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

Not yet recruiting

• Conditions: PreDiabetes

• Registration Number: NCT06488677
• Lead Sponsor: University of the Balearic Islands

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study Start: 2024-06-30
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Facilitators and barriers to adherence to lifestyle changes	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
Adherence to healthy lifestyle recommendations	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.

Trial Locations

Locations (1)

University of the Balearic Islands; 🇪🇸 Palma De Mallorca, Balearic Islands, Spain