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

Prediabetic State Clinical Trial

— PREDIPHONE  

Official title:

Effects of a 9-months Nurse-led Telephone Personalized Lifestyle Intervention Versus Automated SMSs on Nutritional and Physical Activity Advice on Glucose Profile in Patients With Prediabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04735640
• Other study ID #: PI18/01209
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: October 2022
• Source: University of the Balearic Islands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: October 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Behavioral:
• nurse-led teleconsultation
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.
• SMS
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.

Locations

Country	Name	City	State
Spain	University of the Balearic Islands	Palma De Mallorca	Balearic Islands

Sponsors (2)

Lead Sponsor	Collaborator
University of the Balearic Islands	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting plasma glucose	Change in fasting plasma glucose at 4, 9, and 15 months versus baseline	at baseline, 4, 9, and 15 months
Secondary	Blood levels of HbA1c	Change in HbA1c levels at 4, 9, and 15 months versus baseline	at baseline, 4, 9, and 15 months
Secondary	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.	15 month