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临床试验/NCT06488677
NCT06488677尚未招募不适用

Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes: A Sequential Explanatory Mixed-Methods Study

University of the Balearic Islands1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Facilitators and barriers to adherence to lifestyle changes

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Participants from the control group or those who withdrew from the trial.

结局指标

主要结局

Facilitators and barriers to adherence to lifestyle changes

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University of the Balearic Islands
申办方类型
Other
责任方
Sponsor

研究点 (1)

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