Randomized Controlled Trial Intervention With New Nordic DIet in Women With GestatiOnal Diabetes Mellitus: iNDIGO

NCT04169243 | Terminated

• 1 other identifier: iNDIGO2018-00483
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

The study evaluates whether the New Nordic Diet, compared to routine care, will improve glucose control, among women developing gestational diabetes mellitus during pregnancy. Originally, a 10 wk intervention with qualified counseling on New Nordic Diet was planned, and effects on glycosylated haemoglobin A (HbA1c) at gestational age 37 weeks was planned as main outcome. Recruitment started in spring 2020 but had to be halted due to covid-19. Instead, we now conduct a more comprehensive version of the study, with a more intensive intervention consisting of distributed food bags plus dietary counselling for two weeks, and with continuous glucose monitoring during these two weeks to measure main outcome. This is more sensitive to small changes than is HbA1c. With this shorter and more intensive intervention we believe we can address our original hypothesis yet adjust to impacts of the covid-19 situation on the population and health care system.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Time in Target at gestational week 32

  Percentage of time in target (TIT) range 3.5-7.8 mmol/L measured with continuous glucose monitoring

  At week 32 of pregnancy

Secondary Outcomes (15)

• Pregnancy weight gain

  Pre-pregnant weight up to delivery

• Incidence of pregnancy-induced hypertension

  Up to delivery

• Incidence of pre-eclampsia

  Up to delivery

• Prevalence of use of insulin/Metformin treatment

  Up to delivery

• Incidence of preterm delivery

  Up to 37 completed weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Women randomized to the New Nordic Diet meet the study dietician at week 30 for 1.5 hr of individual diet treatment according to the New Nordic Diet and a cognitive behavioral approach. The diet advice include evenly distributed meals over the day, foods low in fat and rich in fibre, 500 g fruit and vegetables daily, fish 2-3 times a week and keyhole foods. Participants will prepare their own food but are provided with recipes and food bags containing ingredients and foods to be consumed during the two-week intervention At gestational age 32 weeks, women meet with a dietitian and will be instructed to continue with the New Nordic Diet diet throughout pregnancy on their own.

Behavioral: New Nordic Diet

Control

ACTIVE COMPARATOR

The control women receive diet advice according to usual care.

Other: Control

Interventions

New Nordic Diet BEHAVIORAL

The New Nordic Diet conforms with the Nordic Nutrition Recommendations and incorporates environmental sustainability and planetary health. It includes rapeseed oil, whole grain bread, wild fish, seafood and game, potatoes, root vegetables, cabbages, Nordic fruits and berries. A two-week menu including all daily meals has been created to ensure dietary goals of the New Nordic Diet intervention: fish and shellfish intake ≥ 3 times/w (fatty fish at least once per week), ≥ 500 g fruit, berries, vegetables and legumes daily (legumes as main protein source at least twice per week), whole-grain cereal products, rapeseed oil for cooking/dressing and three table spoons of nuts and seeds per day.

Intervention

Control OTHER

The control women receive diet advice according to usual care, which may be a short meeting with the regular midwife or a short meeting with a dietician. From the study, they will receive a gift certificate that can be used in grocery stores.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women with diagnosis of gestational diabetes in pregnancy wks 24-28.

You may not qualify if:

• multiple pregnancies
• not understanding/able to read Swedish or English
• unwilling to follow a dietary intervention
• manifest diabetes

Sponsors & Collaborators

• Göteborg University: lead
• Swedish Council for Working Life and Social Research: collaborator

Study Sites (3)

Antenatal care

Gothenburg, S-41650, Sweden

Location

Region Stockholm

Stockholm, Sweden

Location

Region Västerbotten

Umeå, 90185, Sweden

Location

Related Publications (1)

• Karlsson T, Augustin H, Lindqvist M, Otten J, Petersson K, Storck-Lindholm E, Mogren I, Winkvist A. Effect of the New Nordic Diet compared with usual care on glucose control in gestational diabetes mellitus: Study protocol for the randomized controlled trial intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO). Contemp Clin Trials. 2022 Apr;115:106706. doi: 10.1016/j.cct.2022.106706. Epub 2022 Feb 12.

  PMID: 35158086 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Officials

• Anna Winkvist, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome is percentage of time in target of blood glucose values, measured with continuous glucose monitoring. The device will be masked for participants. Still, because the trial is a diet intervention, participants will know their group status. However, initial data reaching the Investigators will not have the code broken.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 19, 2019
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)