Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes

NCT ID: NCT06488677

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2024-12-30

Brief Summary

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A sequential explanatory mixed-methods study analyzing the influence of social determinants on adherence to healthy lifestyle recommendations in individuals with prediabetes.

Detailed Description

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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

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PreDiabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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High adherence

Participants with high adherence to the lifestyle intervention

Lifestyle changes (diet and physical activity)

Intervention Type BEHAVIORAL

Nurse-led telephone personalized dietary and PA advice

Low adherence

Participants with low adherence to the lifestyle intervention

Lifestyle changes (diet and physical activity)

Intervention Type BEHAVIORAL

Nurse-led telephone personalized dietary and PA advice

Interventions

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Lifestyle changes (diet and physical activity)

Nurse-led telephone personalized dietary and PA advice

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* participants of the PREDIPHONE trial assigned to the intervention group and who complete the 9-month intervention period

Exclusion Criteria

* Participants from the control group or those who withdrew from the trial.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Balearic Islands

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of the Balearic Islands

Palma de Mallorca, Balearic Islands, Spain

Site Status

Countries

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Spain

Central Contacts

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Miquel Bennasar Veny, PhD

Role: CONTACT

+34 971172367

Aina M Yanez Juan, PhD

Role: CONTACT

+34 971172367

References

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Carvalho-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.

Reference Type DERIVED
PMID: 40678653 (View on PubMed)

Other Identifiers

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2023/02723

Identifier Type: -

Identifier Source: org_study_id

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