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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: Lifestyle changes (diet and physical activity)

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Miquel Bennasar Veny, PhD; Phone Number: +34 971172367; Email: miquel.bennasar@uib.es
• Study Contact Backup: Name: Aina M Yanez Juan, PhD; Phone Number: +34 971172367; Email: aina.yanez@uib.es

Study Locations

• Spain
  • Balearic Islands
    • Palma De Mallorca, Balearic Islands, Spain, 07122
      • University of the Balearic Islands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants with prediabetes included in the intervention arm of the PREDIPHOE randomized controlled trial.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High adherence; Participants with high adherence to the lifestyle intervention	Behavioral: Lifestyle changes (diet and physical activity); Nurse-led telephone personalized dietary and PA advice
Low adherence; Participants with low adherence to the lifestyle intervention	Behavioral: Lifestyle changes (diet and physical activity); Nurse-led telephone personalized dietary and PA advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	at month 9 of the intervention period

Collaborators and Investigators

• Sponsor: University of the Balearic Islands

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Prediabetes; Healthy lifestyle; Social determinants of health; Therapeutic adherence and compliance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 2023/02723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No