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

University of the Balearic Islands

Status

Completed

Conditions

Prediabetic State

Treatments

Behavioral: SMS

Behavioral: nurse-led teleconsultation

Study type

Interventional

Funder types

Other

Identifiers

NCT04735640

PI18/01209

Details and patient eligibility

About

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.

Full description

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).

Enrollment

206 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

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