Gestational Diabetes MellitusiNDIGONCT04169243
Randomized Controlled Trial Intervention With New Nordic DIet in Women With GestatiOnal Diabetes Mellitus: iNDIGO
A study testing New Nordic Diet in people with Gestational Diabetes Mellitus, run by Göteborg University at 3 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- New Nordic Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women with diagnosis of gestational diabetes in pregnancy wks 24-28.
Who cannot join
- multiple pregnancies
- not understanding/able to read Swedish or English
- unwilling to follow a dietary intervention
- manifest diabetes
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Antenatal care
Gothenburg, S-41650
Region Stockholm
Stockholm
Region Västerbotten
Umeå, 90185
About this study
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.
Read the detailed description
Gestational diabetes mellitus (GDM) is associated with severe adverse outcomes for mother and newborn. Recently introduced Swedish guidelines on GDM diagnosis will at least double the prevalence of diagnosed women. The first line of treatment in GDM is diet and exercise treatment. Even so, there is a recognized knowledge gap as to what diet treatment is optimal. In routine care today, diagnosed women are provided by midwife with the same diet advice as patients with diabetes type 2 and these are broad and general. Only rarely are the diet advice provided by a dietician. In nutrition research, most evidence for health benefits of a diet has been demonstrated for the Mediterranean diet. Further, the New Nordic Diet (NND) was recently developed to mimic the Mediterranean diet yet builds on foods grown in the Nordic climate, thus focusing on gastronomical potential and sustainability. Interestingly, a diet intake in line with NND among Norwegian mothers was associated with lower risk for excessive pregnancy weight gain. In addition, associations have been shown between NND and lower risk for cardiovascular disease, obesity, inflammatory risk markers, serum lipids, colorectal cancer and total mortality. Hence, it seems likely that diet treatment with NND to women with GDM would be superior to routine care, but this has never been investigated. The main aim of the randomized controlled trial Intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO) is to test if the NND compared with usual care will improve glucose control in women with GDM. The iNDIGO study is a randomized parallel, single-blinded, controlled trial. In total, 50 women diagnosed with GDM are recruited and randomized to receive either a NND (intervention) or usual care (control) for 14 days. Participants receive a two-week menu and provided with food bags containing ingredients for dishes and foods to be used. Primary outcome is glycemic control (specifically time in target) measured using continuous glucose monitoring. Compliance to the dietary intervention will be tested using known dietary biomarkers and adherence questionnaires. Maternal socio-demographic and clinical data, biological samples, dietary intake and physical activity will be collected at enrollment and at the end of intervention (30-32 weeks' gestation).
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- New Nordic Diet, Control
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Nordic DietBehavioural
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: New Nordic Diet |
| Control | Active comparator | The control women receive diet advice according to usual care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At week 32 of pregnancy
Secondary outcomes (15)
Pregnancy weight gain
Weight gain during pregnancy from self-reported pre-pregnancy weight until delivery
Measured: Pre-pregnant weight up to delivery
Incidence of pregnancy-induced hypertension
Diagnosis of pregnancy-induced hypertension
Measured: Up to delivery
Incidence of pre-eclampsia
Diagnosis of pre-eclampsia
Measured: Up to delivery
Prevalence of use of insulin/Metformin treatment
Decision to put woman on medication for the gestational diabetes, such as metformin or insulin
Measured: Up to delivery
Incidence of preterm delivery
Delivery before 37 completed weeks
Measured: Up to 37 completed weeks
Incidence of Caesarean sections
Delivery by caesarean sections
Measured: Up to delivery
Health-related quality of life
Health-related quality of life, calculated from questionnaire information from RAND-36
Measured: Up to 1 year postpartum
Incidence of LGA
Large-for-gestational age born infant
Measured: At delivery
Incidence of shoulder displacement
Shoulder displacement of newborn infant
Measured: At delivery
Apgar scores measurements
Apgar scores measured at 1, 5 and 10 minutes after delivery
Measured: At delivery
Additional measurements from continuous glucose monitoring at wk 32
mean glucose, CV, SD, MAGE, % time with values >7.8 mmol/L, % time with values <3.5 mmol/L, glucose in different time periods, and AUC
Measured: At gestational week 32
Additional measurements from continuous glucose monitoring at wk 36
mean glucose, CV, SD, MAGE, % time with values >7.8 mmol/L, % time with values <3.5 mmol/L, glucose in different time periods, and AUC
Measured: At gestational week 36
Incidence of macrosomia
Diagnosis of macrosomia in newborn infant
Measured: At delivery
Nutritional status
Nutritional status (vitamins and minerals) of mother during pregnancy
Measured: During pregnancy
Diet quality measuremen¨t
Diet intake quality of mother during pregnancy
Measured: Up to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Post-pandemic women did not engage in unnecessary tasks. Changes were made (more languages and sites, short proof-of-concept study, easier recepies, food for whole family, social media, etc. After 4 yr 5 women were recruited and trial terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Responsible party
- Sponsor
- Investigators
- Anna Winkvist, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169243
- Sponsor's protocol ID
- iNDIGO2018-00483
- Acronym
- iNDIGO
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2019
