Plain English Summary
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. We want 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?
The Wellcome Trust (UK) and the Chilean Ministry of Health (Chile)
Who is the main contact?
Prof Ricardo Uauy
ricardo.uauy@lshtm.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ricardo Uauy
ORCID ID
Contact details
London School of Hygiene and Tropical Medicine
NPHIRU/EPH
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7958 8126
ricardo.uauy@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
075219
Study information
Scientific title
Cost-Effectiveness of Nutritional supplementation and EXercise programme among older people in Santiago, Chile
Acronym
CENEX-Chile
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.
Ethics approval
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
Study design
Factorial cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/08/2005
Overall trial end date
01/11/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
2800
Participant 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)
Recruitment start date
01/08/2005
Recruitment end date
31/05/2006
Locations
Countries of recruitment
Chile
Trial participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
London School of Hygiene and Tropical Medicine (UK)
Sponsor details
Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7827 2678
penny.ireland@lshtm.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Funder name
Ministry of Health (Chile) (in kind contribution)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/17615064
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19473513
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21526229
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23636549
2013 secondary outcome analysis in: http://www.ncbi.nlm.nih.gov/pubmed/24016218
Publication citations
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Protocol
Dangour AD, Albala C, Aedo C, Elbourne D, Grundy E, Walker D, Uauy R, A factorial-design cluster randomised controlled trial investigating the cost-effectiveness of a nutrition supplement and an exercise programme on pneumonia incidence, walking capacity and body mass index in older people living in Santiago, Chile: the CENEX study protocol., Nutr J, 2007, 6, 14, doi: 10.1186/1475-2891-6-14.
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Protocol
Walker DG, Aedo C, Albala C, Allen E, Dangour AD, Elbourne D, Grundy E, Uauy R, Methods for economic evaluation of a factorial-design cluster randomised controlled trial of a nutrition supplement and an exercise programme among healthy older people living in Santiago, Chile: the CENEX study., BMC Health Serv Res, 2009, 9, 85, doi: 10.1186/1472-6963-9-85.
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Results
Dangour AD, Albala C, Allen E, Grundy E, Walker DG, Aedo C, Sanchez H, Fletcher O, Elbourne D, Uauy R, Effect of a nutrition supplement and physical activity program on pneumonia and walking capacity in Chilean older people: a factorial cluster randomized trial., PLoS Med., 2011, 8, 4, e1001023, doi: 10.1371/journal.pmed.1001023.
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Results
Garmendia ML, Dangour AD, Albala C, Eguiguren P, Allen E, Uauy R, Adherence to a physical activity intervention among older adults in a post-transitional middle income country: a quantitative and qualitative analysis., J Nutr Health Aging, 2013, 17, 5, 466-471, doi: 10.1007/s12603-012-0417-1.
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Secondary outcome analysis
Sanchez H, Albala C, Lera L, Dangour AD, Uauy R, Effectiveness of the National Program of Complementary Feeding for older adults in Chile on vitamin B12 status in older adults; secondary outcome analysis from the CENEX Study (ISRCTN48153354)., Nutr J, 2013, 12, 124, doi: 10.1186/1475-2891-12-124.