PreDiabetesNCT06488677
Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes
An observational study of PreDiabetes, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
A sequential explanatory mixed-methods study analyzing the influence of social determinants on adherence to healthy lifestyle recommendations in individuals with prediabetes. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Lifestyle changes (diet and physical activity)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2024to 30 Dec 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants with prediabetes included in the intervention arm of the PREDIPHOE randomized controlled trial.
Who may be able to join
- participants of the PREDIPHONE trial assigned to the intervention group and who complete the 9-month intervention period
Who cannot join
- Participants from the control group or those who withdrew from the 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: Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes: A Sequential Explanatory Mixed-Methods Study
A sequential explanatory mixed-methods study analyzing the influence of social determinants on adherence to healthy lifestyle recommendations in individuals with prediabetes.
Read the detailed description
Type 2 diabetes (T2D) is a major risk factor for adult morbidity and mortality and represents a public health burden due to its rising global prevalence. T2D is preceded by prediabetes, a phase characterized by higher-than-normal blood glucose levels that do not reach the threshold required for a T2D diagnosis. It is estimated that 70% of people with prediabetes will eventually develop T2D, with a mean annual incidence rate ranging from 5% to 10%.
Importantly, socioeconomic status exacerbates the risk of developing chronic diseases such as T2D, as people from underprivileged social classes are significantly more susceptible to the development of the disease and its complications, when compared to the more privileged.
In fact, it has been observed that the risk of developing T2D extends beyond physiological factors. Social determinants (SD) such as age, gender, ethnicity, postal code, or socioeconomic status, and health beliefs are strong predictors of disease onset and progression. Populations with a low socioeconomic status (i.e., economically disadvantaged backgrounds, lower health literacy levels, lower educational status, and often, from ethnic and racial minorities), are known to experience reduced access to healthcare including health promotion programs. They also have lower adoption rates of health behaviors, such as physical activity (PA) and healthy diet, and thus be at increased risk of chronic diseases such as T2D, which finally increases their likelihood to suffer inequalities in mortality.
For all of the above, this study aims to explore the influence of SD on adherence behaviors in individuals with prediabetes included in the PREDIPHONE trial, using a mixed-methods sequential explanatory design. The findings from both the quantitative and qualitative phases will be integrated to offer a comprehensive understanding of the complex phenomenon of adherence.
- Conditions
- PreDiabetes
- Being tested
- Lifestyle changes (diet and physical activity)
- Keywords
- Healthy lifestyle, Social determinants of health, Prediabetes, Therapeutic adherence and compliance
- Medical subject headings
- Prediabetic State, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle changes (diet and physical activity)Behavioural
Nurse-led telephone personalized dietary and PA advice
| Study group | Role | What they receive |
|---|---|---|
| High adherence | Participants with high adherence to the lifestyle intervention Receives: Behavioral: Lifestyle changes (diet and physical activity) | |
| Low adherence | Participants with low adherence to the lifestyle intervention Receives: Behavioral: Lifestyle changes (diet and physical activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to healthy lifestyle recommendations
Adherence to healthy lifestyle recommendations measured through a composite index generated with data from 1) dietary adherence assessed using the 14-item PREDIMED Mediterranean Diet questionnaire and 2) physical activity adherence evaluated using the REGICOR Abbreviated Questionnaire.
Measured: at month 9 of the intervention period
Facilitators and barriers to adherence to lifestyle changes
Facilitators and barriers to adherence to lifestyle changes such as social and family support, knowledge about one's health condition, health beliefs, and the patient-professional relationship
Measured: at month 9 of the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488677
- Sponsor's protocol ID
- 2023/02723
- Other IDs
- 2023
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvalho-Azevedo AS, Sebastian-Hernandez R, Abbate M, Fresneda S, Arias-Fernandez M, Yanez AM, Bennasar-Veny M, Moreno-Mulet C. Understanding barriers and facilitators of adherence to lifestyle changes in prediabetes: a qualitative study. Int J Qual Stud Health Well-being. 2026 Dec 31;21(1):2643664. doi: 10.1080/17482631.2026.2643664. Epub 2026 Mar 12.
PubMed 41817101Carvalho-Azevedo A, Abbate M, Fresneda S, Arias-Fernandez M, Torres-Carballo M, Yanez AM, Moreno-Mulet C, Bennasar-Veny M. Influence of social determinants on lifestyle modification adherence in people with prediabetes: a sequential explanatory mixed-methods study protocol. Front Public Health. 2025 Jul 3;13:1591205. doi: 10.3389/fpubh.2025.1591205. eCollection 2025.
