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

NCT ID: NCT01693536

Last Updated: 2012-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Health Behaviour

Keywords

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Elderly Sodium reduction Fitness increase Primary Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lifestyle counselling

Intervention Type BEHAVIORAL

as in Arm Description

Control

Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle counselling

as in Arm Description

Intervention Type BEHAVIORAL

Other Intervention Names

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salt reduction in the elderly increased fitness in the elderly

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health HQ

OTHER

Sponsor Role lead

Responsible Party

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Norman Hohl

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Norman A Hohl, MBBS, FRACGP

Role: PRINCIPAL_INVESTIGATOR

Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science

Chris del Mar, FAFPHM,MD,MA

Role: STUDY_CHAIR

Dean BOND Uni Faculty Health Science & Medicine (at time of study)

Locations

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Health HQ-Southport General Practice

Southport, Queensland, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type BACKGROUND
PMID: 17449506 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17098085 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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RO783

Identifier Type: -

Identifier Source: org_study_id