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

Not Applicable

Completed

• Conditions: Prediabetic State
• Interventions: Behavioral: nurse-led teleconsultation; Behavioral: SMS

• Registration Number: NCT04735640
• Lead Sponsor: University of the Balearic Islands

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-04-13
• Primary Completion: 2023-09-27
• Study Completion: 2023-12-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse-led teleconsultation group	nurse-led teleconsultation	9-month nurse-led telephone-based personalized behavioural intervention.
SMS group	SMS	Behavioural intervention by means of short text messages.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood levels of HbA1c	at baseline, 4, 9, and 15 months	Change in HbA1c levels at 4, 9, and 15 months versus baseline
Maintenance of acquired dietary and physical activity changes	15 month	Whether lifestyle changes acquired during the 9-month active-intervention phase are maintained in the mid-term.

Trial Locations

Locations (1)

University of the Balearic Islands; 🇪🇸 Palma De Mallorca, Balearic Islands, Spain