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Protein Intake in Patients With Coronary Heart Disease

Primary Purpose

Coronary Heart Disease, Low Protein Intake, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Protein education
Standard education
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Protein, Coronary heart disease, Rehabilitation, Telehealth

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 50 years or older.
  • Recent diagnosis of coronary heart disease or a cardiac event related to coronary heart disease.
  • Have been offered standard cardiac rehabilitation in a Newcastle upon Tyne Hospitals NHS Foundation Trust.
  • Usually receive dietary education as part of their cardiac rehabilitation program.
  • Able to understand and undertake the tasks described as part of this study.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Patients advised against participation in light exercise by a medical professional.
  • Patients younger than 50 years.
  • Patients unable to alter their diet due to medical reasons; including patients that have been prescribed artificial feeding, texture modified diets, and specialist renal diets.
  • Patients with known stage 4 or 5 chronic kidney disease.
  • Patients without access to teleconferencing technology or without another adult present (≥18 years; and with capacity to supervise the activity) will be excluded from participating in the remote sit-to-stand test for their safety.

Sites / Locations

  • Newcastle upon Tyne Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protein group

Control group

Arm Description

Participants in the protein group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the protein group will be provided with an additional targeted protein education session, which will aim to increase the amount of foods eaten with protein in them (≥1.2 g/kg protein/day) and improve the quality of protein sources that are eaten. The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD

Participants in the control group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the control group will receive an additional dietary education session that is similar to the standard practice sessions, containing only information that is usually provided in the cardiac rehabilitation programme.The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD.

Outcomes

Primary Outcome Measures

Change in protein intake (g/kg/day).
Between-group intervention effect for dietary protein intake in the intervention and control groups. Protein intake is assessed with a three-day food diary.

Secondary Outcome Measures

Prevalence of low protein intake in patients with coronary heart disease.
Average protein intake and percentage of participants with protein intake <1.2 g/kg/day and <0.8 g/kg/day.
Change in sit to stand performance (leg strength).
Between-group intervention effect for sit to stand performance in the intervention and control groups. The time taken to complete five consecutive sit to stands will be recorded.
Change in sarcopenia risk score and self-reported physical activity.
Between-group intervention effect for questionnaire scores in the intervention and control groups. Sarcopenia risk and physical activity are assessed using the modified SARC-F questionnaire (SARC-F+EBM; includes age and body mass index) and Physical Activity Vital Signs questionnaire (PAVS), respectively.
Difference in protein intake between patients with and without probable sarcopenia.
Probable sarcopenia is assessed using sit to stand time. The cut-off point for probable sarcopenia will be >15seconds to complete five sit to stands, as proposed by the European Working Group on Sarcopenia in Older People-2.
Change in waist circumference.
Between-group intervention effect for waist circumference will be assessed as a simple indicator of body composition.
Reliability of self-assessed waist circumference.
Whilst COVID-19 restrictions are in place, participants will be required to complete their own waist circumference measurement. Measures will be taken 24 hours apart to determine their reliability.
Adherence
Adherence will be assessed as the amount of education sessions completed by participants, as a percentage of those prescribed.
Attrition.
Attrition will be assessed as the percentage of participants that drop out of the intervention before the study period is complete.
Occurrence of adverse events
Adverse events (such as injury or illness) that are directly related to the intervention will be reported..
Understanding and evaluation of the intervention.
A short questionnaire will determine patients' understanding of the educational material and their evaluation of the intervention

