Clinical Trials Directory

Trials / Completed

CompletedNCT04999358

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Northumbria University · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALProtein educationThe 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.
BEHAVIORALStandard educationDietary 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.

Timeline

Start date
2021-11-29
Primary completion
2023-09-12
Completion
2023-09-12
First posted
2021-08-10
Last updated
2025-04-09

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04999358. Inclusion in this directory is not an endorsement.