Can Primary Care Change Elderly Physical Activity and Salt Intake? An Australian Pilot Trial (ECOBEING)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norman Hohl, Health HQ
ClinicalTrials.gov Identifier:
NCT01693536
First received: September 16, 2012
Last updated: September 22, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Health Behaviour
Behavioral: Lifestyle counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effective Change of Behaviour of the Elderly in Normal General Practice

Resource links provided by NLM:


Further study details as provided by Health HQ:

Primary Outcome Measures:
  • the change in morning urine sodium/potassium ratio [ Time Frame: between enrollment and six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    to measure objectively an increase in fitness the increase in the six minute walk test was used


Secondary Outcome Measures:
  • change in systolic BP [ Time Frame: between enrollment and six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 85
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • salt reduction in the elderly
  • increased fitness in the elderly
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.

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

Ages Eligible for Study:   75 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693536

Locations
Australia, Queensland
Health HQ-Southport General Practice
Southport, Queensland, Australia, 4215
Sponsors and Collaborators
Health HQ
Investigators
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)