Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01693536




Registration number
NCT01693536
Ethics application status
Date submitted
16/09/2012
Date registered
26/09/2012
Date last updated
26/09/2012

Titles & IDs
Public title
Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial
Scientific title
Effective Change of Behaviour of the Elderly in Normal General Practice
Secondary ID [1] 0 0
RO783
Universal Trial Number (UTN)
Trial acronym
ECOBEING
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health Behaviour 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Lifestyle counselling

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.

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.


Behaviour: Lifestyle counselling
as in Arm Description
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the change in morning urine sodium/potassium ratio
Timepoint [1] 0 0
between enrollment and six months
Primary outcome [2] 0 0
the increased distance in a six minute walk test
Timepoint [2] 0 0
between enrollment and six months
Secondary outcome [1] 0 0
change in systolic BP
Timepoint [1] 0 0
between enrollment and six months
Secondary outcome [2] 0 0
change in doses/day of antihypertensive medication
Timepoint [2] 0 0
between enrollment and six months
Secondary outcome [3] 0 0
change in waist measurement
Timepoint [3] 0 0
between enrollment and six months
Secondary outcome [4] 0 0
change in weight & BMI
Timepoint [4] 0 0
between enrollment and six months
Secondary outcome [5] 0 0
change in cognition measurement
Timepoint [5] 0 0
between enrollment and six months

Eligibility
Key inclusion criteria
- Living independently

- Must be able to walk for six minutes
Minimum age
75 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Dementia as defined by Standardised Mini-Mental State Examination score <25/30

- All patients of HealthHQ-Southport General Practice

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Health HQ-Southport General Practice - Southport
Recruitment postcode(s) [1] 0 0
4215 - Southport

Funding & Sponsors
Primary sponsor type
Other
Name
Health HQ
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01693536
Trial related presentations / publications
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.
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.
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
Public notes

Contacts
Principal investigator
Name 0 0
Norman A Hohl, MBBS, FRACGP
Address 0 0
Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01693536