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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2023-12-19

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Prediabetic State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nurse-led teleconsultation group

9-month nurse-led telephone-based personalized behavioural intervention.

Group Type EXPERIMENTAL

nurse-led teleconsultation

Intervention Type BEHAVIORAL

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 group

Behavioural intervention by means of short text messages.

Group Type ACTIVE_COMPARATOR

SMS

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes