Postoperative Dietary Intake of Hip Fracture Patients

June 24, 2024 updated by: Helen Lloyd, Teesside University

An Observation Study of Postoperative Dietary Intake of Older Adult Hip Fracture Patients: a Weighed Food Diary

The goal of this observational study is to observe the postoperative dietary intake in older adult hip fracture patients from their day of surgery (day zero) until day three inclusive. The aims of this study are:

Primary aim:

To observe if the postoperative dietary energy intake (kJ/kcal) of older adult hip fracture patients meets Resting Energy Expenditure (REE) needs.

Secondary aims:

To explore if there is a correlation between postoperative dietary intake and length of hospital stay.

To explore the relationship between comorbidity (where reported) and postoperative dietary intake, according to dietary intake.

To explore (if) in the development of postoperative complications (infection, pressure ulcer and VTE), there is a correlation with postoperative dietary intake.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A hip fracture is one of the most serious injuries that an older adult can sustain and with the current projections from the NHS Long Term Workforce plan of an increase in >85yrs by 55% and a current estimation of over 75,000 hip fractures per year in England, Northern Ireland and Wales with a 6-8% mortality rate at 1 year, this warrants further research to improve outcomes and look at methods beyond the National Hip Fracture Database (NHFD) to ascertain what more can be done to optimise and improve this patient group. Whilst ONS supplementation is used on an ad-hoc basis for patients with a high-risk malnutrition screening score of 2 using the MUST screening method, such tools can lack sensitivity and accuracy and are also not developed to identify the development of malnutrition in-hospital.

The proposed study for this protocol is an observation study of the dietary intake of older adult hip fracture patients. The study will comprise of a weighed food diary, commencing on day zero after surgery. Potential participants that will be invited will be older adult hip fracture patients (>60yrs) with a confirmed hip fracture diagnosis that requires surgical repair. The diary will consist of the researcher weighing the plate of food before and after the participant's meal as this is regarded as a more accurate measure than relying on participant recall and does not place the participant under any additional stress.

The researcher will not handle any food, and plates will be placed on a digital scale. Should a food have a specified weight - for example a yoghurt, the weight on the product will be recorded. Fluid intake will be recorded according to drinks served with meals and jugs of water per day. After each meal the researcher will weigh the plate; if it is a multiple item meal (for example meat, potatoes, and vegetables), the researcher will weigh the leftover components individually to ensure the validity of the weighed food method and to achieve the highest degree of accuracy possible. The researcher will not be present nor disrupt the participant during their meal. After their meal, the researcher will ask the participant if they have had any additional snacks and observe if they have had any assistance with their meal. Data will also be obtained regarding the times of meals, the ratio of staff to patients and if any complications have developed.

The aim of this study is to explore the postoperative dietary intake of older adult hip fracture patients until day three after surgery. This builds on research where data on hip fracture patients was taken in relation to diet, anthropometry, and biochemical indices during inpatient stays. Whilst the study was commenced in the second week post-surgery and compared against values at the week 1 admission as a baseline, the researchers observed a longer length of stay, drops in energy intake that coincided with a low BMI on admission and additionally, referrals for high-risk patients that were not actioned.

Subsequent studies have used varied interventions to explore postoperative nutrition, however a weighed food diary has yet to be used in the immediate postoperative period, which justifies the need for this study to explore nutritional intake as accurately as possible.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Middlesbrough, United Kingdom, TS1 3BX
        • Recruiting
        • Teesside University
        • Contact:
        • Principal Investigator:
          • Helen Lloyd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Prospective older adult hip fracture patients aged 60 and over at the point of admission.

Description

Inclusion Criteria:

  • Adults >60yrs with a confirmed diagnosis of a hip fracture requiring surgical repair.

Exclusion Criteria:

  • Pathological hip fractures
  • Traumatic hip fractures - such as a road traffic collision injury.
  • Patients that cannot speak English due to the need for informed consent.
  • Patients undergoing oncologic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative dietary energy intake (kJ/kcal) of older adult hip fracture patients meets Resting Energy Expenditure (REE) needs.
Time Frame: 3 days
REE in kJ/kcal
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Correlation between comorbidity (where reported) and postoperative dietary intake, according to dietary intake.
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Correlation between comorbidity and dietary intake
From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Correlation between Postoperative complications (infection, pressure ulcer and VTE), and postoperative dietary intake.
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Link between complications and dietary intake
From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Postoperative dietary intake
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
From day of surgery until discharge from acute hospital stay, assessed up to 3 months
The length of hospital stay.
Time Frame: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
From day of surgery until discharge from acute hospital stay, assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024 Jan 19539 LLOYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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