Protein Intake in Patients With Coronary Heart Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; Coronary Heart Disease; Low Protein Intake
• Intervention / Treatment: Behavioral: Protein education; Behavioral: Standard education

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alasdair O'Doherty, PhD; Email: alasdair.odoherty@northumbria.ac.uk
• Study Contact Backup: Name: Emily James; Phone Number: 07849425535; Email: ejcj1@leicester.ac.uk

Study Locations

• United Kingdom
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Newcastle Upon Tyne Hospitals NHS Trust
    • Contact: Linda Llewellyn; Email: linda.llewellyn1@nhs.net
    • Principal Investigator: Emily James
    • Sub-Investigator: Simon Nichols, PhD
    • Sub-Investigator: Stuart Goodall, PhD
    • Sub-Investigator: Alasdair O'Doherty, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein group; 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	Behavioral: Protein education; 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.
Placebo Comparator: Control group; 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.	Behavioral: Standard education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
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.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
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.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
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.	Baseline, up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Change in waist circumference.	Between-group intervention effect for waist circumference will be assessed as a simple indicator of body composition.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
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.	24 hours.
Adherence	Adherence will be assessed as the amount of education sessions completed by participants, as a percentage of those prescribed.	Up to 12 weeks.
Attrition.	Attrition will be assessed as the percentage of participants that drop out of the intervention before the study period is complete.	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Occurrence of adverse events	Adverse events (such as injury or illness) that are directly related to the intervention will be reported..	Up to 12 weeks and up to 24 weeks; time points determined by CR standard duration.
Understanding and evaluation of the intervention.	A short questionnaire will determine patients' understanding of the educational material and their evaluation of the intervention	Baseline and up to 12 weeks.

Collaborators and Investigators

• Sponsor: Northumbria University
• Collaborators: Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Study Chair: Alasdair O'Doherty, PhD, University of Northumbria at Newcastle

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Coronary heart disease; Telehealth; Protein
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Sarcopenia
• Other Study ID Numbers: 296288

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