Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial (ECOBEING)

September 22, 2012 updated by: Norman Hohl, Health HQ

Effective Change of Behaviour of the Elderly in Normal General Practice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Health HQ-Southport General Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 95 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Living independently
  • Must be able to walk for six minutes

Exclusion Criteria:

  • Dementia as defined by Standardised Mini-Mental State Examination score <25/30
  • All patients of HealthHQ-Southport General Practice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle counselling

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.
Behavioral: Lifestyle counselling
as in Arm Description
Other Names:
  • salt reduction in the elderly
  • increased fitness in the elderly
No Intervention: Control
Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change in morning urine sodium/potassium ratio
Time Frame: between enrollment and six months
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.
between enrollment and six months
the increased distance in a six minute walk test
Time Frame: between enrollment and six months
to measure objectively an increase in fitness the increase in the six minute walk test was used
between enrollment and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in systolic BP
Time Frame: between enrollment and six months
teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome
between enrollment and six months
change in doses/day of antihypertensive medication
Time Frame: between enrollment and six months
teaching reduction in sodium and increased fitness may mean people need less antihypertensive medication as a secondary outcome
between enrollment and six months
change in waist measurement
Time Frame: between enrollment and six months
teaching increased fitness would be expected to reduce waist measurement as a secondary outcome
between enrollment and six months
change in weight & BMI
Time Frame: between enrollment and six months
teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome
between enrollment and six months
change in cognition measurement
Time Frame: between enrollment and six months
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.
between enrollment and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health HQ

Investigators

  • Principal Investigator: Norman A Hohl, MBBS, FRACGP, Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science
  • Study Chair: Chris del Mar, FAFPHM,MD,MA, Dean BOND Uni Faculty Health Science & Medicine (at time of study)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 16, 2012

First Submitted That Met QC Criteria

September 22, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 22, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RO783

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Health Behaviour

Clinical Trials on Lifestyle counselling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe