Adherence to Nutritional Treatment Following MI Using Telemedicine Treatment (ADNUT)

Summary

Background and aim: Cardiovascular diseases (CVDs) are the leading cause of death and disability worldwide. Although cardiac rehabilitation (CR) is an effective modality that reduces the risk for death, hospital readmissions and improves the quality of life (QoL), only a third of the patients participate in CR. The association between individual nutrients and dietary patterns such as the Mediterranean diet (MedDiet) have been shown to reduce the risk of myocardial infarction (MI) and mortality. Every 1-point increase in Mediterranean diet score is associated with a 12% decrease in mortality. Although physical activity and nutrition counseling are core components of CR, less than a third of remote CR programs provide nutrition counseling. In the current study, we aim to compare the effectiveness of remote, web-based nutrition counseling (WBNC) to standard in-person nutrition counseling (IPNC).

Methods: Patients one month or less from hospital discharge for MI, who are capable of conducting a conversation using Zoom software, will be eligible to participate. In a single-blind, controlled single-center study, a 1: 1 randomization will be performed for web-based nutrition counseling (WBNC) intervention or standard in-person nutrition counseling (IPNC). Patients from both groups will receive the usual CR program (medical follow-up and on-site physical activity). Interventions will be delivered at baseline, 45 days, and 90 days post-baseline. Follow-up assessments will be performed at 6 months. Patients will complete questionnaires for socioeconomic information, physical activity level, motivation to perform lifestyle changes, food intake, adherence to MedDiet and QoL. Anthropometric measures and handgrip strength will be obtained. Medical information, lipid profile and fasting glucose level will be obtained from patient's records. Calculated sample size: 90 patients to reject the null hypothesis (no difference in between-group adherence to MedDiet) with 80% power and a confidence interval of 95%.

Expected results: The effectiveness of WBNC on adherence to MedDiet, anthropometric measures, and Qol. Our findings will enable us to identify target populations for whom nutritional treatment using telemedicine will achieve optimal results.

Importance to Medicine: Remote nutrition counseling has the potential to increase the accessibility and participation of patients, thus reducing gaps in medical service, hospitalizations, complications, and mortality. If proven beneficial, remote treatment will also allow for continuity of treatment during emergencies and closure.

Conditions

• Cardiovascular Diseases
• Acute MI

Interventions

BEHAVIORAL

Medical Nutrition Therapy (counselling)

Participants will receive nutrition counseling to enhance adherence to the principles of the Mediterranean diet and support the achievement of adequate levels of lipid control, blood pressure and weight.

Sponsors & Collaborators

• Sheba Medical Center

  collaborator OTHER_GOV

• Soroka University Medical Center

  collaborator OTHER

• Ariel University

  lead OTHER

Principal Investigators

• Robert Klempfner, MD, PhD · Sheba Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-21

Primary Completion

2024-08-25

Completion

2024-08-25

Countries

• Israel

Study Locations