<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/NCT01689961</url>
  </required_header>
  <id_info>
    <org_study_id>12-469</org_study_id>
    <nct_id>NCT01689961</nct_id>
  </id_info>
  <brief_title>Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise</brief_title>
  <acronym>BHIP</acronym>
  <official_title>Be Healthy in Pregnancy (BHIP) With Nutrition and Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agriculture and Agri-Food Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dairy Farmers of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who&#xD;
      enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess&#xD;
      weight gain puts mothers at risk for health problems such as diabetes and developing or&#xD;
      sustaining obesity after pregnancy, and puts their babies at risk of being born too large or&#xD;
      developing related health problems. Mothers will be randomized to a structured high dairy&#xD;
      protein diet and walking program or the usual care by their care provider. The investigators&#xD;
      research questions are: Will a structured nutrition and exercise program in pregnancy&#xD;
      compared to usual prenatal care increase the chance that mothers will achieve pregnancy&#xD;
      weight gain within the current recommendations; improve health measures, in mother and infant&#xD;
      at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on&#xD;
      maintenance of bone status in the mother and bone health outcomes in the child in early life&#xD;
      (6 months); and to investigate the interactions between genes associated with bone health and&#xD;
      high dairy diet supplementation on bone status in mothers during pregnancy, and bone health&#xD;
      in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity&#xD;
      and adherence to the nutrition plan will be assessed until birth and at follow-up with their&#xD;
      infants at 6 months after birth. The research team will ensure new information is quickly&#xD;
      transferred to programs to assist women to have healthier pregnancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a 2-arm randomized 3-site trial. Recruitment will be within the community care&#xD;
      clinics by poster and flyer advertisements. Pregnant women will be stratified by BMI&#xD;
      categories and study site and randomized within strata to Group A (Nutrition+Exercise&#xD;
      intervention program) or Group B (Usual Prenatal Care + Health Canada materials about healthy&#xD;
      pregnancy + two focus group sessions exploring women's experiences with exercise, nutrition&#xD;
      and weight gain in pregnancy).&#xD;
&#xD;
      Primary research question: Among pregnant women, does introducing a structured and monitored&#xD;
      nutrition and exercise program (treatment) in early pregnancy compared with Usual Prenatal&#xD;
      Care (control) increase the likelihood of attaining gestational weight gain within the&#xD;
      Institute of Medicine (IOM) guidelines over the pregnancy period? Secondary research&#xD;
      questions: Among pregnant women (population), does introducing a structured and monitored&#xD;
      nutrition and exercise program in early pregnancy (intervention) compared with Standard&#xD;
      Prenatal Care (control) lead to 1) better maternal outcomes (outcome) at 6 months post-&#xD;
      partum; and ii) better infant outcomes (outcome) at 6 months post partum?; and 2) i) to&#xD;
      evaluate the benefits of a high dairy intake in pregnancy on maintenance of bone status in&#xD;
      the mother and bone health outcomes in the child in early life (6 months); and ii) to&#xD;
      investigate the interactions between genes associated with bone health and high dairy diet&#xD;
      supplementation on bone status in mothers during pregnancy, and bone health in mothers&#xD;
      post-delivery and children to 6 months of age.&#xD;
&#xD;
      Experimental and Control groups: Both groups of mothers and their health care providers will&#xD;
      be given the Health Canada materials on &quot;Healthy Weight Gain during Pregnancy&quot;, &quot;Eating Well&#xD;
      with Canada's Food Guide&quot; and the &quot;Pregnancy Weight Gain Calculator&quot;. Baseline information&#xD;
      will be recorded for eligible and consenting women after which they will be randomized to&#xD;
      Experimental or Control group. Nutrition intake, physical measures and physical activity will&#xD;
      be recorded at baseline, 26-28 weeks, 36-38 weeks of gestation, and 6 months postpartum in&#xD;
      the same manner for both groups. All mothers will receive the study promotional materials and&#xD;
      small incentives. Also, all mothers will be followed by their primary care provider and have&#xD;
      usual access to public health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational weight gain within IOM guidelines</measure>
    <time_frame>Change from baseline at 38 weeks gestation</time_frame>
    <description>Among pregnant women (population), does introducing a structured and monitored nutrition and exercise program (treatment) in early pregnancy compared with Usual Prenatal Care (control) increase the likelihood of attaining gestational weight gain within the IOM guidelines (outcome) over the pregnancy period?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal and infant outcomes</measure>
    <time_frame>6 months postpartum</time_frame>
    <description>The secondary research question is whether the proposed intervention will result in i) better maternal outcomes (outcome) at 6 months post- partum; and ii) better infant outcomes (outcome) at 6 months post partum?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone health of mother and baby</measure>
    <time_frame>6 months post-partum</time_frame>
