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Completed

NCT Number: NCT01693536

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

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.

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Key information

Conditions

Health Behaviour

Age range

75 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health HQ-Southport General Practice

Southport, Queensland, 4215, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle counselling

Behavioral

as in Arm Description

Other names: salt reduction in the elderly, increased fitness in the elderly

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Health HQ

Other

Registry information

Official study title

Effective Change of Behaviour of the Elderly in Normal General Practice

Acronym: ECOBEING

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 26, 2012
Registry last updated
Sep 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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