Cost-effectiveness of nutritional supplementation and exercise programme among older people in Santiago, Chile

ISRCTN	ISRCTN48153354
DOI	https://doi.org/10.1186/ISRCTN48153354
Protocol serial number	075219
Sponsor	London School of Hygiene and Tropical Medicine (UK)
Funders	Wellcome Trust, Ministry of Health (Chile) (in kind contribution)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Ricardo Uauy
Scientific

London School of Hygiene and Tropical Medicine
NPHIRU/EPH
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7958 8126
Email	ricardo.uauy@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Factorial cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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)
Completion date	01/11/2007

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

United Kingdom
England
Chile

Study participating centre

London School of Hygiene and Tropical Medicine

London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2011		Yes	No
Results article	results	01/04/2013		Yes	No
Results article	results	24/07/2017		Yes	No
Protocol article	protocol	05/07/2007		Yes	No
Protocol article	protocol	27/05/2009		Yes	No
Other publications	secondary outcome analysis	09/09/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/07/2017: Publication reference added.
04/02/2016: Plain English summary added.