Healthy Eating in Women at Risk of Gestational Diabetes

NCT05299502 | Active Not Recruiting DMC

• 1 other identifier: 2022-6100
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy eating during pregnancy has favorable effects on markers related to diabetes (glucose tolerance) and is associated with lower gestational diabetes mellitus (GDM) risk. The cornerstone of GDM treatment is nutrition therapy but the latter often starts late in pregnancy and thus may not have the expected effects on glucose tolerance. What if an intervention promoting healthy eating was initiated at the beginning of pregnancy in all women at risk, would it improve glucose homeostasis? To answer this important question, the investigators will perform a randomized controlled trial in 150 pregnant women. Women receiving the nutritional intervention will be compared to a control group receiving standard care. The nutritional intervention, which will start in the first trimester, is based on the 2019 Canada's Food Guide and is composed of 4 individual sessions with a registered dietitian (12, 18, 24 and 30 weeks). Between those follow-ups, informative nutritional web capsules and phone calls with the registered dietitian will be provided. To ensure that the women remain motivated and receive social support, a private Facebook group will be used. The investigators hypothesize that the nutritional intervention will be effective at improving glucose homeostasis. The investigators expect the results will show the importance of nutritional care starting early in pregnancy in women at risk of GDM.

Conditions

Gestational Diabetes; Pregnancy Complications

Keywords

Nutrition; Healthy Eating; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Fasting plasma glucose

  Measured after a 12-hour fast.

  Changes from the 1st to the 3rd trimester

Secondary Outcomes (6)

• Post-prandial plasma glucose

  Changes from the 1st to the 3rd trimester

• Glycemic response

  Changes from the 1st to the 3rd trimester

• Hepatic insulin sensitivity

  Changes from the 1st to the 3rd trimester

• Hepatic and peripheral insulin sensitivity index

  Changes from the 1st to the 3rd trimester

• Beta-cell function index

  Changes from the 1st to the 3rd trimester

Study Arms (2)

Nutritional Intervention

EXPERIMENTAL

Intervention promoting healthy eating by a Registered Dietitian.

Behavioral: Nutritional Intervention

Standard Care

NO INTERVENTION

Women will have their usual medical pregnancy follow-ups by their MDs without access to nutritional care.

Interventions

Nutritional Intervention BEHAVIORAL

4 individual 1-hour in person (or virtual, according to potential public health restrictions and patients' preference) motivational interviews (12, 18, 24 and 30 weeks) with a registered dietitian will be conducted to elaborate S.M.A.R.T. (Specific,Measurable, Attainable, Relevant, Timely) goals regarding diet, based on the 2019 Canada's Food Guide. Between those individual follow-ups, 4 phone calls with the registered dietitian will be provided (15, 21, 27, 33 weeks). Throughout the study, 10 informative nutritional video clips will also be provided. Participants receiving the intervention will have access to an online Facebook private community to discuss and share experiences, thus maintaining motivation and providing social support.

Nutritional Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 14 gestational weeks;
• Singleton pregnancy;
• At risk of GDM According to Diabetes Canada (being 35 years of age or older or from a high-risk group (African, Arab, Asian, Hispanic, Indigenous, or South Asian) or having a BMI ≥ 30 kg/m2, prediabetes, GDM in a previous pregnancy, given birth to a baby that weighed more than 4 kg, a parent, brother or sister with type 2 diabetes, polycystic ovary syndrome or acanthosis nigricans (darkened patches of skin).

You may not qualify if:

• Having a diabetes diagnosis in the 1st trimester;
• Pre-existing diabetes mellitus;
• Diseases requiring active nutritional treatment or influencing glucose metabolism (including previous bariatric surgery);
• Taking part in a nutritional intervention program;
• Corticosteroid use;
• Previous or current diagnosis of an eating disorder;
• Inability to give informed consent;
• Inability to communicate in French.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Laval University: collaborator

Study Sites (1)

CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

• Bernier E, Plante AS, Lemieux P, Robitaille J, Lemieux S, Desroches S, Belanger-Gravel A, Maheux-Lacroix S, Weisnagel SJ, Demers S, Camirand Lemyre F, Boulet M, Baillargeon JP, Morisset AS. Promoting healthy eating in early pregnancy in individuals at risk of gestational diabetes mellitus: does it improve glucose homeostasis? A study protocol for a randomized control trial. Front Nutr. 2024 Jan 19;10:1336509. doi: 10.3389/fnut.2023.1336509. eCollection 2023.

  PMID: 38312142 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Anne-Sophie Morisset, RD, PhD

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 29, 2022
• Study Start: June 30, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)