<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/NCT03298555</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01147</org_study_id>
    <nct_id>NCT03298555</nct_id>
  </id_info>
  <brief_title>The HealthyMoms Trial to Promote Healthy Gestational Weight Gain</brief_title>
  <official_title>A Smartphone Application (HealthyMoms) to Promote Healthy Weight Gain, Diet and Physical Activity During Pregnancy: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</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>
      Excessive gestational weight gain is a major public health problem. Traditional face-to-face&#xD;
      intervention programs has been shown to be succesful in order to promote healthier weight&#xD;
      gains, however, they are time-consuming and expensive. The objectives of this study are to&#xD;
      assess whether a 6-month smartphone application can promote healthy gestational weight gain,&#xD;
      dietary habits and physical activity in pregnant women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Excessive gestational weight gain (GWG) increases risks for pregnancy complications,&#xD;
      postpartum weight retention and offspring obesity. Traditional intervention programs are time&#xD;
      and cost intensive. Mobile technology (mHealth) has been successful for weight loss and&#xD;
      behavior changes; however, their use in pregnancy need to be further examined. This study&#xD;
      aims to evaluate the impact of a smartphone application (app) intervention on GWG, diet,&#xD;
      physical activity and glucose homeostasis.&#xD;
&#xD;
      HealthyMoms is a randomized controlled trial recruiting women at the first maternity clinic&#xD;
      visit (week 6-10) in the Linköping area, Sweden. Women will be randomized to the control or&#xD;
      intervention group (n=150 per group). All women will receive standard care. The intervention&#xD;
      group will also receive the HealthyMoms smartphone app promoting healthy eating, activity and&#xD;
      GWG during 6 months. Pregnancy outcomes are GWG (primary), food intake (web-based&#xD;
      questionnaire), fat mass (BodPod), glucose homeostasis, activity (accelerometer) in week 37.&#xD;
      Maternal and infant body fatness will be assessed one week post partum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">November 4, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational weight gain</measure>
    <time_frame>At the end of the intervention which is 23 weeks after baseline</time_frame>
    <description>Body weight in gestational week 37 minus body weight in gestational week 14</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body fatness using air-displacement plethysmography</measure>
    <time_frame>At the end of the intervention which is 23 weeks after baseline</time_frame>
    <description>Body fatness in gestational week 37 minus body fatness in gestational week 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity using accelerometry</measure>
    <time_frame>At the end of the intervention which is 23 weeks after baseline</time_frame>
    <description>Moderate-to-vigorous physical activity (MVPA) in gestational week 37 minus MVPA in gestational week 14. MVPA will be assessed using wrist-worn accelerometry (Actigraph wGT3x) during 7 days at both time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet quality using a web-based questionnaire</measure>
    <time_frame>At the end of the intervention which is 23 weeks after baseline</time_frame>
    <description>Diet quality in gestational week 37 minus diet quality in gestational week 14. Diet quality will be assessed using a web-based questionnaire (a combination of a food-frequency questionnaire and two 24 hour recalls)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemia</measure>
    <time_frame>At the end of the intervention which is 23 weeks after baseline</time_frame>
    <description>Plasma glucose levels in gestational week 37 minus plasma glucose levels in gestational week 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal body fatness post partum</measure>
    <time_frame>One week post partum</time_frame>
    <description>Maternal body fatness 1 week post partum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant body fatness</measure>
    <time_frame>One week of age</time_frame>
    <description>Infant body fatness at 1 week of age</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">305</enrollment>
  <condition>Gestational Mothers</condition>
  <condition>Weight Gain</condition>
  <arm_group>
    <arm_group_label>Mobile phone based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive the smartphone app HealthyMoms between gestational week 14 and 37. The app will contain information and support to achieve a healthy weight gain and lifestyle during pregnancy. This group will also receive standard care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will only receive standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile phone based intervention</intervention_name>
    <description>Participants in the intervention group will receive a 6-month mobile phone based program via a mobile phone application specifically designed for this study. The program will include information, advice and strategies to promote healthy gestational weight gain.</description>
    <arm_group_label>Mobile phone based intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a single pregnancy&#xD;
&#xD;
          -  aged 18 years or above&#xD;
&#xD;
          -  be able to speak and read Swedish sufficiently well.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous diagnosed eating disorder&#xD;
&#xD;
          -  pre-pregnancy diabetes or medical conditions or pharmacological treatments prior to&#xD;
             pregnancy that may affect body weight&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Löf, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Marie Löf, docent</investigator_full_name>
    <investigator_title>Senior researcher, associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03298555
org study id: 2016-01147
nct id: NCT03298555
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Excessive gestational weight gain is a major public health problem. Traditional face-to-face
      intervention programs has been shown to be succesful in order to promote healthier weight
      gains, however, they are time-consuming and expensive. The objectives of this study are to
      assess whether a 6-month smartphone application can promote healthy gestational weight gain,
      dietary habits and physical activity in pregnant women.
