Basic Carbohydrate Counting in Prediabetes

Sponsor
Hamide Sahin
Study ID
NCT07525622
Status
Recruiting
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Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carbohydrate Couinting-Based Nutrition Education — BEHAVIORAL
    Participants assigned to the intervention group will receive a structured nutrition education program based on carbohydrate counting principles. The program will be delivered by a physician and will cover carbohydrate identification, portion estimation, meal planning, and practical application in daily dietary habits. The aim of the intervention is to improve glycemic control by increasing nutritional knowledge and promoting behavioral changes. Outcome measures will be evaluated at baseline, 3 months, and 6 months.
  • Standard Care (No Structured Nutrition Education) — BEHAVIORAL
    Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education.

Study Details

Type 2 diabetes mellitus (T2DM) is a major global health problem with rapidly increasing prevalence. Prediabetes represents a high-risk state for developing T2DM and is often asymptomatic, delaying diagnosis and intervention. Early identification and effective lifestyle interventions are essential to prevent or delay the progression to diabetes. Primary care settings provide an important opportunity for screening and implementing preventive strategies. Lifestyle modification, including dietary changes and physical activity, is the cornerstone of diabetes prevention. Carbohydrate counting is a medical nutrition therapy widely used in diabetes management and has been shown to improve glycemic control. However, there is limited evidence regarding its effectiveness in individuals with prediabetes. This study aims to evaluate the effect of basic carbohydrate counting education on HbA1c levels in individuals with prediabetes in a primary care setting. This randomized controlled trial will be conducted in the Family Medicine outpatient clinic of Marmara University Hospital. Individuals aged 18 years and older with HbA1c levels between 5.7% and 6.4% will be included. Participants will be randomized into intervention and control groups in a 2:1 ratio. The control group will receive standard lifestyle recommendations, while the intervention group will receive additional structured basic carbohydrate counting education in three sessions. HbA1c levels will be measured at baseline,at third and at 6 months. Secondary outcomes include body weight, body mass index, waist circumference,lipid panel and carbohydarte counting knowledge scale The findings of this study are expected to contribute to the development of effective, scalable, and practical nutritional interventions for diabetes prevention in primary care

Key Dates

First listed
Apr 13, 2026
Start date
Apr 27, 2026
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Care (No Structured Nutrition Education)
    Participants in the control group will receive standard care without structured carbohydrate counting-based nutrition education.
  • Experimental: Carbohydrate Counting-Based Nutrition Education
    Participants receive structured nutrition education based on carbohydrate counting, including dietary counseling and follow-up during the study period.

Primary Outcome Measure

The change in HbA1c level [ Time Frame: from baseline to 6 months ]

Central Contacts

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