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

Primary Purpose

Prediabetic State

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
nurse-led teleconsultation
SMS
Sponsored by
University of the Balearic Islands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetic State focused on measuring prediabetes, type 2 diabetes, fasting plasma glucose, diet, physical activity, randomized clinical trial

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of the Balearic Islands

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse-led teleconsultation group

SMS group

Arm Description

9-month nurse-led telephone-based personalized behavioural intervention.

Behavioural intervention by means of short text messages.

Outcomes

Primary Outcome Measures

Change in fasting plasma glucose
Change in fasting plasma glucose at 4, 9, and 15 months versus baseline

Secondary Outcome Measures

Blood levels of HbA1c
Change in HbA1c levels at 4, 9, and 15 months versus baseline
Maintenance of acquired dietary and physical activity changes
Whether lifestyle changes acquired during the 9-month active-intervention phase are maintained in the mid-term.

Full Information

First Posted
January 29, 2021
Last Updated
October 25, 2022
Sponsor
University of the Balearic Islands
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT04735640
Brief Title
Effectiveness of a Nurse-led Personalized Telephone Intervention on Lifestyle Changes in Diabetes Prevention.
Acronym
PREDIPHONE
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Balearic Islands
Collaborators
Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
prediabetes, type 2 diabetes, fasting plasma glucose, diet, physical activity, randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse-led teleconsultation group
Arm Type
Experimental
Arm Description
9-month nurse-led telephone-based personalized behavioural intervention.
Arm Title
SMS group
Arm Type
Active Comparator
Arm Description
Behavioural intervention by means of short text messages.
Intervention Type
Behavioral
Intervention Name(s)
nurse-led teleconsultation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMS
Intervention Description
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 Outcome Measure Information:
Title
Change in fasting plasma glucose
Description
Change in fasting plasma glucose at 4, 9, and 15 months versus baseline
Time Frame
at baseline, 4, 9, and 15 months
Secondary Outcome Measure Information:
Title
Blood levels of HbA1c
Description
Change in HbA1c levels at 4, 9, and 15 months versus baseline
Time Frame
at baseline, 4, 9, and 15 months
Title
Maintenance of acquired dietary and physical activity changes
Description
Whether lifestyle changes acquired during the 9-month active-intervention phase are maintained in the mid-term.
Time Frame
15 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miquel Bennasar Veny, PhD
Organizational Affiliation
University of the Balearic Islands
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Balearic Islands
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07122
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33769603
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.
Results Reference
derived

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

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