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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-led teleconsultation group | Experimental | 9-month nurse-led telephone-based personalized behavioural intervention. |
|
| SMS group | Active Comparator | Behavioural intervention by means of short text messages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nurse-led teleconsultation | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miquel Bennasar Veny, PhD | University of the Balearic Islands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of the Balearic Islands | Palma de Mallorca | Balearic Islands | 07122 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40058011 | Derived | Arias-Fernandez M, Huguet-Torres A, Abbate M, Fresneda S, Torres-Carballo M, Carvalho-Azevedo A, Yanez AM, Bennasar-Veny M. Effectiveness of a low-intensity nurse-led lifestyle intervention on glycaemic control in individuals with prediabetes: The PREDIPHONE randomized controlled clinical trial. Int J Nurs Stud. 2025 May;165:105034. doi: 10.1016/j.ijnurstu.2025.105034. Epub 2025 Feb 22. | |
| 33769603 |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| SMS | 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. |
|
| 15 month |
| Derived |
| Abbate M, Fresneda S, Yanez A, Ricci-Cabello I, Galmes-Panades AM, Aguilo A, Bennasar-Veny M; PREDIPHONE trial group. Nurse-led telephone intervention for lifestyle changes on glycaemic control in people with prediabetes: Study protocol for a randomized controlled trial. J Adv Nurs. 2021 Jul;77(7):3204-3217. doi: 10.1111/jan.14842. Epub 2021 Mar 26. |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |