- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02105727
Changing Population Salt Consumption in Lithgow, Australia
A Before After Comparison of the Effectiveness of a Community-based Salt Reduction Program Done in Lithgow, Australia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The primary objective of this project is to determine whether there have been changes in average salt consumption levels in the Lithgow population from 2011 to 2014. The primary null hypothesis to be tested is that there will be no difference between the mean 24-hour urinary sodium excretion levels between 2011 and 2014.
The sample of 419 individuals with 24-hour urine samples in the baseline survey and 600 individuals in the follow-up survey will provide 80% power to detect a difference of 0.7 g/day salt between the mean levels of excretion before and after the intervention. There will be more than 95% power to detect a difference of 1.0 g/day salt or greater.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- The George Institute for Global Health
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All adults over the age of 20 years residing in the Lithgow area are eligible
- No exclusion based on inter-current illness, use of medications or any other aspect of demography or personal history.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Salt reduction
Community-based salt reduction
|
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Urinary sodium excretion (mmol/l)
Periodo de tiempo: up to 4 years
|
A single 24-hour urine collection will be obtained with the first voided urine upon waking on the day of collection being discarded and participants then collecting all voided urine up to and including the first void the following morning.
The times at the beginning and the end of urine collection are recorded.
|
up to 4 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sources of sodium
Periodo de tiempo: up to 4 years
|
The multiple pass 24-hour dietary recall is used to determine all food and beverages consumed from midnight to midnight on the day before the interview, this method has been described in detail by prior reports.
Food model booklets are used to assist with the reporting of quantity and prompts provided by interviewers are used to probe for complete food descriptions, variable recipe ingredients, and food preparation including salt added during cooking and at the table.
Dietary data are entered into the nutrient analysis package FoodWorks Professional version 7. The food coding guidelines are used to code each food and beverage into major, sub-major and minor food categories.
|
up to 4 years
|
Knowledge, attitudes and behaviors towards salt intake
Periodo de tiempo: up to 4 years
|
The measurement of knowledge attitude and behaviors towards salt is based upon a questionnaire adapted from the World Health Organization/Pan American Health Organization protocol for population level sodium determination.
The questionnaire contains nine questions; four related to knowledge of personal consumption, recommended daily intake and possible harmful effects of salt and five assessing attitudes and behaviors to lowering salt intake.
|
up to 4 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Urinary iodine excretion (ug/l)
Periodo de tiempo: up to 4 years
|
UIE will be assessed in the spot urine samples of females aged 20-45 years old.
The measurement will be completed by using ammonium persulfate digestion prior to Sandell-Koltoff reaction in a microtitre plate format.
|
up to 4 years
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Land MA, Webster J, Christoforou A, Johnson C, Trevena H, Hodgins F, Chalmers J, Woodward M, Barzi F, Smith W, Flood V, Jeffery P, Nowson C, Neal B. The association of knowledge, attitudes and behaviours related to salt with 24-hour urinary sodium excretion. Int J Behav Nutr Phys Act. 2014 Apr 4;11(1):47. doi: 10.1186/1479-5868-11-47.
- Land MA, Webster J, Christoforou A, Praveen D, Jeffery P, Chalmers J, Smith W, Woodward M, Barzi F, Nowson C, Flood V, Neal B. Salt intake assessed by 24 h urinary sodium excretion in a random and opportunistic sample in Australia. BMJ Open. 2014 Jan 16;4(1):e003720. doi: 10.1136/bmjopen-2013-003720.
- Land MA, Jeffery P, Webster J, Crino M, Chalmers J, Woodward M, Nowson C, Smith W, Flood V, Neal B. Protocol for the implementation and evaluation of a community-based intervention seeking to reduce dietary salt intake in Lithgow, Australia. BMC Public Health. 2014 Apr 14;14:357. doi: 10.1186/1471-2458-14-357.
- Land MA, Wu JH, Selwyn A, Crino M, Woodward M, Chalmers J, Webster J, Nowson C, Jeffery P, Smith W, Flood V, Neal B. Effects of a community-based salt reduction program in a regional Australian population. BMC Public Health. 2016 May 11;16:388. doi: 10.1186/s12889-016-3064-3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2014079
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Community-based salt reduction
-
University Hospital, BordeauxTerminadoEnfermedad de ParkinsonFrancia
-
Universidad de GranadaChair in Conscience and Development (UGR); Mind, Brain and Behaviour Research...TerminadoAnsiedad | Trastorno sicologico | Perfeccionismo | Atención | Empatía | Creatividad | Estrés de la vida | Inteligencia emocionalEspaña