An interventional study of Lifestyle counselling in Health Behaviour, sponsored by Health HQ. Completed at 1 site in Australia. Open to participants aged 75 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-09-26.
Sponsored by Health HQ · Not applicable, Interventional, and Prevention
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.
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.
This is the only study on the registry with Health HQ as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Lifestyle counselling
Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.
as in Arm Description
Also known as: salt reduction in the elderly, increased fitness in the elderly
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.
Time frame: between enrollment and six months
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
Time frame: between enrollment and six months
change in systolic BP
teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome
Time frame: between enrollment and six months
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
Time frame: between enrollment and six months
change in waist measurement
teaching increased fitness would be expected to reduce waist measurement as a secondary outcome
Time frame: between enrollment and six months
change in weight & BMI
teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome
Time frame: between enrollment and six months
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.
Time frame: between enrollment and six months
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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