PubMed 40678653
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes: A Sequential Explanatory Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT06488677
- Acronym / sponsor ID
- 2023/02723
- Conditions
- PreDiabetes
- Keywords
- Healthy lifestyle, Social determinants of health, Prediabetes, Therapeutic adherence and compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Jul 2024 (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 sequential explanatory mixed-methods study analyzing the influence of social determinants on adherence to healthy lifestyle recommendations in individuals with prediabetes.
Detailed description
Type 2 diabetes (T2D) is a major risk factor for adult morbidity and mortality and represents a public health burden due to its rising global prevalence. T2D is preceded by prediabetes, a phase characterized by higher-than-normal blood glucose levels that do not reach the threshold required for a T2D diagnosis. It is estimated that 70% of people with prediabetes will eventually develop T2D, with a mean annual incidence rate ranging from 5% to 10%.
Importantly, socioeconomic status exacerbates the risk of developing chronic diseases such as T2D, as people from underprivileged social classes are significantly more susceptible to the development of the disease and its complications, when compared to the more privileged.
In fact, it has been observed that the risk of developing T2D extends beyond physiological factors. Social determinants (SD) such as age, gender, ethnicity, postal code, or socioeconomic status, and health beliefs are strong predictors of disease onset and progression. Populations with a low socioeconomic status (i.e., economically disadvantaged backgrounds, lower health literacy levels, lower educational status, and often, from ethnic and racial minorities), are known to experience reduced access to healthcare including health promotion programs. They also have lower adoption rates of health behaviors, such as physical activity (PA) and healthy diet, and thus be at increased risk of chronic diseases such as T2D, which finally increases their likelihood to suffer inequalities in mortality.
For all of the above, this study aims to explore the influence of SD on adherence behaviors in individuals with prediabetes included in the PREDIPHONE trial, using a mixed-methods sequential explanatory design. The findings from both the quantitative and qualitative phases will be integrated to offer a comprehensive understanding of the complex phenomenon of adherence.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High adherence | – | Behavioral: Lifestyle changes (diet and physical activity)Participants with high adherence to the lifestyle intervention |
| Low adherence | – | Behavioral: Lifestyle changes (diet and physical activity)Participants with low adherence to the lifestyle intervention |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with prediabetes included in the intervention arm of the PREDIPHOE randomized controlled trial.
Key inclusion criteria (1 listed)
- participants of the PREDIPHONE trial assigned to the intervention group and who complete the 9-month intervention period
Key exclusion criteria (1 listed)
- Participants from the control group or those who withdrew from the trial.
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 |
|---|---|---|
| Lifestyle changes (diet and physical activity)Nurse-led telephone personalized dietary and PA advice | Behavioural | High adherence, Low adherence |
Primary outcome
Adherence to healthy lifestyle recommendations
Time frame: at month 9 of the intervention period
Adherence to healthy lifestyle recommendations measured through a composite index generated with data from 1) dietary adherence assessed using the 14-item PREDIMED Mediterranean Diet questionnaire and 2) physical activity adherence evaluated using the REGICOR Abbreviated Questionnaire.
Facilitators and barriers to adherence to lifestyle changes
Time frame: at month 9 of the intervention period
Facilitators and barriers to adherence to lifestyle changes such as social and family support, knowledge about one's health condition, health beliefs, and the patient-professional relationship
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Derived from this study: PubMed 41817101Carvalho-Azevedo AS, Sebastian-Hernandez R, Abbate M, Fresneda S, Arias-Fernandez M, Yanez AM, Bennasar-Veny M, Moreno-Mulet C. Understanding barriers and facilitators of adherence to lifestyle changes in prediabetes: a qualitative study. Int J Qual Stud Health Well-being. 2026 Dec 31;21(1):2643664. doi: 10.1080/17482631.2026.2643664. Epub 2026 Mar 12.
- Derived from this study: PubMed 40678653Carvalho-Azevedo A, Abbate M, Fresneda S, Arias-Fernandez M, Torres-Carballo M, Yanez AM, Moreno-Mulet C, Bennasar-Veny M. Influence of social determinants on lifestyle modification adherence in people with prediabetes: a sequential explanatory mixed-methods study protocol. Front Public Health. 2025 Jul 3;13:1591205. doi: 10.3389/fpubh.2025.1591205. eCollection 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miquel Bennasar Veny, PhD (+34 971172367, miquel.bennasar@uib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to healthy lifestyle recommendations (time frame: at month 9 of the intervention period). The study lists 2 primary outcomes in all. 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 NCT06488677, which also lists 2 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 5 Jul 2024.