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35158086
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Intervention With New Nordic DIet in Women With GestatiOnal Diabetes Mellitus: iNDIGO
- ClinicalTrials.gov ID
- NCT04169243
- Acronym / sponsor ID
- iNDIGO / iNDIGO2018-00483
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Post-pandemic women did not engage in unnecessary tasks. Changes were made (more languages and sites, short proof-of-concept study, easier recepies, food for whole family, social media, etc. After 4 yr 5 women were recruited and trial terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gestational diabetes mellitus (GDM) is associated with severe adverse outcomes for mother and newborn. Recently introduced Swedish guidelines on GDM diagnosis will at least double the prevalence of diagnosed women. The first line of treatment in GDM is diet and exercise treatment. Even so, there is a recognized knowledge gap as to what diet treatment is optimal. In routine care today, diagnosed women are provided by midwife with the same diet advice as patients with diabetes type 2 and these are broad and general. Only rarely are the diet advice provided by a dietician. In nutrition research, most evidence for health benefits of a diet has been demonstrated for the Mediterranean diet. Further, the New Nordic Diet (NND) was recently developed to mimic the Mediterranean diet yet builds on foods grown in the Nordic climate, thus focusing on gastronomical potential and sustainability. Interestingly, a diet intake in line with NND among Norwegian mothers was associated with lower risk for excessive pregnancy weight gain. In addition, associations have been shown between NND and lower risk for cardiovascular disease, obesity, inflammatory risk markers, serum lipids, colorectal cancer and total mortality. Hence, it seems likely that diet treatment with NND to women with GDM would be superior to routine care, but this has never been investigated. The main aim of the randomized controlled trial Intervention with new Nordic DIet in women with GestatiOnal diabetes mellitus (iNDIGO) is to test if the NND compared with usual care will improve glucose control in women with GDM. The iNDIGO study is a randomized parallel, single-blinded, controlled trial. In total, 50 women diagnosed with GDM are recruited and randomized to receive either a NND (intervention) or usual care (control) for 14 days. Participants receive a two-week menu and provided with food bags containing ingredients for dishes and foods to be used. Primary outcome is glycemic control (specifically time in target) measured using continuous glucose monitoring. Compliance to the dietary intervention will be tested using known dietary biomarkers and adherence questionnaires. Maternal socio-demographic and clinical data, biological samples, dietary intake and physical activity will be collected at enrollment and at the end of intervention (30-32 weeks' gestation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: New Nordic DietWomen 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. |
| Control | Active comparator | Other: ControlThe control women receive diet advice according to usual care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women with diagnosis of gestational diabetes in pregnancy wks 24-28.
Key exclusion criteria (4 listed)
- multiple pregnancies
- not understanding/able to read Swedish or English
- unwilling to follow a dietary intervention
- manifest diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Nordic DietThe 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. | Behavioural | Intervention |
| ControlThe 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. | Other | Control |
Primary outcome
Time in Target at gestational week 32
Time frame: At week 32 of pregnancy
Percentage of time in target (TIT) range 3.5-7.8 mmol/L measured with continuous glucose monitoring
15 secondary outcomes
Pregnancy weight gain
Time frame: Pre-pregnant weight up to delivery
Incidence of pregnancy-induced hypertension
Time frame: Up to delivery
Incidence of pre-eclampsia
Time frame: Up to delivery
Prevalence of use of insulin/Metformin treatment
Time frame: Up to delivery
Incidence of preterm delivery
Time frame: Up to 37 completed weeks
Incidence of Caesarean sections
Time frame: Up to delivery
Health-related quality of life
Time frame: Up to 1 year postpartum
Incidence of LGA
Time frame: At delivery
Incidence of shoulder displacement
Time frame: At delivery
Apgar scores measurements
Time frame: At delivery
Additional measurements from continuous glucose monitoring at wk 32
Time frame: At gestational week 32
Additional measurements from continuous glucose monitoring at wk 36
Time frame: At gestational week 36
Incidence of macrosomia
Time frame: At delivery
Nutritional status
Time frame: During pregnancy
Diet quality measuremen¨t
Time frame: Up to delivery
Results and safety
The study was stopped early (reason given: Post-pandemic women did not engage in unnecessary tasks. Changes were made (more languages and sites, short proof-of-concept study, easier recepies, food for whole family, social media, etc. After 4 yr 5 women were recruited and trial terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 35158086Karlsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Winkvist, PhD principal investigator
Göteborg University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Nordic Diet in people with Gestational Diabetes Mellitus, run by Göteborg University at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Post-pandemic women did not engage in unnecessary tasks. Changes were made (more languages and sites, short proof-of-concept study, easier recepies, food for whole family, social media, etc. After 4 yr 5 women were recruited and trial terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Target at gestational week 32 (time frame: At week 32 of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04169243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.