal delivery, resulting in a 4,013-2,909= 1,104€ additional cost per caesarean section (Onafhankelijke Ziekenfondsen, 2012).
Gestational diabetes has an additional cost 820 € (Danyliv et al., IADPSG 2014, Gestational Diabetes and health care cost).
There is also the impact of gestational diabetes on the baby. Intrauterine exposure through gestational diabetes predisposes the off-spring to diabetes: yearly cost for diabetes around 5,800€ (American Diabetes Association).
Obesity: yearly additional direct medical cost for obesity approximately 3000 € per person due to increased contacts with health care providers and hospitalisation costs (De Jonghe E and Annemans L, 2009).
The costs of the coaching sessions are based on the official nomenclature of midwives (RIZIV - Rijksinstituut voor ziekte- en invaliditeitsverzekering, Belgian institute)
measure: Number of women who gave at least 6 months breast feeding
time frame: at 6 months
arm group label: Control arm
arm group type: No Intervention
description: No intervention
arm group label: INTER-ACT arm
arm group type: Experimental
description: Four pre-conception coaching sessions : postpartum week 6, week 8, week 12, 6 months.
Three pregnancy coaching sessions: at the time of the planned ultrasound scans.
intervention type: Behavioral
intervention name: INTER-ACT
description: Pre-conception coaching sessions: We encourage less motivated women to participate to the trial by collaborating with Kind & Gezin from the very beginning, as most timepoints of the counselling sessions coincide with the time points of the Kind&Gezin vaccine scheme (postpartum week 6, week 8, week 12, 6 months). We will organize the coaching in a "mother and baby friendly" community-based setting or in the hospitals, as preferred by the mothers.
Pregnancy coaching sessions: take place in hospital, at the time of the three planned ultrasound scans.
By consequence, the applied methodology can be applied as such at the moment of global utilisation in Flanders.
arm group label: INTER-ACT arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Roland Devlieger, PhD, MD
role: Study Chair
affiliation: Katholieke Universiteit Leuven, Department of Development and Regeneration
last name: Annick Bogaerts, PhD
phone: ++3216342810
email: annick.bogaerts@ucll.be
last name: Roland Devlieger, Phd, MD
email: Roland.Devlieger@med.kuleuven.be
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: dr. Annick Bogaerts
investigator title: Prof. dr.
sharing ipd: No