<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/NCT01693510</url>
  </required_header>
  <id_info>
    <org_study_id>BHIP-DFC</org_study_id>
    <nct_id>NCT01693510</nct_id>
  </id_info>
  <brief_title>Be Healthy in Pregnancy (B-HIP): A Trial to Study Nutrition and Exercise Approaches for Healthy Pregnancy</brief_title>
  <acronym>BHIP</acronym>
  <official_title>Be Healthy in Pregnancy (B-HIP): A Randomized Clinical Trial (RCT) to Study Nutrition and Exercise Approaches for Healthy Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <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>
      Weight gained during pregnancy is referred to as gestational weight gain (GWG). Excess GWG is&#xD;
      a widespread problem that occurs in 55-75% of Canadian women who enter pregnancy overweight&#xD;
      or obese (a group that represents over 50 % of all pregnant women) and about 40% women of&#xD;
      normal weight. Excess GWG is associated with complications of pregnancy, such as post-partum&#xD;
      weight retention, type 2 diabetes, elevated fats in the blood, and high blood pressure and&#xD;
      may also lead to problems with the health of the newborn child. Our research aims to find&#xD;
      ways to control GWG by developing new and practical approaches to diet and exercise targeted&#xD;
      to overweight pregnant women that hold promise of improving their health both during&#xD;
      pregnancy and thereafter. The experimental intervention is a diet of higher protein provided&#xD;
      by dairy foods combined with an exercise program modified to the abilities of overweight&#xD;
      pregnant women; and the control is the usual advice given by their primary care providers,&#xD;
      information on healthy pregnancy from Health Canada, and a focus group session exploring&#xD;
      women's experiences with exercise, nutrition, and gestational weight gain. The results of&#xD;
      this study will allow us to design future large clinical studies in all pregnant women to&#xD;
      help control the weight gain in all pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a 2-arm randomized 1-site trial. Recruitment will be within the community care&#xD;
      clinics by poster and flyer advertisements.&#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?&#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 and 36-38 weeks of gestation and 6 months post partum 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 12, 2012</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</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 GWG within the IOM guidelines (outcome) over the pregnancy period?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone outcomes</measure>
    <time_frame>6 months post-partum</time_frame>
    <description>Bone status in mothers and infants at 6 months after delivery will be assessed against reference data for bone mineral content (infants) or bone mineral density (mothers) and anthropomorphic outcomes in babies (weight and height).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Excessive Weight Gain in Pregnancy as Antepartum Condition</condition>
  <condition>Obesity</condition>
  <condition>Weight Gain</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Exercise and Nutrition Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutrition intervention: The proposed nutrition plan is a high protein (25% energy) diet providing low fat dairy foods and individualized to energy needs. Dairy foods are accepted by women during pregnancy as a healthy choice (from pilot study) and in our recent birth cohort study, women consumed an average of 3 or more servings of dairy per day. Exercise intervention: Most previous studies and published guidance focus on aerobic exercise such as walking as it is the easiest physical activity to implement in pregnancy in terms of setting goals of steps and monitoring of adherence using accelerometer-type devices. Walking is also the most practical since women reduced moderate and vigorous physical activity during pregnancy but levels of walking were maintained.</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. In addition, women will have the opportunity to attend one focus group session exploring women's experiences with nutrition, exercise, and weight gain in pregnancy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise and Nutrition Intervention</intervention_name>
    <description>Both Intervention and Control participants and their care providers receive the new Health Canada guide on Healthy Weight Gain During Pregnancy. For the Experimental Group, 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 to reach 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.</description>
    <arm_group_label>Exercise and Nutrition 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); less than 20 weeks gestation; pre-pregnancy BMI of &gt;25&#xD;
             and &lt; 40 kg/m2 (owing to the fact that severe obesity with BMI&gt; 40 may have&#xD;
             limitations with respect to physical activity); plans to deliver at a Hamilton Health&#xD;
             Sciences, St. Joseph's Healthcare Hamilton, Joseph Brant Hospital or by home birth but&#xD;
             willing to attend research visits at the McMaster University Medical Centre site;&#xD;
