<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/NCT02223234</url>
  </required_header>
  <id_info>
    <org_study_id>14AP008</org_study_id>
    <nct_id>NCT02223234</nct_id>
  </id_info>
  <brief_title>Guelph Family Health Study: Pilot Study</brief_title>
  <official_title>Guelph Family Health Study: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guelph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Guelph</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of the proposed study is to test, among Canadian families, the&#xD;
      comparative effectiveness of 2 different versions (doses) of a family-based obesity&#xD;
      prevention intervention that is tailored to families' behavioural risk profile.&#xD;
&#xD;
      To achieve this objective, we will conduct a randomized controlled trial of families with&#xD;
      children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1)&#xD;
      Monthly emails with general health information (Attention Control), 2) Tailored weekly emails&#xD;
      and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home&#xD;
      visits (Email +4). The intervention will last 6 months, with follow-up at 12-months&#xD;
      post-intervention (18 months from baseline). We will examine the impact of the intervention&#xD;
      on the children's body composition, weight-related behaviours, and biomarkers of diabetes and&#xD;
      cardiovascular disease risk.&#xD;
&#xD;
      We hypothesize that, compared to children in the Attention Control, children in the Email +2&#xD;
      and Email +4 conditions will achieve:&#xD;
&#xD;
        1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass&#xD;
           index (BMI),over a 6-month intervention period.&#xD;
&#xD;
        2. higher frequency of family meals, child's sleep duration, physical activity, and fruit&#xD;
           and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary&#xD;
           behaviour over a 6-month intervention period. (secondary outcomes)&#xD;
&#xD;
        3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting&#xD;
           insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein,&#xD;
           trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a&#xD;
           6-month intervention period.&#xD;
&#xD;
      We further hypothesize that there will be no significant difference in these outcomes between&#xD;
      children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in adiposity</measure>
    <time_frame>baseline, 6 month follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in body mass index</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in waist circumference</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in frequency of family meals</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in child's sleep duration</measure>
    <time_frame>baseline, 6-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in child's physical activity</measure>
    <time_frame>baseline, 6-months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in child's fruit and vegetable intake</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in child's sugar-sweetened beverage intake</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in sedentary behaviour</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in child's diastolic blood pressure</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in child's biomarkers of diabetes and cardiovascular disease risk</measure>
    <time_frame>baseline, 6-month follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control- monthly mailed information on children's health</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Email and 4 Home Visits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly emails and 4 home visits with a health educator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Email and 2 Home Visits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly emails and 2 home visits</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emails and 4 Home Visits</intervention_name>
    <description>Weekly emails and 4 home visits with health educator</description>
    <arm_group_label>Email and 4 Home Visits</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Monthly emails on child health</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emails and 2 home visits</intervention_name>
    <description>Weekly emails and 2 home visits with health educator</description>
    <arm_group_label>Email and 2 Home Visits</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  families who have a child aged 18 months through 5 years&#xD;
&#xD;
          -  live the Guelph area&#xD;
&#xD;
          -  have a parent who can respond to questionnaires in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  families who plan to move during the study period&#xD;
&#xD;
          -  children with severe health conditions (such as severe cerebral palsy) that would&#xD;
             prohibit them from participating in study activities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Univeristy of Guelph</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G 2W1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Guelph</investigator_affiliation>
    <investigator_full_name>Jess Haines</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02223234
org study id: 14AP008
nct id: NCT02223234
lead sponsor: 
has dmc: No
The overall objective of the proposed study is to test, among Canadian families, the
      comparative effectiveness of 2 different versions (doses) of a family-based obesity
      prevention intervention that is tailored to families' behavioural risk profile.

      To achieve this objective, we will conduct a randomized controlled trial of families with
      children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1)
      Monthly emails with general health information (Attention Control), 2) Tailored weekly emails
      and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home
      visits (Email +4). The intervention will last 6 months, with follow-up at 12-months
      post-intervention (18 months from baseline). We will examine the impact of the intervention
      on the children's body composition, weight-related behaviours, and biomarkers of diabetes and
      cardiovascular disease risk.

      We hypothesize that, compared to children in the Attention Control, children in the Email +2
      and Email +4 conditions will achieve:

        1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass
           index (BMI),over a 6-month intervention period.

        2. higher frequency of family meals, child's sleep duration, physical activity, and fruit
           and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary
           behaviour over a 6-month intervention period. (secondary outcomes)

        3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting
           insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein,
           trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a
           6-month intervention period.

      We further hypothesize that there will be no significant difference in these outcomes between
      children in the conditions with 2 (Email +2) or 4 (Email +4) home visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: change in adiposity
time frame: baseline, 6 month follow-up
measure: change in body mass index
time frame: baseline, 6-month follow-up
measure: change in waist circumference
time frame: baseline, 6-month follow-up
measure: change in frequency of family meals
time frame: baseline, 6-month follow-up
measure: change in child's sleep duration
time frame: baseline, 6-months
measure: change in child's physical activity
time frame: baseline, 6-months
measure: change in child's fruit and vegetable intake
time frame: baseline, 6-month follow-up
measure: change in child's sugar-sweetened beverage intake
time frame: baseline, 6-month follow-up
measure: change in sedentary behaviour
time frame: baseline, 6-month follow-up
measure: change in child's diastolic blood pressure
time frame: baseline, 6-month follow-up
measure: change in child's biomarkers of diabetes and cardiovascular disease risk
time frame: baseline, 6-month follow-up
arm group label: Control
arm group type: Active Comparator
description: Control- monthly mailed information on children's health
arm group label: Email and 4 Home Visits
arm group type: Experimental
description: Weekly emails and 4 home visits with a health educator
arm group label: Email and 2 Home Visits
arm group type: Experimental
description: Weekly emails and 2 home visits
intervention type: Behavioral
intervention name: Emails and 4 Home Visits
description: Weekly emails and 4 home visits with health educator
arm group label: Email and 4 Home Visits
intervention type: Behavioral
intervention name: Control
description: Monthly emails on child health
arm group label: Control
intervention type: Behavioral
intervention name: Emails and 2 home visits
description: Weekly emails and 2 home visits with health educator
arm group label: Email and 2 Home Visits
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Guelph
investigator full name: Jess Haines
investigator title: Associate Professor