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

NCT06488677 | Not Yet Recruiting

• 1 other identifier: 2023/02723
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PreDiabetes

Keywords

Healthy lifestyle; Social determinants of health; Prediabetes; Therapeutic adherence and compliance

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

High adherence

Participants with high adherence to the lifestyle intervention

Behavioral: Lifestyle changes (diet and physical activity)

Low adherence

Participants with low adherence to the lifestyle intervention

Behavioral: Lifestyle changes (diet and physical activity)

Interventions

Lifestyle changes (diet and physical activity) BEHAVIORAL

Nurse-led telephone personalized dietary and PA advice

High adherence; Low adherence

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of the Balearic Islands: lead

Study Sites (1)

University of the Balearic Islands

Palma de Mallorca, Balearic Islands, 07122, Spain

Location

Related Publications (1)

• 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.

  PMID: 40678653 DERIVED

MeSH Terms

Conditions

Prediabetic State; Treatment Adherence and Compliance

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Miquel Bennasar Veny, PhD

CONTACT

+34 971172367; miquel.bennasar@uib.es

Aina M Yanez Juan, PhD

CONTACT

+34 971172367; aina.yanez@uib.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 5, 2024
• Study Start: June 30, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)