NCT01693536

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
Last Updated

September 26, 2012

Status Verified

September 1, 2012

Enrollment Period

9 months

First QC Date

September 16, 2012

Last Update Submit

September 22, 2012

Conditions

Health Behaviour

Keywords

ElderlySodium reductionFitness increasePrimary Care

Outcome Measures

Primary Outcomes (2)

  • the change in morning urine sodium/potassium ratio

    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.

    between enrollment and six months

  • the increased distance in a six minute walk test

    to measure objectively an increase in fitness the increase in the six minute walk test was used

    between enrollment and six months

Secondary Outcomes (5)

  • change in systolic BP

    between enrollment and six months

  • change in doses/day of antihypertensive medication

    between enrollment and six months

  • change in waist measurement

    between enrollment and six months

  • change in weight & BMI

    between enrollment and six months

  • change in cognition measurement

    between enrollment and six months

Study Arms (2)

Lifestyle counselling

EXPERIMENTAL

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

Control

NO INTERVENTION

Control group was offered free skin cancer check and wait listed for the same lifestyle counselling after the six months of the study.

Interventions

Lifestyle counsellingBEHAVIORAL

as in Arm Description

Also known as: salt reduction in the elderly, increased fitness in the elderly
Lifestyle counselling

Eligibility Criteria

Age75 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Living independently
  • Must be able to walk for six minutes

You may not qualify if:

  • Dementia as defined by Standardised Mini-Mental State Examination score \<25/30
  • All patients of HealthHQ-Southport General Practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health HQ-Southport General Practice

Southport, Queensland, 4215, Australia

Location

Related Publications (3)

  • 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.

    PMID: 17449506BACKGROUND

  • 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.

    PMID: 17098085BACKGROUND

  • 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

    BACKGROUND

Study Officials

  • Norman A Hohl, MBBS, FRACGP

    Medical Director Health HQ, Ass Prof Bond Uni Faculty Health Science

    PRINCIPAL INVESTIGATOR

  • Chris del Mar, FAFPHM,MD,MA

    Dean BOND Uni Faculty Health Science & Medicine (at time of study)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

September 16, 2012

First Posted

September 26, 2012

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

December 1, 2010

Last Updated

September 26, 2012

Record last verified: 2012-09

Locations

AU(1)