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Completed

NCT Number: NCT03131856

Nutritional Intervention in Geriatric Patients

This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 65 or above
  • BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill

Exclusion criteria

  • Terminal illness
  • Active cancer diagnosis
  • Permanently living in a nursing home
  • Not willing or able to give an informed consent.

Treatment and study plan

Nutritional intervention programme

Behavioral

The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.

Primary outcomes

  1. Nutritional status

    Time frame: Three months follow-up

    Change in body weight (kg)

Secondary outcomes

  1. Functional status

    Time frame: Three months follow-up

    Barthel Index (scale 0-100)

  2. Functional status

    Time frame: Three months follow-up

    Handgrip strength (kg)

  3. Self-rated health

    Time frame: Three months follow-up

    Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health?

  4. Re-admission

    Time frame: Up to three months

    All-cause unplanned readmissions

  5. Mortality

    Time frame: 1) Up to 90 days after discharge 2) Up to 120 days after discharge

    All-cause mortality

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 27, 2017
Registry last updated
Apr 27, 2017

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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