Effectiveness of a Nurse-led Personalized Telephone Intervention on Lifestyle Changes in Diabetes Prevention.

University of the Balearic Islands206 enrolled

Overview

A randomized, 9-months, parallel-group study comparing the effectiveness of a nurse-led telephone personalized lifestyle intervention versus automated SMSs on nutritional and physical activity advice in the reduction of fasting blood glucose and/or HbA1c in a population with prediabetes.

It is estimated that about 70% of the prediabetic population will eventually develop type 2 diabetes (T2DM), contributing to the significant economic burden on health systems and societies. When prediabetes is recognized, lifestyle intervention including weight loss through diet and exercise can reduce the relative risk of developing T2DM by more than 50% within 3 years. In the context of the current pandemic caused by COVID-19 the implementation of prevention strategies is heavily affected. Telemedicine consultations give patients the opportunity to receive personalized advice on disease prevention even in times of pandemic. Previous studies on telemedicine intervention strategies for the prevention of T2DM show that there is a need to further explore the utility of telemedicine and especially telephone-based personalized behavioural interventions in patients with prediabetes.The aim of the present research is to determine whether a nurse-led personalized telephone lifestyle intervention is effective in reducing risk factors associated with the development of T2DM in subjects with prediabetes, versus automated short message service (SMS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

206

Conditions

Prediabetic State

Interventions

nurse-led teleconsultationBEHAVIORAL

Patients assigned to this group will receive personalized dietary and physical activity advice during 9 months. Behavioural goals and action plans will be developed in a stepwise manner in accordance with baseline levels of nutritional and physical activity adherence to recommendations.

SMSBEHAVIORAL

Patients assigned to this group will receive a total of 150 text messages (4 to 5 messages per week during weekdays) throughout the intervention period (9 months). The content of the text messages includes advice on diet and exercise.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Fasting plasma glucose between 100 and 125 mg/dL OR HbA1c between 5.7 and 6.4% * BMI ≥ 27 and \< 40 kg/m2 * Written informed consent Exclusion Criteria: * Documented history of T2DM or use of oral antidiabetic medication * Terminal illness * Institutionalization, dementia or cognitive impairment * Pregnancy * Major surgery or hospital stay during the previous 3 months * Documented history of hematologic disease which may interfere with the HbA1c measurement * Presence of any medical or psychological condition that may limit the ability of the patient to participate in the study * Concomitant active participation in another clinical trial

Locations (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, Spain

Outcomes

Primary Outcomes

Change in fasting plasma glucose

Change in fasting plasma glucose at 4, 9, and 15 months versus baseline

Time frame: at baseline, 4, 9, and 15 months

Secondary Outcomes

Blood levels of HbA1c

Change in HbA1c levels at 4, 9, and 15 months versus baseline

Time frame: at baseline, 4, 9, and 15 months

Maintenance of acquired dietary and physical activity changes

Whether lifestyle changes acquired during the 9-month active-intervention phase are maintained in the mid-term.

Time frame: 15 month

Data from ClinicalTrials.gov

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