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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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)