Cost-effectiveness of nutritional supplementation and exercise programme among older people in Santiago, Chile
| ISRCTN | ISRCTN48153354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48153354 |
| Secondary identifying numbers | 075219 |
- Submission date
- 25/01/2005
- Registration date
- 22/07/2005
- Last edited
- 31/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
This study aims to evaluate the cost-effectiveness of a national nutrition supplementation programme and a specially designed physical exercise intervention for older people. The aim is to find out whether the nutritional supplement decreases the incidence of pneumonia and whether the exercise increases walking capacity (i.e., the distance they are able to walk in six minutes).
Who can participate?
Adults aged 65 - 67.9 years, living in low to middle socioeconomic circumstances, and attending the participating health centres.
What does the study involve?
Participating health centres are randomly allocated to one of four groups, to deliver to their patients either the daily nutritional supplement, two 1-hour physical activity classes per week, both interventions or neither for 24 months. The researchers assess the incidence of pneumonia and walking capacity. The researchers also use administrative records and interviews with staff and patients to estimate the cost-effectiveness of the interventions.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
The Chilean Ministry of Health (Chile)
When is the study starting and how long is it expected to run for?
August 2005 to November 2007
Who is funding the study?
1. The Wellcome Trust (UK)
2. Chilean Ministry of Health (Chile)
Who is the main contact?
Prof. Ricardo Uauy
ricardo.uauy@lshtm.ac.uk
Contact information
Scientific
London School of Hygiene and Tropical Medicine
NPHIRU/EPH
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7958 8126 |
|---|---|
| ricardo.uauy@lshtm.ac.uk |
Study information
| Study design | Factorial cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Cost-Effectiveness of Nutritional supplementation and EXercise programme among older people in Santiago, Chile |
| Study acronym | CENEX-Chile |
| Study objectives | 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. |
| Ethics approval(s) | 1. Institute of Nutrition and Food Technology (Instituto de Nutrición y Tecnología de los Alimentos [INTA[), University of Chile, 08/08/2005, ref: 3040 2. Ministry of Health, Chile 3. The London School of Hyiene and Tropical Medicine (LSHTM), University of London, 08/08/2005, ref: Acta de Aprobación No.9/2005 |
| Health condition(s) or problem(s) studied | Pneumonia and physical functional decline |
| Intervention | 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 |
| Intervention type | Mixed |
| Primary outcome measure | Current information as of 22/09/2010: 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 measures | Added 22/09/2010 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) |
| Overall study start date | 01/08/2005 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 2800 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Chile
- England
- United Kingdom
Study participating centre
WC1E 7HT
United Kingdom
Sponsor information
University/education
Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 (0)20 7827 2678 |
|---|---|
| penny.ireland@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Government
Private sector organisation / International organizations
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/07/2007 | Yes | No | |
| Protocol article | protocol | 27/05/2009 | Yes | No | |
| Results article | results | 01/04/2011 | Yes | No | |
| Results article | results | 01/04/2013 | Yes | No | |
| Other publications | secondary outcome analysis | 09/09/2013 | Yes | No | |
| Results article | results | 24/07/2017 | Yes | No |
Editorial Notes
31/07/2017: Publication reference added.
04/02/2016: Plain English summary added.
