NCT05498844: ADNUT

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

Completed NA Last updated 28 August 2024

What this trial tests

NA trial testing Medical Nutrition Therapy (counselling) in Cardiovascular Diseases in 126 participants. Completed in 25 August 2024.

Timeline

21 August 2022

Primary endpoint
25 August 2024

25 August 2024

Quick facts

Lead sponsor	Ariel University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	21 August 2022
Primary completion	25 August 2024
Estimated completion	25 August 2024
Sites	1 location across Israel

Drugs / interventions tested

• Medical Nutrition Therapy (counselling)

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Acute MI — all drugs for Acute MI →

Sponsor

Ariel University

Who can join

Adults 25 to 75, any sex, with Cardiovascular Diseases or Acute MI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.