Excessive gestational weight gain (GWG) increases risks for pregnancy complications,
      postpartum weight retention and offspring obesity. Traditional intervention programs are time
      and cost intensive. Mobile technology (mHealth) has been successful for weight loss and
      behavior changes; however, their use in pregnancy need to be further examined. This study
      aims to evaluate the impact of a smartphone application (app) intervention on GWG, diet,
      physical activity and glucose homeostasis.

      HealthyMoms is a randomized controlled trial recruiting women at the first maternity clinic
      visit (week 6-10) in the Linköping area, Sweden. Women will be randomized to the control or
      intervention group (n=150 per group). All women will receive standard care. The intervention
      group will also receive the HealthyMoms smartphone app promoting healthy eating, activity and
      GWG during 6 months. Pregnancy outcomes are GWG (primary), food intake (web-based
      questionnaire), fat mass (BodPod), glucose homeostasis, activity (accelerometer) in week 37.
      Maternal and infant body fatness will be assessed one week post partum.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Care Provider, Investigator)
measure: Gestational weight gain
time frame: At the end of the intervention which is 23 weeks after baseline
description: Body weight in gestational week 37 minus body weight in gestational week 14
measure: Body fatness using air-displacement plethysmography
time frame: At the end of the intervention which is 23 weeks after baseline
description: Body fatness in gestational week 37 minus body fatness in gestational week 14
measure: Physical activity using accelerometry
time frame: At the end of the intervention which is 23 weeks after baseline
description: Moderate-to-vigorous physical activity (MVPA) in gestational week 37 minus MVPA in gestational week 14. MVPA will be assessed using wrist-worn accelerometry (Actigraph wGT3x) during 7 days at both time points.
measure: Diet quality using a web-based questionnaire
time frame: At the end of the intervention which is 23 weeks after baseline
description: Diet quality in gestational week 37 minus diet quality in gestational week 14. Diet quality will be assessed using a web-based questionnaire (a combination of a food-frequency questionnaire and two 24 hour recalls)
measure: Glycemia
time frame: At the end of the intervention which is 23 weeks after baseline
description: Plasma glucose levels in gestational week 37 minus plasma glucose levels in gestational week 14
measure: Maternal body fatness post partum
time frame: One week post partum
description: Maternal body fatness 1 week post partum
measure: Infant body fatness
time frame: One week of age
description: Infant body fatness at 1 week of age
arm group label: Mobile phone based intervention
arm group type: Experimental
description: This group will receive the smartphone app HealthyMoms between gestational week 14 and 37. The app will contain information and support to achieve a healthy weight gain and lifestyle during pregnancy. This group will also receive standard care.
arm group label: Control
arm group type: No Intervention
description: This group will only receive standard care.
intervention type: Behavioral
intervention name: Mobile phone based intervention
description: Participants in the intervention group will receive a 6-month mobile phone based program via a mobile phone application specifically designed for this study. The program will include information, advice and strategies to promote healthy gestational weight gain.
arm group label: Mobile phone based intervention
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marie Löf, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Marie Löf, docent
investigator title: Senior researcher, associate professor
mesh term: Body Weight
mesh term: Weight Gain
sharing ipd: No