The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older

Abstract

Background: Too-low body mass index (BMI), HbA1c% or cholesterol levels predicts poor survival. This study investigates whether e-mails about these low values, improve health of people older than 75 years.

Methods: LIMIT - an open label randomized trial - compares usual care to the addition of an e-mail which alerts the family physicians and nurses to low metabolic indexes of a specific patient and advises on nutritional and medical changes.

Participants: Clalit Health Services (CHS) patients in the Northern and Southern Districts, aged ≥75 years with any of the following inclusion criteria: a. Significant weight loss: BMI < 23 kg/m2 with BMI drop of ≥2 kg/m2 during previous two years and without dietitian counseling during previous year. b. Tight diabetic control: HbA1c% ≤ 6.5% and received anti-diabetic medicines during previous 2 months. c. Drug associated hypocholesterolemia: total cholesterol <160 mg/dL and received cholesterol-lowering medicines during previous 2 months. Excluded from criterion c, were patients diagnosed with either ischemic heart disease, transient ischemic attack or stroke. The primary outcome was death from any cause, within one year. In a population of 48,623 people over the age of 75 years, 8584 (17.7%) patients were identified with low metabolic indices and were randomized to intervention or control groups. E-mails were sent on November 2015 to physicians and nurses at 383 clinics.

Discussion: Low metabolic reserve is common in people in Israel's peripheral districts aged ≥75 years. LIMIT may show whether alerting primary care staff is beneficial.

Trial registration: ClinicalTrials.gov NCT02476578 . Registered on June 11, 2015.

Keywords: Aged; Aged, 80 and over; Cholesterol Deficiency (hypocholesterolemia); Diabetes mellitus; Dietetics; Electronic mail; Glycated Hemoglobin A; Iatrogenic disease; Randomized controlled trial; Weight loss.

Conflict of interest statement

Ethics approval and consent to participate

Study protocol (Version #3., 5.10.15) was approved in advance by the CHS data safety board and by the institutional review board of CHS community division, affiliated with Carmel hospital. No data monitoring committee was mandated. Since the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context, a waiver for the requirement to obtain a signed informed consent was given. This waiver was needed because the tested intervention is purely informational. These ethical considerations are also consistent with the public welfare code of federal regulations [29].

Consent for publication

Not applicable

Competing interests

BK, MV, NT, SE, YG, YP and JR completed a declaration of competing interests and declare that they have no competing interests in this research.

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