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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prediabetic State
- Sponsor
- University of the Balearic Islands
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Change in fasting plasma glucose
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
Josep1
PhD
University of the Balearic Islands
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in fasting plasma glucose
Time Frame: at baseline, 4, 9, and 15 months
Change in fasting plasma glucose at 4, 9, and 15 months versus baseline
Secondary Outcomes
- Blood levels of HbA1c(at baseline, 4, 9, and 15 months)
- Maintenance of acquired dietary and physical activity changes(15 month)