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

NCT07636577 | Not Yet Recruiting

• 1 other identifier: 25-49
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus; Pregnancy

Keywords

Advanced Glycation End Products; Diet Quality; Nutrition Counseling; Dietary Habits; Highly Processed Food Consumption

Outcome Measures

Primary Outcomes (2)

• Diet Quality Score

  Diet quality will be assessed using the Diet Quality Index-International based on three-day food records. The score ranges from 0 to 100, with higher scores indicating better diet quality.

  Baseline at 24-28 weeks of gestation and final assessment at 32-36 weeks of gestation

• Serum Advanced Glycation End Products Level

  Serum advanced glycation end products levels will be measured using serum samples obtained from residual blood collected during routine clinical tests. Levels will be evaluated in relation to glucose tolerance status, nutrition counseling, diet quality, and dietary behaviors.

  Final assessment at approximately 32-36 weeks of gestation

Secondary Outcomes (6)

• Highly Processed Food Consumption Score

  Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation

• Dietary Habits and Cooking Methods

  Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation

• Gestational Weight Gain

  Baseline at 24-28 weeks of gestation and after 8 weeks of follow-up at approximately 32-36 weeks of gestation

• Birth Weight

  At delivery

• Gestational Age at Birth

  At delivery

Study Arms (4)

NGT-Control

ACTIVE COMPARATOR

Pregnant women with normal glucose tolerance receiving standard obstetric care and routine dietitian consultation.

Other: Standard Care

NGT-Intervention

EXPERIMENTAL

Pregnant women with normal glucose tolerance receiving standard obstetric care plus structured nutrition counseling.

Behavioral: Structured Nutrition Counseling; Other: Standard Care

GDM-Control

ACTIVE COMPARATOR

Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management and routine dietitian consultation.

Other: Standard Care

GDM-Intervention

EXPERIMENTAL

Pregnant women with gestational diabetes mellitus receiving standard gestational diabetes management plus structured nutrition counseling.

Behavioral: Structured Nutrition Counseling; Other: Standard Care

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.

GDM-Intervention; NGT-Intervention

Standard Care OTHER

Standard obstetric care or standard gestational diabetes management, when applicable, with routine dietitian consultation.

GDM-Control; GDM-Intervention; NGT-Control; NGT-Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Eligibility is limited to pregnant women because the study focuses on gestational diabetes mellitus and pregnancy-related nutritional and metabolic outcomes.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women aged 18 to 35 years
• Singleton and first pregnancy
• Gestational age between 24 and 28 weeks at enrollment
• Diagnosis of gestational diabetes mellitus or normal glucose tolerance
• Not using insulin therapy
• Stopped smoking at least 3 months before enrollment and not using alcohol
• Willingness to participate in the study
• Ability to provide written informed consent

You may not qualify if:

• Current use of insulin therapy
• Active smoking
• Alcohol use
• Refusal or inability to provide written informed consent

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Related Publications (1)

• Sisay M, Edessa D, Ali T, Mekuria AN, Gebrie A. The relationship between advanced glycation end products and gestational diabetes: A systematic review and meta-analysis. PLoS One. 2020 Oct 21;15(10):e0240382. doi: 10.1371/journal.pone.0240382. eCollection 2020.

  PMID: 33085688 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Feeding Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

BEYZANUR ÇAMLIBEL, Dietitian / PhD Candidate

CONTACT

+90 541 656 78 19; beyzanur.cmlbl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The laboratory personnel performing biochemical analyses will be blinded to group allocation. Participants and the dietitian delivering the intervention will not be blinded due to the nature of the nutrition counseling intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian, PhD Candidate

Model Details: Participants will be allocated into four parallel groups according to glucose tolerance status and intervention allocation: NGT-C, normal glucose tolerance control group receiving standard obstetric care and routine dietitian consultation; NGT-I, normal glucose tolerance intervention group receiving standard care plus structured nutrition counseling; GDM-C, gestational diabetes mellitus control group receiving standard gestational diabetes management and routine dietitian consultation; and GDM-I, gestational diabetes mellitus intervention group receiving standard gestational diabetes management plus structured nutrition counseling.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share