    <description>In mother: plasma/serum measures of bone mineralization and bone resorption and vitamin D status; bone mineral density as measured by dual energy x-ray absorptiometry scan.&#xD;
In infant: bone mineral content as measured by dual energy x-ray absorptiometry scan.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">242</enrollment>
  <condition>Pregnancy Complications</condition>
  <condition>Weight Gain</condition>
  <arm_group>
    <arm_group_label>Nutrition+Exercise Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured + monitored nutrition and exercise intervention:&#xD;
The exercise intervention includes a custom-designed pregnancy-specific group walking class of 30-60 min. 1x/week and a prescribed at-home walking program for 10,000 steps/day. The nutrition intervention is a high protein (25% energy) low-fat dairy food plan designed to meet energy needs and with individualized counselling. The intervention will include 2 x/month weight monitoring and records of nutrition and activity to ensure adherence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Prenatal Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Mothers in the Control Group will be followed by their primary care provider and have usual access to public health services. In addition, they will be asked to attend 2 focus group sessions exploring women's experiences with exercise, nutrition, and weight gain in pregnancy. Women will receive information about healthy pregnancy from Health Canada.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured + monitored nutrition and exercise intervention</intervention_name>
    <description>The exercise intervention includes a custom-designed pregnancy-specific group walking class of 30-60 min. 1x/week and a prescribed at-home walking program for 10,000 steps/day. The nutrition intervention is a high protein (25% energy) low-fat dairy food plan designed to meet energy needs and with individualized counselling. The intervention will include 2 x/month weight monitoring and records of nutrition and activity to ensure adherence.</description>
    <arm_group_label>Nutrition+Exercise Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy pregnant females &gt; 18 years of age with singleton pregnancies (either&#xD;
             nulliparous or multiparous);&#xD;
&#xD;
          -  less than 17 weeks gestation;&#xD;
&#xD;
          -  a pre pregnancy BMI &lt; 40 kg/m2 (owing to the fact that severe obesity with BMI&gt; 40 may&#xD;
             have limitations with respect to physical activity);&#xD;
&#xD;
          -  plans to deliver at a Hamilton or London regional hospital or by home birth and&#xD;
             willing to attend research visits at the community site where they were recruited;&#xD;
&#xD;
          -  able to tolerate dairy foods;&#xD;
&#xD;
          -  approval of primary care provider;&#xD;
&#xD;
          -  able to provide signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to understand some English;&#xD;
&#xD;
          -  type 1 or type 2 diabetes;&#xD;
&#xD;
          -  known contraindications to exercise as recommended by the Canadian clinical practice&#xD;
             guidelines for pregnancy;&#xD;
&#xD;
          -  severe gastrointestinal diseases or conditions;&#xD;
&#xD;
          -  any significant heart, kidney, liver or pancreatic diseases;&#xD;
&#xD;
          -  pre-existing diabetes;&#xD;
&#xD;
          -  currently smoking;&#xD;
&#xD;
          -  a depression score 12 or above on the validated Edinburgh depression questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephanie A Atkinson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Burlington Midwives Clinic</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster Family Health Team</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Midwives Clinics</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Exercise and Pregnancy Laboratory</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Gestational weight gain</keyword>
  <keyword>Pregnancy outcomes</keyword>
  <keyword>Birth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
  </condition_browse>
  <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/NCT01689961
org study id: 12-469
nct id: NCT01689961
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Excess weight gain in pregnancy is a major problem affecting 55-75% of Canadian women who
      enter pregnancy overweight or obese and about 40% of women who are normal weight. Excess
      weight gain puts mothers at risk for health problems such as diabetes and developing or
      sustaining obesity after pregnancy, and puts their babies at risk of being born too large or
      developing related health problems. Mothers will be randomized to a structured high dairy
      protein diet and walking program or the usual care by their care provider. The investigators
      research questions are: Will a structured nutrition and exercise program in pregnancy
      compared to usual prenatal care increase the chance that mothers will achieve pregnancy
      weight gain within the current recommendations; improve health measures, in mother and infant
      at six months post-partum; to evaluate the benefits of a high dairy intake in pregnancy on
      maintenance of bone status in the mother and bone health outcomes in the child in early life
      (6 months); and to investigate the interactions between genes associated with bone health and
      high dairy diet supplementation on bone status in mothers during pregnancy, and bone health
      in mothers post-delivery and children to 6 months of age. Mothers' weight, physical activity
      and adherence to the nutrition plan will be assessed until birth and at follow-up with their
      infants at 6 months after birth. The research team will ensure new information is quickly
      transferred to programs to assist women to have healthier pregnancies.