Full Information

First Posted
July 29, 2021
Last Updated
September 1, 2022
Sponsor
Northumbria University
Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04999358
Brief Title
Protein Intake in Patients With Coronary Heart Disease
Official Title
The Effectiveness of a Targeted Protein Education Telehealth Intervention to Increase Protein Intake in Patients With Coronary Heart Disease and Low Protein Intake: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University
Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. Sarcopenia affects around 1 in 10 older adults in the general population. However, in patients with coronary heart disease (CHD), this number is almost 3 in 10. Patients who have CHD are offered cardiac rehabilitation (CR); a multicomponent programme designed to improve long-term health outcomes. Nutritional education is an important part of CR and typically focuses around modifying fat and carbohydrate intake to lower cholesterol levels and achieve a healthy weight. Currently there is little focus on increasing protein intake, which might reduce the risk of sarcopenia. Eligible patients with CHD and low protein intake will receive the standard nutritional education delivered during CR. Next, participants will be randomised to one of two groups: protein education (intervention), or standard information (control). Whilst COVID-19 restrictions are in place, education will be delivered remotely via pre-recorded video. Outcome measures, including protein intake, sit to stand performance, sarcopenia risk score (modified SARC-F), Physical Activity Vital Signs (PAVS) and waist circumference, will be assessed at baseline, at the end of the standard CR programme and after a follow-up period of the same duration as the CR programme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Low Protein Intake, Sarcopenia
Keywords
Protein, Coronary heart disease, Rehabilitation, Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a single centre, parallel-group, two arm, randomised controlled trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protein group
Arm Type
Experimental
Arm Description
Participants in the protein group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the protein group will be provided with an additional targeted protein education session, which will aim to increase the amount of foods eaten with protein in them (≥1.2 g/kg protein/day) and improve the quality of protein sources that are eaten. The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Participants in the control group will receive their usual education session(s) as part of standard practice cardiac rehabilitation. The session(s) will be the same for both study arms and will align with the dietary education sessions that these patients would usually be given during their normal cardiac rehabilitation programme. Participants in the control group will receive an additional dietary education session that is similar to the standard practice sessions, containing only information that is usually provided in the cardiac rehabilitation programme.The content and materials for these sessions can be provided in-person or are available as pre-recorded videos, accessed by participants via the internet or DVD.
Intervention Type
Behavioral
Intervention Name(s)
Protein education
Intervention Description
The protein education session is pre-recorded and will describe in lay terms: the health issues associated with low protein intake, the amount of protein to eat in a day, and provide useful information to increase protein intake. This information will focus on the quality and amount of protein eaten, primarily using a whole-food approach. For example, the education sessions will give ideas for everyday foods that can be added to regular meals, favouring plant proteins, fish, lean meat, poultry, low fat dairy and eggs. The education session has been provided in conjunction with an NHS dietitian.
Intervention Type
Behavioral
Intervention Name(s)
Standard education
Intervention Description
Dietary advice provided as part of standard cardiac rehabilitation will be pre-recorded and provided to the control group. This education session will be in addition to usual care.
Primary Outcome Measure Information:
Title
Change in protein intake (g/kg/day).
Description
Between-group intervention effect for dietary protein intake in the intervention and control groups. Protein intake is assessed with a three-day food diary.
Time Frame
Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Secondary Outcome Measure Information:
Title
Prevalence of low protein intake in patients with coronary heart disease.
Description
Average protein intake and percentage of participants with protein intake <1.2 g/kg/day and <0.8 g/kg/day.
Time Frame
Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Title
Change in sit to stand performance (leg strength).
Description
Between-group intervention effect for sit to stand performance in the intervention and control groups. The time taken to complete five consecutive sit to stands will be recorded.
Time Frame
Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Title
Change in sarcopenia risk score and self-reported physical activity.
Description
Between-group intervention effect for questionnaire scores in the intervention and control groups. Sarcopenia risk and physical activity are assessed using the modified SARC-F questionnaire (SARC-F+EBM; includes age and body mass index) and Physical Activity Vital Signs questionnaire (PAVS), respectively.
Time Frame
Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Title
Difference in protein intake between patients with and without probable sarcopenia.
Description
Probable sarcopenia is assessed using sit to stand time. The cut-off point for probable sarcopenia will be >15seconds to complete five sit to stands, as proposed by the European Working Group on Sarcopenia in Older People-2.
Time Frame
Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Title
Change in waist circumference.
Description
Between-group intervention effect for waist circumference will be assessed as a simple indicator of body composition.
Time Frame
Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Title
Reliability of self-assessed waist circumference.
Description
Whilst COVID-19 restrictions are in place, participants will be required to complete their own waist circumference measurement. Measures will be taken 24 hours apart to determine their reliability.
Time Frame
24 hours.
Title
Adherence
Description
Adherence will be assessed as the amount of education sessions completed by participants, as a percentage of those prescribed.
Time Frame
Up to 12 weeks.
Title
Attrition.
Description
Attrition will be assessed as the percentage of participants that drop out of the intervention before the study period is complete.
Time Frame
Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Title
Occurrence of adverse events
Description
Adverse events (such as injury or illness) that are directly related to the intervention will be reported..
Time Frame
Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Title
Understanding and evaluation of the intervention.
Description
A short questionnaire will determine patients' understanding of the educational material and their evaluation of the intervention
Time Frame
Baseline and up to 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 50 years or older. Recent diagnosis of coronary heart disease or a cardiac event related to coronary heart disease. Have been offered standard cardiac rehabilitation in a Newcastle upon Tyne Hospitals NHS Foundation Trust. Usually receive dietary education as part of their cardiac rehabilitation program. Able to understand and undertake the tasks described as part of this study. Able to provide written informed consent. Exclusion Criteria: Patients advised against participation in light exercise by a medical professional. Patients younger than 50 years. Patients unable to alter their diet due to medical reasons; including patients that have been prescribed artificial feeding, texture modified diets, and specialist renal diets. Patients with known stage 4 or 5 chronic kidney disease. Patients without access to teleconferencing technology or without another adult present (≥18 years; and with capacity to supervise the activity) will be excluded from participating in the remote sit-to-stand test for their safety.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily James
Phone
01912437018
Email
emily.j.c.james@northumbria.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alasdair O'Doherty, PhD
Email
alasdair.odoherty@northumbria.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alasdair O'Doherty, PhD
Organizational Affiliation
University of Northumbria at Newcastle
Official's Role
Study Chair
Facility Information:
Facility Name
Newcastle upon Tyne Hospitals NHS Trust
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Llewellyn
Email
linda.llewellyn1@nhs.net
First Name & Middle Initial & Last Name & Degree
Emily James
First Name & Middle Initial & Last Name & Degree
Simon Nichols, PhD
First Name & Middle Initial & Last Name & Degree
Stuart Goodall, PhD
First Name & Middle Initial & Last Name & Degree
Alasdair O'Doherty, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Protein Intake in Patients With Coronary Heart Disease

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