Effect of Intensive Nutrition Training, Education, and Support in Gestational Diabetes - The INTENSE-GDM TRIAL

NCT06127823 | Active Not Recruiting

• 1 other identifier: H-23055674
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of gestational diabetes (GDM) primarily revolves around consuming an optimal diet that does not cause blood glucose levels to become excessively high and provides an adequate supply of micro- and macronutrients without resulting in excessive weight gain during pregnancy. In some cases, it may become necessary to supplement with insulin during pregnancy. However, insulin treatment is associated with personal, health-related, and healthcare cost-related implications. The rationale for this study is the lack of knowledge regarding whether the extent of support and guidance from a dietitian during pregnancy has an impact on the treatment outcomes for both the mother and the child in cases of GDM. The overall objective is to investigate differences in clinical, cost-related, and patient-reported outcomes between women with GDM randomised to either intensive dietary therapy or standard dietary care (control). The primary endpoint is the effect of intensive dietary therapy on the likelihood of remaining treated with diet only vs. needing insulin therapy. The study design is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM.

Conditions

GDM; Gestational Diabetes; Nutritional and Metabolic Diseases; Nutrition Therapy; Medical Nutrition Therapy

Keywords

GDM; Nutrition care; Dietary management; Insulin use; Hospital costs

Outcome Measures

Primary Outcomes (1)

• Percentage of insulin-treated

  Percentage of women with GDM treated with insulin therapy in the two study groups

  From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks

Secondary Outcomes (9)

• Maternal body weight

  From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks

• Maternal glycaemic control

  From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks

• Onset of insulin treatment

  From date of randomisation until date of first insulin prescription, assessed from study completion up to 24 weeks

• Prescribed insulin

  From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks

• Large for gestational age (LGA)

  At delivery, assessed from study completion up to 24 weeks

Other Outcomes (21)

• Neonatal jaundice

  From date of randomisation until data of discharge after child delivery, assessed from study completion up to 24 weeks

• Planned caesarean sections

  From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks

• Acute caesarean sections

  From date of randomisation until date of child delivery, assessed from study completion up to 24 weeks

Study Arms (2)

Intensive dietary care group

EXPERIMENTAL

Women randomised to the intensive dietary intervention group will receive one initial dietary counselling consultation (60 min), and two mandatory follow-up consultations (2 x 30 min) with a dietitian. In addition, participants in this group will be offered 1-2 follow-up consultations (1-2 x 15-30 min) if needed.

Behavioral: Dietary treatment

Standard dietary care group

ACTIVE COMPARATOR

Women randomised to the standard dietary care group will receive one dietary counselling consultation (60 min) according to the initial dietary counselling described without any follow-up consultations with a dietitian. Participants are encouraged to follow their dietary plan until delivery.

Behavioral: Dietary treatment

Interventions

Dietary treatment BEHAVIORAL

Dietary counselling

Intensive dietary care group; Standard dietary care group

Eligibility Criteria

• Gender Eligibility Details: Only biological gender
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed women with GDM referred to Department of Obstetrics Herlev Hospital
• Women diagnosed with GDM based on 2-hour OGTT plasma glucose value ≥ 9.0 mmol/l
• Women diagnosed with GDM based on at least 2 plasma glucose measurements above targets (either pre-prandial ≥6.0 mmol/l, or 2-hours postprandial ≥8.0 mmol/l)
• GA at GDM diagnosis ≤ 34
• Women with an estimated probability of ≥20% for initiating insulin treatment during pregnancy. The estimated probability is based on a logistic regression model developed at SDCC and includes the following variables: prepregnancy BMI, GA at GDM diagnosis, and HbA1c at GDM diagnosis. In cases where HbA1c has not been measured during the initial visit with the dietitian (screening visit), prepregnancy BMI, GA at the time of diagnosis and 2H OGTT will be used to estimate the probability of initiating insulin therapy.
• Provided voluntary written informed parental consent in Danish or English or after translation by an interpreter for non-Danish and non-English speaking parents

You may not qualify if:

• Bariatric surgery
• Other intercurrent illness (e.g., cancer, ulcerative colitis) as judged by medical experts
• Uncontrolled medical issues, as judged by medical experts
• Concomitant participation in other clinical trials that could interfere with the INTENSE- GDM Trial as evaluated by the principle investigator
• Unable to understand the informed consent/procedures regardless of spoked language

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Herlev Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, DK-2730, Denmark

Location

Related Publications (1)

• Ewers B, Blond MB, Kelstrup L, Foghsgaard S, Bergholt T, Hansen MJ, Storgaard H, Holmager P, Mathiesen ER. Effect of intensive nutrition training, education and support versus standard therapy in reducing the need for insulin therapy in gestational diabetes (INTENSE-GDM): a protocol for a randomised controlled single-centre trial in Denmark. BMJ Open. 2025 Feb 17;15(2):e089231. doi: 10.1136/bmjopen-2024-089231.

  PMID: 39961720 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Nutritional and Metabolic Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bettina Ewers, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The randomisation list will be made by a researcher/statistician not involved in the trial, who will be the only person to access the randomisation list during the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nutrition

Model Details: The INTENSE-GDM trial is a randomised controlled parallel group open-label effectiveness trial. Participants will be randomised to either an intensive dietary counselling group or a usual dietary care group (control group) in a 1:1 ratio.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 13, 2023
• Study Start: January 3, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)