This will be a 2-arm randomized 3-site trial. Recruitment will be within the community care
      clinics by poster and flyer advertisements. Pregnant women will be stratified by BMI
      categories and study site and randomized within strata to Group A (Nutrition+Exercise
      intervention program) or Group B (Usual Prenatal Care + Health Canada materials about healthy
      pregnancy + two focus group sessions exploring women's experiences with exercise, nutrition
      and weight gain in pregnancy).

      Primary research question: Among pregnant women, does introducing a structured and monitored
      nutrition and exercise program (treatment) in early pregnancy compared with Usual Prenatal
      Care (control) increase the likelihood of attaining gestational weight gain within the
      Institute of Medicine (IOM) guidelines over the pregnancy period? Secondary research
      questions: Among pregnant women (population), does introducing a structured and monitored
      nutrition and exercise program in early pregnancy (intervention) compared with Standard
      Prenatal Care (control) lead to 1) better maternal outcomes (outcome) at 6 months post-
      partum; and ii) better infant outcomes (outcome) at 6 months post partum?; and 2) i) to
      evaluate the benefits of a high dairy intake in pregnancy on maintenance of bone status in
      the mother and bone health outcomes in the child in early life (6 months); and ii) to
      investigate the interactions between genes associated with bone health and high dairy diet
      supplementation on bone status in mothers during pregnancy, and bone health in mothers
      post-delivery and children to 6 months of age.

      Experimental and Control groups: Both groups of mothers and their health care providers will
      be given the Health Canada materials on "Healthy Weight Gain during Pregnancy", "Eating Well
      with Canada's Food Guide" and the "Pregnancy Weight Gain Calculator". Baseline information
      will be recorded for eligible and consenting women after which they will be randomized to
      Experimental or Control group. Nutrition intake, physical measures and physical activity will
      be recorded at baseline, 26-28 weeks, 36-38 weeks of gestation, and 6 months postpartum in
      the same manner for both groups. All mothers will receive the study promotional materials and
      small incentives. Also, all mothers will be followed by their primary care provider and have
      usual access to public health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Gestational weight gain within IOM guidelines
time frame: Change from baseline at 38 weeks gestation
description: Among pregnant women (population), does introducing a structured and monitored nutrition and exercise program (treatment) in early pregnancy compared with Usual Prenatal Care (control) increase the likelihood of attaining gestational weight gain within the IOM guidelines (outcome) over the pregnancy period?
measure: Maternal and infant outcomes
time frame: 6 months postpartum
description: The secondary research question is whether the proposed intervention will result in i) better maternal outcomes (outcome) at 6 months post- partum; and ii) better infant outcomes (outcome) at 6 months post partum?
measure: Bone health of mother and baby
time frame: 6 months post-partum
description: In mother: plasma/serum measures of bone mineralization and bone resorption and vitamin D status; bone mineral density as measured by dual energy x-ray absorptiometry scan.
In infant: bone mineral content as measured by dual energy x-ray absorptiometry scan.
arm group label: Nutrition+Exercise Intervention
arm group type: Experimental
description: Structured + monitored nutrition and exercise intervention:
The exercise intervention includes a custom-designed pregnancy-specific group walking class of 30-60 min. 1x/week and a prescribed at-home walking program for 10,000 steps/day. The nutrition intervention is a high protein (25% energy) low-fat dairy food plan designed to meet energy needs and with individualized counselling. The intervention will include 2 x/month weight monitoring and records of nutrition and activity to ensure adherence
arm group label: Usual Prenatal Care
arm group type: No Intervention
description: Mothers in the Control Group will be followed by their primary care provider and have usual access to public health services. In addition, they will be asked to attend 2 focus group sessions exploring women's experiences with exercise, nutrition, and weight gain in pregnancy. Women will receive information about healthy pregnancy from Health Canada.
intervention type: Behavioral
intervention name: Structured + monitored nutrition and exercise intervention
description: The exercise intervention includes a custom-designed pregnancy-specific group walking class of 30-60 min. 1x/week and a prescribed at-home walking program for 10,000 steps/day. The nutrition intervention is a high protein (25% energy) low-fat dairy food plan designed to meet energy needs and with individualized counselling. The intervention will include 2 x/month weight monitoring and records of nutrition and activity to ensure adherence.
arm group label: Nutrition+Exercise Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Stephanie A Atkinson, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Pregnancy Complications
mesh term: Weight Gain
sharing ipd: No