             approval of primary care provider; and able to provide signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand some English; currently breastfeeding previous child; pregnancy&#xD;
             resulting from in vitro fertilization; known contraindications to exercise as&#xD;
             recommended by the Canadian clinical practice guidelines for pregnancy; severe chronic&#xD;
             gastrointestinal diseases or conditions; refusal to consume dairy foods due to&#xD;
             intolerance or dislike; any significant heart, kidney, liver or pancreatic diseases;&#xD;
             pre-existing diabetes; or a depression score above 13 on the validated Edinburgh&#xD;
             Depression scale as that is indicative of severe depression and should be referred for&#xD;
             treatment; currently smoking.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>McMaster University Medical Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 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>Excess gestational weight gain (GWG)</keyword>
  <keyword>Obesity</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>Elevated fats in the blood</keyword>
  <keyword>High blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Body Weight</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/NCT01693510
org study id: BHIP-DFC
nct id: NCT01693510
lead sponsor: 
collaborator: 
has dmc: Yes
Weight gained during pregnancy is referred to as gestational weight gain (GWG). Excess GWG is
      a widespread problem that occurs in 55-75% of Canadian women who enter pregnancy overweight
      or obese (a group that represents over 50 % of all pregnant women) and about 40% women of
      normal weight. Excess GWG is associated with complications of pregnancy, such as post-partum
      weight retention, type 2 diabetes, elevated fats in the blood, and high blood pressure and
      may also lead to problems with the health of the newborn child. Our research aims to find
      ways to control GWG by developing new and practical approaches to diet and exercise targeted
      to overweight pregnant women that hold promise of improving their health both during
      pregnancy and thereafter. The experimental intervention is a diet of higher protein provided
      by dairy foods combined with an exercise program modified to the abilities of overweight
      pregnant women; and the control is the usual advice given by their primary care providers,
      information on healthy pregnancy from Health Canada, and a focus group session exploring
      women's experiences with exercise, nutrition, and gestational weight gain. The results of
      this study will allow us to design future large clinical studies in all pregnant women to
      help control the weight gain in all pregnant women.
This will be a 2-arm randomized 1-site trial. Recruitment will be within the community care
      clinics by poster and flyer advertisements.

      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?

      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 and 36-38 weeks of gestation and 6 months post partum 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: Treatment
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 GWG within the IOM guidelines (outcome) over the pregnancy period?
measure: Bone outcomes
time frame: 6 months post-partum
description: Bone status in mothers and infants at 6 months after delivery will be assessed against reference data for bone mineral content (infants) or bone mineral density (mothers) and anthropomorphic outcomes in babies (weight and height).
arm group label: Exercise and Nutrition Intervention
arm group type: Experimental
description: Nutrition intervention: The proposed nutrition plan is a high protein (25% energy) diet providing low fat dairy foods and individualized to energy needs. Dairy foods are accepted by women during pregnancy as a healthy choice (from pilot study) and in our recent birth cohort study, women consumed an average of 3 or more servings of dairy per day. Exercise intervention: Most previous studies and published guidance focus on aerobic exercise such as walking as it is the easiest physical activity to implement in pregnancy in terms of setting goals of steps and monitoring of adherence using accelerometer-type devices. Walking is also the most practical since women reduced moderate and vigorous physical activity during pregnancy but levels of walking were maintained.
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. In addition, women will have the opportunity to attend one focus group session exploring women's experiences with nutrition, exercise, and weight gain in pregnancy.
intervention type: Behavioral
intervention name: Exercise and Nutrition Intervention
description: Both Intervention and Control participants and their care providers receive the new Health Canada guide on Healthy Weight Gain During Pregnancy. For the Experimental Group, 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 to reach 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.
arm group label: Exercise and Nutrition Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephanie A. Atkinson, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
mesh term: Body Weight
mesh term: Weight Gain
sharing ipd: No