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Health BehaviourECOBEINGNCT01693536

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

A study testing Lifestyle counselling in people with Health Behaviour, run by Health HQ at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 75 to 95 yearsHealthy volunteers can take part
Conditions the study is for
Health Behaviour
What is being tested?
Lifestyle counselling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteAustralia
Study dates
Oct 2008to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 to 95 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Health HQ-Southport General Practice

    Southport, Queensland, 4215

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
Lifestyle counselling
Keywords
Elderly, Sodium reduction, Fitness increase, Primary Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle counsellingBehavioural

    Also called salt reduction in the elderly, increased fitness in the elderly

    as in Arm Description

Study groups in NCT01693536
Study groupRoleWhat they receive
Lifestyle counsellingExperimentalThree dietician visits focussed on education to find food with sodium less than 120mg/100gms. Two physiotherapist visits focussed on teaching personalised sustainable practical exercise.
Receives: Behavioral: Lifestyle counselling
ControlNo interventionControl group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change in morning urine sodium/potassium ratio

    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.

    Measured: between enrollment and six months

  2. the increased distance in a six minute walk test

    to measure objectively an increase in fitness the increase in the six minute walk test was used

    Measured: between enrollment and six months

Secondary outcomes (5)

  1. change in systolic BP

    teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome

    Measured: between enrollment and six months

  2. change in doses/day of antihypertensive medication

    teaching reduction in sodium and increased fitness may mean people need less antihypertensive medication as a secondary outcome

    Measured: between enrollment and six months

  3. change in waist measurement

    teaching increased fitness would be expected to reduce waist measurement as a secondary outcome

    Measured: between enrollment and six months

  4. change in weight & BMI

    teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome

    Measured: between enrollment and six months

  5. change in cognition measurement

    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.

    Measured: between enrollment and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2012 (estimated)
  2. Study startOct 2008
  3. Primary completionJul 2009
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01693536
Sponsor's protocol ID
RO783
Acronym
ECOBEING
Status last verified
Sep 2012
First submitted
16 Sep 2012
Last updated
26 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17449506

  • 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.

    PubMed 17098085

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle counselling in people with Health Behaviour, run by Health HQ at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change in morning urine sodium/potassium ratio (time frame: between enrollment and six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01693536, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.

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