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

Study Overview
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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.

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).

Official Title
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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

Conditions
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Prediabetic State

Intervention / Treatment
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* Behavioral: nurse-led teleconsultation
* Behavioral: SMS


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-led teleconsultation group<br>9-month nurse-led telephone-based personalized behavioural intervention. | Behavioral: nurse-led teleconsultation<br>* 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.<br>|
| Active Comparator: SMS group<br>Behavioural intervention by means of short text messages. | Behavioral: SMS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of HbA1c | Change in HbA1c levels at 4, 9, and 15 months versus baseline | 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. | 15 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prediabetes, type 2 diabetes, fasting plasma glucose, diet, physical activity, randomized clinical trial