Prediabetic StatePREDIPHONENCT04735640
Effectiveness of a Nurse-led Personalized Telephone Intervention on Lifestyle Changes in Diabetes Prevention.
A study testing nurse-led teleconsultation and SMS in people with Prediabetic State, run by University of the Balearic Islands at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State
- What is being tested?
- nurse-led teleconsultation and SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2021to 19 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of the Balearic Islands
Palma de Mallorca, Balearic Islands, 07122
About this study
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
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.
Read the 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).
- Conditions
- Prediabetic State
- Being tested
- nurse-led teleconsultation, SMS
- Keywords
- prediabetes, type 2 diabetes, fasting plasma glucose, diet, physical activity, randomized clinical trial
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-led teleconsultationBehavioural
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.
SMSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led teleconsultation group | Experimental | 9-month nurse-led telephone-based personalized behavioural intervention. Receives: Behavioral: nurse-led teleconsultation |
| SMS group | Active comparator | Behavioural intervention by means of short text messages. Receives: Behavioral: SMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting plasma glucose
Change in fasting plasma glucose at 4, 9, and 15 months versus baseline
Measured: at baseline, 4, 9, and 15 months
Secondary outcomes (2)
Blood levels of HbA1c
Change in HbA1c levels at 4, 9, and 15 months versus baseline
Measured: at baseline, 4, 9, and 15 months
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.
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start13 Apr 2021
- Primary completion27 Sep 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Josep1, University of the Balearic Islands
- Investigators
- Miquel Bennasar Veny, PhD, Principal investigator, University of the Balearic Islands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735640
- Sponsor's protocol ID
- PI18/01209
- Acronym
- PREDIPHONE
- Status last verified
- Jul 2024
- First submitted
- 29 Jan 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Coll N, Arias-Fernandez M, Abbate M, Torres-Carballo M, Huguet-Torres A, Zamanillo-Campos R, Ricci-Cabello I, Bennasar-Veny M, Yanez AM, Galmes-Panades AM. Effectiveness of a nurse-led phone intervention on body composition in adults with prediabetes and overweight/obesity: PREDIPHONE secondary analysis. Front Endocrinol (Lausanne). 2026 Sep 17;17:1911675. doi: 10.3389/fendo.2026.1911675. eCollection 2026.
PubMed 42824031Arias-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.
PubMed 40058011Abbate 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.
PubMed 33769603
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04735640
- Acronym / sponsor ID
- PREDIPHONE / PI18/01209
- Conditions
- Prediabetic State
- Keywords
- prediabetes, type 2 diabetes, fasting plasma glucose, diet, physical activity, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led teleconsultation group | Experimental | Behavioral: nurse-led teleconsultation9-month nurse-led telephone-based personalized behavioural intervention. |
| SMS group | Active comparator | Behavioral: SMSBehavioural intervention by means of short text messages. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-led teleconsultationPatients 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. | Behavioural | Nurse-led teleconsultation group |
| SMSPatients 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. | Behavioural | SMS group |
Primary outcome
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
2 secondary outcomes
Blood levels of HbA1c
Time frame: at baseline, 4, 9, and 15 months
Maintenance of acquired dietary and physical activity changes
Time frame: 15 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 42824031Garcia-Coll N, Arias-Fernandez M, Abbate M, Torres-Carballo M, Huguet-Torres A, Zamanillo-Campos R, Ricci-Cabello I, Bennasar-Veny M, Yanez AM, Galmes-Panades AM. Effectiveness of a nurse-led phone intervention on body composition in adults with prediabetes and overweight/obesity: PREDIPHONE secondary analysis. Front Endocrinol (Lausanne). 2026 Sep 17;17:1911675. doi: 10.3389/fendo.2026.1911675. eCollection 2026.
- Derived from this study: PubMed 40058011Arias-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.
- Derived from this study: PubMed 33769603Abbate 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miquel Bennasar Veny, PhD principal investigator
University of the Balearic Islands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led teleconsultation and SMS in people with Prediabetic State, run by University of the Balearic Islands at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting plasma glucose (time frame: at baseline, 4, 9, and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735640, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.