Gestational Diabetes MellitusNCT04272840
The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus
A study testing Low Glycemic Index Education in people with Gestational Diabetes Mellitus, run by IWK Health Centre at 1 site in Canada.
Trial summary
Gestational Diabetes Mellitus (GDM) incidence is increasing worldwide, and within Canada, the Atlantic provinces statistically have been found to have highest prevalence of diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Low Glycemic Index Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 24 Oct 2019to 30 Aug 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Of or over 18 years of age
- Diagnosed with GDM according to Diabetes Canada
- At or over than 20 weeks gestation
- At or less than 32 weeks gestation
- Being followed at IWK Health Centre
- Willing and able to give informed consent
- Willing and able to complete study protocol
- Currently living in Nova Scotia
Who cannot join
- have been diagnosed with acute or chronic illness, other than GDM and PCOS, that may impact carbohydrate digestion metabolism.
- are currently taking a medication (other than insulin) that may affect carbohydrate metabolism.
- have multi-fetal pregnancy in current pregnancy.
- have insurmountable language barriers.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Shannan Grant, PDt,MSc,PhD, (902)457-5400, shannan.grant@iwk.nshealth.ca
Julianne LeBlanc, MSc Student, (902)470-6532, julianne.leblanc@iwk.nshealth.ca
About this study
Official title: Adapting a National Glycemic Index Education Platform for Nova Scotian Patients and Clinicians Treating Gestational Diabetes Mellitus Using Distance Education Strategies.
Gestational Diabetes Mellitus (GDM) incidence is increasing worldwide, and within Canada, the Atlantic provinces statistically have been found to have highest prevalence of diabetes. Increasing evidence supports the benefit of following a low glycaemic index (GI) diet in GDM and the Canadian Diabetes Guidelines recommends replacing high GI foods for low GI foods. Despite recommendation to adapt a low GI diet in GDM, there are limitations and barriers recognized to GI utility largely focused on knowledge translation. There is sufficient research to support a low GI diet in benefiting outcomes of GDM, therefore the GI in GDM Online trial will investigate the feasibility and effectiveness of a distance low GI education intervention, adapted from Diabetes Canada's GI materials, on producing a difference in average dietary GI between a group with the intervention and standard care.
Read the detailed description
The incidence of Gestational Diabetes Mellitus (GDM) has been progressively increasing worldwide, with a global prevalence of gestational hyperglycaemia estimated at 16.9%. In Canada, Atlantic provinces have been recorded with the highest prevalence of diabetes at 6%. The Diabetes Canada Practice Guidelines recommends the low glycemic index (GI) diet to type 1 and 2 diabetes mellitus and has recently updated its guidelines to include a recommendation for GDM. This said, barriers to GI knowledge translation have been identified. This study uses a prospective parallel randomized control trial design. Procedures and materials have been adapted from NCT01589757. The Kirkpatrick Model (Reaction, Learning, Behaviour, and Results) informed intervention development and evaluation strategies. The purpose of this study is to evaluate whether a distance low GI education intervention, adapted from Diabetes Canada's GI education materials, will significantly yield a lower average GI (primary outcome) in participants than traditional standard care medical nutrition therapy for Gestational Diabetes Mellitus. We hypothesize that participants who receive the low GI intervention will have a lower dietary GI than those who received usual IWK standard care for GDM.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Low Glycemic Index Education
- Keywords
- Gestational Diabetes, Glycaemic or Glycemic Index, Nutrition, Education, Behaviour
- Medical subject headings
- Diabetes, Gestational, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic Index EducationBehavioural
Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record). |
| Low Glycemic Index | Experimental | Standard care + Glycemic Index. Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record). Diabetes Canada and Dietitian's Canada resources on glycemic index will also be reviewed: the Glycemic Index Food Guide, Flip Cards, and Recipes. Receives: Behavioral: Low Glycemic Index Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer/KM Level 3: Change in average dietary GI
Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum
Measured: From baseline to 4-6 weeks postpartum
Secondary outcomes (8)
Satisfaction/ KM Level 1: Reaction
Mixed form Questionnaire (GIQ): Close ended format with True or False, Multiple Choice, and Likert Scale choices. Open-ended questions for feedback.
Measured: From baseline to 4-6 weeks postpartum
Knowledge/KM Level 2: Learning
Average Quiz Score: Close-ended format, Scored by correct answers.
Measured: From baseline to 4-6 weeks postpartum
Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change)
Mixed form Questionnaire (GIQ): Close ended format using Likert Scale and True or False choices. Open-ended questions for feedback.
Measured: From 4-6 weeks post-intervention to 4-6 weeks post-partum
Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range)
Medical Record (standard care 2-4 time-points per day)
Measured: From Baseline to 4-6 weeks post-partum
Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status)
Mixed-form Questionnaire (GIQ) and Medical Chart
Measured: Baseline
Maternal Height
Medical Record, measured in cm.
Measured: Baseline
Maternal Pre-Pregnancy body weight
Medical Record, measured in kg.
Measured: Baseline
Maternal Weight, during pregnancy
Medical Record, measured in kg.
Measured: From Baseline to 4-6 weeks post-partum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start24 Oct 2019
- Primary completion31 May 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Prospective Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Saint Vincent University, Dalhousie University, The Hospital for Sick Children
- Responsible party
- Principal investigator, Shannan Grant, IWK Health Centre
- Investigators
- Shannan Grant, PhD, PDt, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272840
- Sponsor's protocol ID
- GI in GDM Online
- Status last verified
- Mar 2022
- First submitted
- 20 Oct 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diabetes Canada Clinical Practice Guidelines Expert Committee; Feig DS, Berger H, Donovan L, Godbout A, Kader T, Keely E, Sanghera R. Diabetes and Pregnancy. Can J Diabetes. 2018 Apr;42 Suppl 1:S255-S282. doi: 10.1016/j.jcjd.2017.10.038. No abstract available.
PubMed 29650105Draffin CR, Alderdice FA, McCance DR, Maresh M, Harper Md Consultant Physician R, McSorley O, Holmes VA. Exploring the needs, concerns and knowledge of women diagnosed with gestational diabetes: A qualitative study. Midwifery. 2016 Sep;40:141-7. doi: 10.1016/j.midw.2016.06.019. Epub 2016 Jun 29.
PubMed 27553869Layes, A. The Burden of Diabetes in Atlantic Canada. Public Health Agency of Canada, Atlantic Regional Office; 2011.
Grant SM, Wolever TMS. Perceived barriers to application of glycaemic index: valid concerns or lost in translation? Nutrients. 2011 Mar;3(3):330-340. doi: 10.3390/nu3030330. Epub 2011 Feb 28.
PubMed 22254100Johnston S, Coyer FM, Nash R. Kirkpatrick's Evaluation of Simulation and Debriefing in Health Care Education: A Systematic Review. J Nurs Educ. 2018 Jul 1;57(7):393-398. doi: 10.3928/01484834-20180618-03.
PubMed 29958308
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a National Glycemic Index Education Platform for Nova Scotian Patients and Clinicians Treating Gestational Diabetes Mellitus Using Distance Education Strategies.
- ClinicalTrials.gov ID
- NCT04272840
- Acronym / sponsor ID
- GI in GDM Online
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational Diabetes, Glycaemic or Glycemic Index, Nutrition, Education, Behaviour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Mount Saint Vincent University, Dalhousie University, The Hospital for Sick Children
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 17 Feb 2020 (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.
Gestational Diabetes Mellitus (GDM) incidence is increasing worldwide, and within Canada, the Atlantic provinces statistically have been found to have highest prevalence of diabetes. Increasing evidence supports the benefit of following a low glycaemic index (GI) diet in GDM and the Canadian Diabetes Guidelines recommends replacing high GI foods for low GI foods. Despite recommendation to adapt a low GI diet in GDM, there are limitations and barriers recognized to GI utility largely focused on knowledge translation. There is sufficient research to support a low GI diet in benefiting outcomes of GDM, therefore the GI in GDM Online trial will investigate the feasibility and effectiveness of a distance low GI education intervention, adapted from Diabetes Canada's GI materials, on producing a difference in average dietary GI between a group with the intervention and standard care.
Detailed description
The incidence of Gestational Diabetes Mellitus (GDM) has been progressively increasing worldwide, with a global prevalence of gestational hyperglycaemia estimated at 16.9%. In Canada, Atlantic provinces have been recorded with the highest prevalence of diabetes at 6%. The Diabetes Canada Practice Guidelines recommends the low glycemic index (GI) diet to type 1 and 2 diabetes mellitus and has recently updated its guidelines to include a recommendation for GDM. This said, barriers to GI knowledge translation have been identified. This study uses a prospective parallel randomized control trial design. Procedures and materials have been adapted from NCT01589757. The Kirkpatrick Model (Reaction, Learning, Behaviour, and Results) informed intervention development and evaluation strategies. The purpose of this study is to evaluate whether a distance low GI education intervention, adapted from Diabetes Canada's GI education materials, will significantly yield a lower average GI (primary outcome) in participants than traditional standard care medical nutrition therapy for Gestational Diabetes Mellitus. We hypothesize that participants who receive the low GI intervention will have a lower dietary GI than those who received usual IWK standard care for GDM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record). |
| Low Glycemic Index | Experimental | Behavioral: Low Glycemic Index EducationStandard care + Glycemic Index. Participants will attend a 30-45 min workshop. Trainees will review Diabetes Canada Clinical Practice Guidelines Job Aids (Just the Basics, the Handy Portion Guide, and Basic Carbohydrate Counting) and teach data provision skills (how to complete a three day diet record). Diabetes Canada and Dietitian's Canada resources on glycemic index will also be reviewed: the Glycemic Index Food Guide, Flip Cards, and Recipes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Of or over 18 years of age
- Diagnosed with GDM according to Diabetes Canada
- At or over than 20 weeks gestation
- At or less than 32 weeks gestation
- Being followed at IWK Health Centre
Key exclusion criteria (4 listed)
- have been diagnosed with acute or chronic illness, other than GDM and PCOS, that may impact carbohydrate digestion metabolism.
- are currently taking a medication (other than insulin) that may affect carbohydrate metabolism.
- have multi-fetal pregnancy in current pregnancy.
- have insurmountable language barriers.
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 |
|---|---|---|
| Low Glycemic Index EducationEducational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations. | Behavioural | Low Glycemic Index |
Primary outcome
Transfer/KM Level 3: Change in average dietary GI
Time frame: From baseline to 4-6 weeks postpartum
Average dietary GI; diet record at baseline, 4-6 weeks post-intervention, 4-6 weeks postpartum
8 secondary outcomes
Satisfaction/ KM Level 1: Reaction
Time frame: From baseline to 4-6 weeks postpartum
Knowledge/KM Level 2: Learning
Time frame: From baseline to 4-6 weeks postpartum
Acceptability and Applicability of Education/KM Level 3: Transfer (Behaviour Change)
Time frame: From 4-6 weeks post-intervention to 4-6 weeks post-partum
Results/KM Level 4: Glycemic Control (rate of Self-monitored blood glucose levels within range)
Time frame: From Baseline to 4-6 weeks post-partum
Maternal Demographics (eg. age, ethnicity, language spoken, education level and work status)
Time frame: Baseline
Maternal Height
Time frame: Baseline
Maternal Pre-Pregnancy body weight
Time frame: Baseline
Maternal Weight, during pregnancy
Time frame: From Baseline to 4-6 weeks post-partum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 29650105Diabetes Canada Clinical Practice Guidelines Expert Committee; Feig DS, Berger H, Donovan L, Godbout A, Kader T, Keely E, Sanghera R. Diabetes and Pregnancy. Can J Diabetes. 2018 Apr;42 Suppl 1:S255-S282. doi: 10.1016/j.jcjd.2017.10.038. No abstract available.
- Background: PubMed 27553869Draffin CR, Alderdice FA, McCance DR, Maresh M, Harper Md Consultant Physician R, McSorley O, Holmes VA. Exploring the needs, concerns and knowledge of women diagnosed with gestational diabetes: A qualitative study. Midwifery. 2016 Sep;40:141-7. doi: 10.1016/j.midw.2016.06.019. Epub 2016 Jun 29.
- BackgroundLayes, A. The Burden of Diabetes in Atlantic Canada. Public Health Agency of Canada, Atlantic Regional Office; 2011.
- Background: PubMed 22254100Grant SM, Wolever TMS. Perceived barriers to application of glycaemic index: valid concerns or lost in translation? Nutrients. 2011 Mar;3(3):330-340. doi: 10.3390/nu3030330. Epub 2011 Feb 28.
- Background: PubMed 29958308Johnston S, Coyer FM, Nash R. Kirkpatrick's Evaluation of Simulation and Debriefing in Health Care Education: A Systematic Review. J Nurs Educ. 2018 Jul 1;57(7):393-398. doi: 10.3928/01484834-20180618-03.
- Statistics Canada: Diabetes (2017)Link provided by the sponsor.
- 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.
Shannan Grant, PhD, PDt principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Index Education in people with Gestational Diabetes Mellitus, run by IWK Health Centre at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannan Grant, PhD, PDt (902-457-5400, shannan.grant2@msvu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfer/KM Level 3: Change in average dietary GI (time frame: From baseline to 4-6 weeks postpartum). 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 NCT04272840, which also lists 5 linked publications.
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 31 Mar 2022.