Condition category
Respiratory
Date applied
25/01/2005
Date assigned
22/07/2005
Last edited
23/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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

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.

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

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

Supplement

Phase

Not Applicable

Drug names

Micronutrient fortified nutritional supplements

Primary outcome measures

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 measures

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)

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 - recruitment ends on 31/05/2006

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

01/11/2007

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

http://www.lshtm.ac.uk

Funders

Funder type

Government

Funder name

The Wellcome Trust (UK) (grant ref: 075219)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes