Clinical trial NCT06488677: Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes
Official title: Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes: A Sequential Explanatory Mixed-Methods Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: PreDiabetes
Keywords: Healthy lifestyle
Social determinants of health
Prediabetes
Therapeutic adherence and compliance
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with prediabetes included in the intervention arm of the PREDIPHOE randomized controlled trial.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to healthy lifestyle recommendations
timeFrame: at month 9 of the intervention period
measure: Facilitators and barriers to adherence to lifestyle changes
timeFrame: at month 9 of the intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: University of the Balearic Islands
state: Balearic Islands
Study officials:
References: