Nutrition Counseling, Diet Quality, and Advanced Glycation End Products in Gestational Diabetes

Sponsor
Istanbul Saglik Bilimleri University
Study ID
NCT07636577
Status
Not Yet Recruiting

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Conditions

  • Gestational Diabetes Mellitus
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Structured Nutrition Counseling — BEHAVIORAL
    A dietitian-led structured nutrition counseling, education, and follow-up program provided in addition to standard care. The program includes education on pregnancy, gestational diabetes mellitus, adequate and balanced nutrition, appropriate gestational weight gain, portion control, low glycemic index food choices, reduction of highly processed foods, healthy cooking methods, carbohydrate intake, and meal planning. Follow-up will be conducted at least every two weeks by telephone, online, or face-to-face sessions. Dietary records and weight changes will be reviewed, and individualized feedback and motivational support will be provided.
  • Standard Care — OTHER
    Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.

Study Details

This study will evaluate the relationship between structured nutrition counseling, diet quality, and advanced glycation end products in pregnant women with gestational diabetes mellitus and women with normal glucose tolerance. Participants will be assigned to either a structured nutrition counseling group or a standard care group according to glucose tolerance status. The counseling program will include education and follow-up on healthy eating during pregnancy, gestational diabetes management, portion control, food choices, meal planning, and cooking methods. Diet quality, dietary habits, biochemical parameters, advanced glycation end products, gestational weight gain, and fetal outcomes will be assessed during follow-up.

Key Dates

First listed
Jun 9, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: NGT-Control
    Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.
  • Experimental: NGT-Intervention
    Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling.
  • Active Comparator: GDM-Control
    Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation.
  • Experimental: GDM-Intervention
    Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling.

Primary Outcome Measure

Diet Quality Score [ Time Frame: Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation ]

Central Contacts

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