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OpenTrials
Completed

NCT Number: NCT04735640

Effectiveness of a Nurse-led Personalized Telephone Intervention on Lifestyle Changes in Diabetes Prevention.

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Blood levels of HbA1c

    Time frame: at baseline, 4, 9, and 15 months

    Change in HbA1c levels at 4, 9, and 15 months versus baseline

  2. Maintenance of acquired dietary and physical activity changes

    Time frame: 15 month

    Whether lifestyle changes acquired during the 9-month active-intervention phase are maintained in the mid-term.

Sponsors and collaborators

Lead sponsor

University of the Balearic Islands

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study 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

Acronym: PREDIPHONE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2021
Registry last updated
Jul 8, 2024

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.

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