Clinical trial NCT04735640: Effectiveness of a Nurse-led Personalized Telephone Intervention on Lifestyle Changes in Diabetes Prevention.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: prediabetes
type 2 diabetes
fasting plasma glucose
diet
physical activity
randomized clinical trial
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2021-02-03
Enrollment: 206
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in fasting plasma glucose
timeFrame: at baseline, 4, 9, and 15 months
Secondary outcomes:
measure: Blood levels of HbA1c
timeFrame: at baseline, 4, 9, and 15 months
measure: Maintenance of acquired dietary and physical activity changes
timeFrame: 15 month
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
Study officials:
affiliation: University of the Balearic Islands
name: Miquel Bennasar Veny, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.