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Completed

NCT Number: NCT00479843

Nutritional Programme for Dementia Elderly Patient

The main objective of this study is the improvement of the quality of life and state of health of elderly people with cognitive deterioration and their families through a weight loss prevention programme.

The secondary objectives are the improvement of the state of nutrition, a reduction in the use of resources and a reduction in the burden on the main carer.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Body Weight Body Weight Changes Brain Diseases Central Nervous System Diseases Dementia Malnutrition Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies Weight Loss

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Català de l'envelliment

Barcelona, 08041, Spain

About this study

Main objective The main objective of this project is the evaluation of the effectiveness of a nutrition programme in patients with Alzheimer's or other dementias. Through the Nutrition Programme the idea is to reduce functional and weight loss in elderly people with cognitive deterioration and their families.

Evaluation of the effectiveness of the intervention

-The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

Secondary objectives

The secondary objectives of this study are:

  • Improvement in the patient's state of nutrition The measurement criteria which will allow the patient's nutritional state to be evaluated will be their weight, BMI and MNA.
  • Reducing the burden on carers. The Zarit scale will be used for this evaluation.
  • Evaluation of the use of healthcare and social resources. The RUD scale will be used.
  • Improvement of medical practice regarding nutrition.
  • Evaluation of the representatives of our population with regard to the participation in a programme of these characteristics evaluating.
  • Evaluation of the satisfaction of elderly people and their families in relation to the programme.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient has dementia according to DSM IV criteria.
  • The patient has an MMSE less than or equal to 26.
  • The patient lives in his/her home.
  • The patient is in the charge of a carer.
  • Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian.

Exclusion criteria

  • The patient lives in an institution.
  • The patient is in a terminal situation.
  • The patient does not have a main carer.
  • Patient has a nasogastric feed.

Treatment and study plan

Nutritional programme

Behavioral

Primary outcomes

  1. Evaluation of the effectiveness of the intervention -The main evaluation criteria which will allow the effectiveness of this intervention to be evaluated are the reduction in the loss of autonomy measured by the DA/IDA scale.

    Time frame: Baseline, 6 months, 12 months

Secondary outcomes

  1. -Improvement in the patient's state of nutrition -Reducing the burden on carers with the Zarit scale. -Evaluation of the use of healthcare and social resources with the RUD scale. -Improvement of medical practice regarding nutrition.

    Time frame: Baseline, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Group MAPI-NAXIS, CRO, Lyon, France
  • Hospital Purpan
  • Institut Català de l'envelliment, Barcelona, Spain
  • NESTEC R&D, Switzerland

Registry information

Official study title

Development of a Programme to Show the Positive Effect of a Nutritional Programme on Preventing Functional and Weight Losses in Patients With Dementia

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 28, 2007
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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