Clinical trial NCT01693536: Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial
Official title: Effective Change of Behaviour of the Elderly in Normal General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behaviour
Keywords: Elderly
Sodium reduction
Fitness increase
Primary Care
Lead sponsor: Health HQ
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 85
Sex: ALL
Minimum age (years): 75
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: the change in morning urine sodium/potassium ratio
timeFrame: between enrollment and six months
measure: the increased distance in a six minute walk test
timeFrame: between enrollment and six months
Secondary outcomes:
measure: change in systolic BP
timeFrame: between enrollment and six months
measure: change in doses/day of antihypertensive medication
timeFrame: between enrollment and six months
measure: change in waist measurement
timeFrame: between enrollment and six months
measure: change in weight & BMI
timeFrame: between enrollment and six months
measure: change in cognition measurement
timeFrame: between enrollment and six months
Other outcomes:
Locations:
city: Southport
country: Australia
facility: Health HQ-Southport General Practice
state: Queensland
Study officials:
affiliation: Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science
name: Norman A Hohl, MBBS, FRACGP
role: PRINCIPAL_INVESTIGATOR
affiliation: Dean BOND Uni Faculty Health Science & Medicine (at time of study)
name: Chris del Mar, FAFPHM,MD,MA
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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