University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122, Spain
NCT Number: NCT04735640
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.
Looking for future studies?
Notify Me20 year–75 year
All sexes
Interventional
Not applicable
Palma de Mallorca, Balearic Islands, 07122, Spain
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: at baseline, 4, 9, and 15 months
Change in fasting plasma glucose at 4, 9, and 15 months versus baseline
Time frame: at baseline, 4, 9, and 15 months
Change in HbA1c levels at 4, 9, and 15 months versus baseline
Time frame: 15 month
Whether lifestyle changes acquired during the 9-month active-intervention phase are maintained in the mid-term.
University of the Balearic Islands
Other
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
Acronym: PREDIPHONE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06471569
Behavior, Body Weight
Durham, North Carolina, United States
View Trial DetailsNCT05056376
Behavior, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT04984421
Body Weight, Child Nutrition Disorders
Huddinge, Stockholm County, Sweden
View Trial DetailsNCT05694351
Behavior, Diabetes Mellitus
Slagelse, Denmark
View Trial Details