Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial (ECOBEING)
|ClinicalTrials.gov Identifier: NCT01693536|
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Health Behaviour||Behavioral: Lifestyle counselling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effective Change of Behaviour of the Elderly in Normal General Practice|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||December 2010|
Experimental: 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.
Behavioral: Lifestyle counselling
as in Arm Description
No Intervention: Control
Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.
- the change in morning urine sodium/potassium ratio [ Time Frame: between enrollment and six months ]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.
- the increased distance in a six minute walk test [ Time Frame: between enrollment and six months ]to measure objectively an increase in fitness the increase in the six minute walk test was used
- change in systolic BP [ Time Frame: between enrollment and six months ]teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome
- change in doses/day of antihypertensive medication [ Time Frame: between enrollment and six months ]teaching reduction in sodium and increased fitness may mean people need less antihypertensive medication as a secondary outcome
- change in waist measurement [ Time Frame: between enrollment and six months ]teaching increased fitness would be expected to reduce waist measurement as a secondary outcome
- change in weight & BMI [ Time Frame: between enrollment and six months ]teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome
- change in cognition measurement [ Time Frame: between enrollment and six months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693536
|Health HQ-Southport General Practice|
|Southport, Queensland, Australia, 4215|
|Principal Investigator:||Norman A Hohl, MBBS, FRACGP||Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science|
|Study Chair:||Chris del Mar, FAFPHM,MD,MA||Dean BOND Uni Faculty Health Science & Medicine (at time of study)|