Hip FracturesNCT06451679
Postoperative Dietary Intake of Hip Fracture Patients
An observational study of Hip Fractures and Malnutrition, run by Teesside University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures, Malnutrition, Comorbidities and Coexisting Conditions
- What is being tested?
- Observational
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective older adult hip fracture patients aged 60 and over at the point of admission.
Who may be able to join
- Adults >60yrs with a confirmed diagnosis of a hip fracture requiring surgical repair.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Teesside University
Middlesbrough, TS1 3BX
John Franklin, +441642218121, j.franklin@tees.ac.uk
Helen Lloyd
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Hip Fractures, Malnutrition, Comorbidities and Coexisting Conditions, Postoperative Complications
- Being tested
- Observational
- Keywords
- Hip fracture, Perioperative, Surgical, Food diary, Nutrition
- Medical subject headings
- Hip Fractures, Malnutrition, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational prospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative dietary energy intake (kJ/kcal) of older adult hip fracture patients meets Resting Energy Expenditure (REE) needs.
REE in kJ/kcal
Measured: 3 days
Secondary outcomes (4)
The Correlation between comorbidity (where reported) and postoperative dietary intake, according to dietary intake.
Correlation between comorbidity and dietary intake
Measured: 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.
Link between complications and dietary intake
Measured: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Postoperative dietary intake
Measured: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
The length of hospital stay.
Measured: From day of surgery until discharge from acute hospital stay, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start13 May 2024
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Lloyd, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451679
- Sponsor's protocol ID
- 2024 Jan 19539 LLOYD
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lloyd H, Allison S, Burn N, Zohoori FV, Jones C, Whittaker V, Franklin JD. Acute postoperative dietary intake in older adult hip fracture patients: An exploratory three-day weighed food diary observational study. Nutr Health. 2026 Oct 9:2601060261494308. doi: 10.1177/02601060261494308. Online ahead of print.
PubMed 42852989
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation Study of Postoperative Dietary Intake of Older Adult Hip Fracture Patients: a Weighed Food Diary
- ClinicalTrials.gov ID
- NCT06451679
- Acronym / sponsor ID
- 2024 Jan 19539 LLOYD
- Conditions
- Hip Fractures, Malnutrition, Comorbidities and Coexisting Conditions, Postoperative Complications
- Keywords
- Hip fracture, Perioperative, Surgical, Food diary, Nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective older adult hip fracture patients aged 60 and over at the point of admission.
Key inclusion criteria (1 listed)
- Adults >60yrs with a confirmed diagnosis of a hip fracture requiring surgical repair.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational prospective study | Other | – |
Primary outcome
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
4 secondary outcomes
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 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
Postoperative dietary intake
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 42852989Lloyd H, Allison S, Burn N, Zohoori FV, Jones C, Whittaker V, Franklin JD. Acute postoperative dietary intake in older adult hip fracture patients: An exploratory three-day weighed food diary observational study. Nutr Health. 2026 Oct 9:2601060261494308. doi: 10.1177/02601060261494308. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Malnutrition, run by Teesside University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative dietary energy intake (kJ/kcal) of older adult hip fracture patients meets Resting Energy Expenditure (REE) needs. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.