Prediabetic State
Conditions
Keywords
prediabetes, type 2 diabetes, fasting plasma glucose, diet, physical activity, randomized clinical trial
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).
Interventions
BEHAVIORALnurse-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.
BEHAVIORALSMS
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.
Sponsors
Instituto de Salud Carlos III
University of the Balearic Islands
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed