<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/NCT01693536</url>
  </required_header>
  <id_info>
    <org_study_id>RO783</org_study_id>
    <nct_id>NCT01693536</nct_id>
  </id_info>
  <brief_title>Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial</brief_title>
  <acronym>ECOBEING</acronym>
  <official_title>Effective Change of Behaviour of the Elderly in Normal General Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health HQ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Health HQ</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomised controlled trial to test if offering three visits to a dietician + two visits to&#xD;
      a physiotherapist over six months + a home sphygmomanometer, will result in a reduction in&#xD;
      sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled from&#xD;
      Oct 2008 to July 2009.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is evidence that both sedentary lifestyle and high sodium diets contribute to&#xD;
      cardiovascular disease and possibly dementia among the elderly. There is a need to show that&#xD;
      minimal intervention can reduce sodium intake and increase fitness in the elderly. Finland&#xD;
      has shown that five dietician visits/year could change diet in respect to fat and fibre. In&#xD;
      Australia the National Health Insurer (Medicare) funds five allied health visits/year for&#xD;
      those with chronic disease, hence our use of this model. This is consistent with WHO&#xD;
      guidelines for a national approach using existing health infrastructure. The elderly&#xD;
      (75-95yrs) were chosen as this group is thought most difficult to change behaviour and has a&#xD;
      higher incidence of dementia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <completion_date type="Actual">December 2010</completion_date>
  <primary_completion_date type="Actual">July 2009</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>the change in morning urine sodium/potassium ratio</measure>
    <time_frame>between enrollment and six months</time_frame>
    <description>this measure is to reflect sodium intake. A 24hr urinary sodium cannot be readily validated as an accurate collection and even in the Trials of Hypertension Prevention study was changed to 8hrs to assist compliance. A spot morning ratio is a useful marker of sodium intake for group evaluation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the increased distance in a six minute walk test</measure>
    <time_frame>between enrollment and six months</time_frame>
    <description>to measure objectively an increase in fitness the increase in the six minute walk test was used</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in systolic BP</measure>
    <time_frame>between enrollment and six months</time_frame>
    <description>teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in doses/day of antihypertensive medication</measure>
    <time_frame>between enrollment and six months</time_frame>
    <description>teaching reduction in sodium and increased fitness may mean people need less antihypertensive medication as a secondary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in waist measurement</measure>
    <time_frame>between enrollment and six months</time_frame>
    <description>teaching increased fitness would be expected to reduce waist measurement as a secondary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in weight &amp; BMI</measure>
    <time_frame>between enrollment and six months</time_frame>
    <description>teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in cognition measurement</measure>
    <time_frame>between enrollment and six months</time_frame>
    <description>Cognition measurements using the Standardised Mini-Mental State Examination, and the more comprehensive and sensitive Addenbrooke Cognitive Examination to compare those in the intervention group with the highest and lowest quartiles of reduction in sodium intake + increased fitness (equally weighted), as a secondary outcome of teaching these lifestyle changes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Health Behaviour</condition>
  <arm_group>
    <arm_group_label>Lifestyle counselling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three dietician visits focussed on education to find food with sodium less than 120mg/100gms.&#xD;
Two physiotherapist visits focussed on teaching personalised sustainable practical exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle counselling</intervention_name>
    <description>as in Arm Description</description>
    <arm_group_label>Lifestyle counselling</arm_group_label>
    <other_name>salt reduction in the elderly</other_name>
    <other_name>increased fitness in the elderly</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living independently&#xD;
&#xD;
          -  Must be able to walk for six minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia as defined by Standardised Mini-Mental State Examination score &lt;25/30&#xD;
&#xD;
          -  All patients of HealthHQ-Southport General Practice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norman A Hohl, MBBS, FRACGP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chris del Mar, FAFPHM,MD,MA</last_name>
    <role>Study Chair</role>
    <affiliation>Dean BOND Uni Faculty Health Science &amp; Medicine (at time of study)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health HQ-Southport General Practice</name>
      <address>
        <city>Southport</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <reference>
    <citation>Cook NR, Cutler JA, Obarzanek E, Buring JE, Rexrode KM, Kumanyika SK, Appel LJ, Whelton PK. Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP). BMJ. 2007 Apr 28;334(7599):885-8. doi: 10.1136/bmj.39147.604896.55. Epub 2007 Apr 20.</citation>
    <PMID>17449506</PMID>
  </reference>
  <reference>
    <citation>Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006 Nov 11;368(9548):1673-9. doi: 10.1016/S0140-6736(06)69701-8.</citation>
    <PMID>17098085</PMID>
  </reference>
  <reference>
    <citation>Joint Health Surveys Unit (NatCen and UCL). A survey of 24 hour and spot urinary sodium and potassium excretion in a representative sample of the Scottish population. Food Standards Agency Scotland, 2007</citation>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 22, 2012</last_update_submitted>
  <last_update_submitted_qc>September 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Health HQ</investigator_affiliation>
    <investigator_full_name>Norman Hohl</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Sodium reduction</keyword>
  <keyword>Fitness increase</keyword>
  <keyword>Primary Care</keyword>
  <!-- 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/NCT01693536
org study id: RO783
nct id: NCT01693536
lead sponsor: 
has dmc: No
A randomised controlled trial to test if offering three visits to a dietician + two visits to
      a physiotherapist over six months + a home sphygmomanometer, will result in a reduction in
      sodium intake and an increase in fitness in people over 75yrs. Volunteers were enrolled from
      Oct 2008 to July 2009.
There is evidence that both sedentary lifestyle and high sodium diets contribute to
      cardiovascular disease and possibly dementia among the elderly. There is a need to show that
      minimal intervention can reduce sodium intake and increase fitness in the elderly. Finland
      has shown that five dietician visits/year could change diet in respect to fat and fibre. In
      Australia the National Health Insurer (Medicare) funds five allied health visits/year for
      those with chronic disease, hence our use of this model. This is consistent with WHO
      guidelines for a national approach using existing health infrastructure. The elderly
      (75-95yrs) were chosen as this group is thought most difficult to change behaviour and has a
      higher incidence of dementia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: the change in morning urine sodium/potassium ratio
time frame: between enrollment and six months
description: this measure is to reflect sodium intake. A 24hr urinary sodium cannot be readily validated as an accurate collection and even in the Trials of Hypertension Prevention study was changed to 8hrs to assist compliance. A spot morning ratio is a useful marker of sodium intake for group evaluation.
measure: the increased distance in a six minute walk test
time frame: between enrollment and six months
description: to measure objectively an increase in fitness the increase in the six minute walk test was used
measure: change in systolic BP
time frame: between enrollment and six months
description: teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome
measure: change in doses/day of antihypertensive medication
time frame: between enrollment and six months
description: teaching reduction in sodium and increased fitness may mean people need less antihypertensive medication as a secondary outcome
measure: change in waist measurement
time frame: between enrollment and six months
description: teaching increased fitness would be expected to reduce waist measurement as a secondary outcome
measure: change in weight & BMI
time frame: between enrollment and six months
description: teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome
measure: change in cognition measurement
time frame: between enrollment and six months
description: Cognition measurements using the Standardised Mini-Mental State Examination, and the more comprehensive and sensitive Addenbrooke Cognitive Examination to compare those in the intervention group with the highest and lowest quartiles of reduction in sodium intake + increased fitness (equally weighted), as a secondary outcome of teaching these lifestyle changes.
arm group label: Lifestyle counselling
arm group type: Experimental
description: Three dietician visits focussed on education to find food with sodium less than 120mg/100gms.
Two physiotherapist visits focussed on teaching personalised sustainable practical exercise.
arm group label: Control
arm group type: No Intervention
description: Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.
intervention type: Behavioral
intervention name: Lifestyle counselling
description: as in Arm Description
arm group label: Lifestyle counselling
other name: salt reduction in the elderly
other name: increased fitness in the elderly
criteria: 
gender: All
minimum age: 75 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Norman A Hohl, MBBS, FRACGP
role: Principal Investigator
affiliation: Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science
last name: Chris del Mar, FAFPHM,MD,MA
role: Study Chair
affiliation: Dean BOND Uni Faculty Health Science & Medicine (at time of study)
facility: 
country: Australia
citation: Cook NR, Cutler JA, Obarzanek E, Buring JE, Rexrode KM, Kumanyika SK, Appel LJ, Whelton PK. Long term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP). BMJ. 2007 Apr 28;334(7599):885-8. doi: 10.1136/bmj.39147.604896.55. Epub 2007 Apr 20.
PMID: 17449506
citation: Lindstrom J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemio K, Hamalainen H, Harkonen P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Mannelin M, Paturi M, Sundvall J, Valle TT, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group. Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study. Lancet. 2006 Nov 11;368(9548):1673-9. doi: 10.1016/S0140-6736(06)69701-8.
PMID: 17098085
citation: Joint Health Surveys Unit (NatCen and UCL). A survey of 24 hour and spot urinary sodium and potassium excretion in a representative sample of the Scottish population. Food Standards Agency Scotland, 2007
responsible party type: Principal Investigator
investigator affiliation: Health HQ
investigator full name: Norman Hohl
investigator title: Medical Director