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The Effect of Lifestyle Modification on the Risk of Prediabetes Among Patients Attending Outpatient Clinic.

NCT07462078 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-03-10

No results posted yet for this study

Summary

Diabetes mellitus is a major global health challenge, with type 2 diabetes (T2DM) accounting for nearly 90% of all cases worldwide. In Egypt, diabetes prevalence among adults is high (15.2%), with approximately 10.9 million people currently affected and projections estimating a rise to 13 million by 2030, placing Egypt among the top ten countries worldwide for diabetes prevalence. Alarmingly, a large proportion of diabetes and most prediabetes cases remain undiagnosed.

Prediabetes is a common, asymptomatic, and reversible condition that precedes T2DM and is characterized by elevated blood glucose levels not meeting diagnostic thresholds for diabetes. Diagnostic criteria include impaired fasting plasma glucose, impaired glucose tolerance, and elevated HbA1c. Globally, prediabetes affects nearly one-third of adults, and in Egypt its prevalence ranges from 21-24% in community and occupational settings. Individuals with prediabetes face a significantly increased risk of progressing to T2DM, cardiovascular disease, and mortality, with up to 70% developing diabetes during their lifetime if left untreated.

Early identification of prediabetes is essential and cost-effective. Non-invasive screening tools such as the Finnish Diabetes Risk Score (FINDRISC) provide a practical method for identifying high-risk individuals, who can then undergo confirmatory blood testing. Lifestyle modification is the cornerstone of prediabetes management and is more effective than pharmacological therapy alone. Evidence shows that modest weight loss, increased physical activity, and dietary improvements significantly reduce diabetes incidence and improve glycemic parameters.

Structured lifestyle programs, particularly the Diabetes Prevention Program (DPP), have demonstrated substantial benefits through achieving at least 7% weight loss and 150 minutes of moderate physical activity per week. Establishing nationwide screening and lifestyle intervention programs in Egypt is strongly recommended to reduce the burden of diabetes. Local implementation initiatives provide critical evidence to support the scalability and effectiveness of such preventive strategies.

Conditions

Interventions

BEHAVIORAL

Lifestyle modification

A combination of interactive counseling, visual educational materials, audio reminders and mobile-based support tools was used to enhance participants' understanding, motivation and adherence to lifestyle modification recommendations. Printed visual aids, illustrated dietary guides, anthropometric feedback charts and physical activity posters were used during counseling sessions. Audio messages and phone reminders were delivered to reinforce behavioral change and improve compliance throughout the intervention period.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2025-05-02
Completion
2025-06-02

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07462078 on ClinicalTrials.gov