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

Health Behaviour Clinical Trial

— ECOBEING  

Official title:

Effective Change of Behaviour of the Elderly in Normal General Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693536
• Other study ID #: RO783
• Status: Completed
• Phase: N/A
• First received: September 16, 2012
• Last updated: September 22, 2012
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2012
• Source: Health HQ
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Health Behaviour

Intervention

Behavioral:
• Lifestyle counselling
as in Arm Description

Locations

Country	Name	City	State
Australia	Health HQ-Southport General Practice	Southport	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Health HQ

Country where clinical trial is conducted

Australia, 

References & Publications (3)

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. Epub 2007 Apr 20. — View 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

Lindström J, Ilanne-Parikka P, Peltonen M, Aunola S, Eriksson JG, Hemiö K, Hämäläinen H, Härkönen P, Keinänen-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	between enrollment and six months	No
Primary	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	between enrollment and six months	No
Secondary	change in systolic BP	teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome	between enrollment and six months	No
Secondary	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	between enrollment and six months	No
Secondary	change in waist measurement	teaching increased fitness would be expected to reduce waist measurement as a secondary outcome	between enrollment and six months	No
Secondary	change in weight & BMI	teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome	between enrollment and six months	No
Secondary	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.	between enrollment and six months	No