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22 May 2013
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| [ Print-friendly version ] |
| Cost-Effectiveness of Nutritional supplementation and EXercise programme among older people in Santiago, Chile |
| ISRCTN | ISRCTN48153354 |
| DOI | 10.1186/ISRCTN48153354 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Cost-Effectiveness of Nutritional supplementation and EXercise programme among older people in Santiago, Chile |
| Scientific title | |
| Acronym | CENEX-Chile |
| Serial number at source | 075219 |
| Study hypothesis |
This project aims to evaluate the cost-effectiveness of a national nutrition supplementation programme, and a specially designed physical exercise intervention for older people. The study has been conceptualised as a public health programme effectiveness study and has been designed as a full-factorial cluster-randomised trial.
The two study hypotheses are: 1. Provision at health centres of a fortified nutritional supplement for two years to adults aged 65.0 to 67.9 years at baseline will decrease the incidence of pneumonia among individuals to whom the programme is provided 2. Provision of a community-based, twice-weekly resistance training exercise programme for two years to adults aged 65.0 to 67.9 years at baseline will increase walking capacity among individuals to whom the programme is provided The main outcomes are incidence of pneumonia and change in walking capacity. Costing data (user and provider), collected at all levels, will enable the determination of the cost-effectiveness of the two interventions individually and in combination. Please note that as of 22/09/10 this record has been updated. Further details may be found in the relevant field with the above update date. |
| Lay summary | Lay summary under review 3 |
| Ethics approval |
Added 22/09/10:
1. Institute of Nutrition and Food Technology (Instituto de Nutrición y Tecnología de los Alimentos [INTA[), University of Chile approved on the 8th of August 2005 (ref: 3040) 2. Ministry of Health, Chile 3. The London School of Hyiene and Tropical Medicine (LSHTM), University of London approved on the 8th of August 2005 (ref: Acta de Aprobación No.9/2005) |
| Study design | Factorial cluster randomised controlled trial |
| Countries of recruitment | Chile |
| Disease/condition/study domain | Pneumonia and physical functional decline |
| Participants - inclusion criteria |
1. Aged 65.0 to 67.9 at baseline
2. Living in the catchment area of one of 28 selected health centres of low/medium socio-economic status in Santiago, Chile |
| Participants - exclusion criteria |
1. Non-ambulatory
2. Recent un-explained weight loss (more than 3 kg in past three months) 3. Possible clinical dementia (as assessed via mini-mental state examination) |
| Anticipated start date | 01/08/2005 |
| Anticipated end date | 01/11/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 2800 - recruitment ends on 31st May 2006 |
| Interventions |
The study has been designed as a full-factorial cluster-randomised trial. There will be 28 clusters which are defined as health centre catchment areas, and 100 individuals will be randomly selected from each cluster. The total study sample size will be 2800 individuals.
20 of the clusters will be randomly assigned to one of the four study arms; the remaining eight clusters will be randomly assigned to either the nutritional supplement or the control arm. The four study interventions are: 1. Provision at the local health centre of monthly supplies of micronutrient fortified nutritional supplements (powdered vegetable and legume mix, and powdered milk drink) for 24 months 2. Provision of two one hour-long exercise classes a week for 24 months at local community centres 3. Both one and two above 4. Neither one nor two above |
| Primary outcome measure(s) |
Current information as of 22/09/10:
1. For nutrition intervention: The incidence of pneumonia over the 24 months after the initiation of the intervention. 2. For exercise intervention: Walking capacity (distance walked in six minutes) 24 months after initiation of the intervention. Initial information at time of registration: 1. Incidence of pneumonia over 24 months of intervention and subsequent six months 2. Change in walking capacity over 24 months of intervention 3. Change in body mass index over 24 months of intervention |
| Secondary outcome measure(s) |
Added 22/09/10
1. Body mass index 2. Incidence of acute respiratory infection 3. Self-reported health status (Short-Form 36) 4. Depression, assessed bt Geriatric Depression Scale (GDS-15) 5. Self-reported incidence of chronic diseases 6. Physical and functional limitations 7. Self reported productive activity 8. Self-reported incidence of falls 9. Self-reported incidence of fracture 10. Blood pressure 11. Anthropometry 12. Timed up-and-go assessment 13. Blood indicators of cardiovascular disease risk and insulin resistance (in a sub-sample) |
| Sources of funding |
1. The Wellcome Trust (UK) (grant ref: 075219)
2. The Ministry of Health (Chile) (in kind contribution) |
| Trial website | |
| Publications |
1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17615064
2. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19473513 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21526229 |
| Contact name | Prof Ricardo Uauy |
| Address |
London School of Hygiene and Tropical Medicine
NPHIRU/EPH Keppel Street |
| City/town | London |
| Zip/Postcode | WC1E 7HT |
| Country | United Kingdom |
| Tel | +44 (0)20 7958 8126 |
| Fax | +44 (0)20 7958 8133 |
| ricardo.uauy@lshtm.ac.uk | |
| Sponsor | London School of Hygiene and Tropical Medicine (UK) |
| Address |
Research Grants and Contracts Office
Keppel Street |
| City/town | London |
| Zip/Postcode | WC1E 7HT |
| Country | United Kingdom |
| Tel | +44 (0)20 7827 2678 |
| Fax | +44 (0)20 7927 5636 |
| penny.ireland@lshtm.ac.uk | |
| Sponsor website: | http://www.lshtm.ac.uk |
| Date applied | 25/01/2005 |
| Last edited | 09/05/2013 |
| Date ISRCTN assigned | 22/07/2005 |
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