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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle counselling | Behavioral | as in Arm Description |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in systolic BP | teaching people to reduce sodium intake and increase fitness may reduce systolic blood pressure as a secondary outcome | between enrollment and six months |
| change in doses/day of antihypertensive medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health HQ-Southport General Practice | Southport | Queensland | 4215 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17449506 | Background | 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. | |
| 17098085 |
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teaching reduction in sodium and increased fitness may mean people need less antihypertensive medication as a secondary outcome
| between enrollment and six months |
| change in waist measurement | teaching increased fitness would be expected to reduce waist measurement as a secondary outcome | between enrollment and six months |
| change in weight & BMI | teaching increased fitness would be expected to reduce weight and therefore calculated Body Mass Index as a secondary outcome | between enrollment and six months |
| change in cognition measurement | 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. | between enrollment and six months |
| 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. |
| Background | 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 |