NCT04735640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2023

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

January 29, 2021

Last Update Submit

July 5, 2024

Conditions

Prediabetic State

Keywords

prediabetestype 2 diabetesfasting plasma glucosedietphysical activityrandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Change in fasting plasma glucose

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

    at baseline, 4, 9, and 15 months

Secondary Outcomes (2)

  • Blood levels of HbA1c

    at baseline, 4, 9, and 15 months

  • Maintenance of acquired dietary and physical activity changes

    15 month

Study Arms (2)

Nurse-led teleconsultation group

EXPERIMENTAL

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

Behavioral: nurse-led teleconsultation

SMS group

ACTIVE COMPARATOR

Behavioural intervention by means of short text messages.

Behavioral: SMS

Interventions

nurse-led teleconsultationBEHAVIORAL

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.

Nurse-led teleconsultation group
SMSBEHAVIORAL

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.

SMS group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Related Publications (2)

  • Arias-Fernandez M, Huguet-Torres A, Abbate M, Fresneda S, Torres-Carballo M, Carvalho-Azevedo A, Yanez AM, Bennasar-Veny M. Effectiveness of a low-intensity nurse-led lifestyle intervention on glycaemic control in individuals with prediabetes: The PREDIPHONE randomized controlled clinical trial. Int J Nurs Stud. 2025 May;165:105034. doi: 10.1016/j.ijnurstu.2025.105034. Epub 2025 Feb 22.

    PMID: 40058011DERIVED

  • 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.

    PMID: 33769603DERIVED

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Miquel Bennasar Veny, PhD

    University of the Balearic Islands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

April 13, 2021

Primary Completion

September 27, 2023

Study Completion

December 19, 2023

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)