Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial (ECOBEING)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|