Gestational Diabetes Mellitus With Baby DeliveredMoMMiiNCT02343354
The MoMMii Study. Diabetes Prevention Intervention on Families With Past Gestational Diabetes
A study testing Nutrition/physical activity intervention in people with Gestational Diabetes Mellitus With Baby Delivered, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes; their children show more insulin resistance and diabetes compared to offspring of mother without diabetes in pregnancy. An increased diabetes risk is also observed among partner of adult with prediabetes/type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gestational Diabetes Mellitus With Baby Delivered
- What is being tested?
- Nutrition/physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Jun 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prior history of gestational diabetes in the mother
- Ability to speak and read English or French
Who cannot join
- Other forms of diabetes (e.g., type 1 diabetes, type 2 diabetes)
- Current use of antihyperglycemic medication
- Pregnancy or attempting to become pregnant
- Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
- Current smoker
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre - Royal Victoria Hosptial
Montreal, Quebec, H3A 1A1
About this study
Official title: The MoMMii Study: Effects of a Multimodal Diabetes Prevention Intervention on Families With a History of Gestational Diabetes
Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes; their children show more insulin resistance and diabetes compared to offspring of mother without diabetes in pregnancy. An increased diabetes risk is also observed among partner of adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The investigators are now enhancing the program to engage directly the partner (MoMMii program).
In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal diabetes prevention program that includes healthy meal preparation training, discussion of eating and physical activity behaviours and developing home environments that facilitate healthy habits, pedometer-based step count monitoring, and participation in family-based activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise equipment, floor resistance exercises). Participants will be encouraged to communicate between sessions with study personnel and with one another to create a between family support network. All mothers and fathers will participate in five sessions over six months. The investigators will examine changes in health-related behaviours, blood pressure, glucose levels, and insulin sensitivity/resistance in both mothers and fathers.
Read the detailed description
The primary goal of the project is to determine if, among families with a history of gestational diabetes mellitus (GDM) in the mother in the prior five years, a family-based multimodal health behaviour intervention (group cooking and eating/physical activity counselling, telephone-based app and text support, building of peer and within-family social support for health behaviour change) will lead to reductions in post 75g glucose load serum glucose values in mothers and fathers. The previous MoMM pilot study demonstrated an 8% reduction in mothers, similar in magnitude to that observed in a large diabetes prevention trial conducted among adults with impaired glucose tolerance (Tuomieltho et al, N Engl J Med 2001). MoMMii will ascertain if expansion to a family-based approach amplifies effects in mothers and demonstrates impact in fathers and children. Thus, MoMMii will shift the focus from the mother to the family. A systematic review and meta-analysis showed diabetes risk to be shared between spouses (Leong et al, BMC Medicine, 2014). GDM also confers higher risk for insulin resistance and overweight in offspring. Thus, this project plans to create a collaborative home environment that facilitates choices consistent with diabetes prevention for all family members. Sixty-six families will be recruited through GDM clinics at McGill University Health Centre and other centres. Five in-person sessions (meal preparation training, eating and physical activity counselling) will take place once a month at the PERFORM Centre, Concordia University. Each session will involve discussion of strategies to achieve healthy eating, hands-on meal preparation, and group-based physical activity. Sessions will engage couples as well as mothers and fathers separately. 'Healthy living' concepts will be integrated into the on-site childcare structure (meal preparation, games, videos). The intervention team will include a dietitian and kinesiologist. A health coach will facilitate networking among participating families and development of lay group leaders to sustain health behaviour changes between sessions and post program. Outcomes will be evaluated in mothers, fathers (e.g., fasting and post load glucose and insulin resistance measures, fruit/vegetable intake, step counts, eating behaviours, blood pressure) and offspring (dietary/physical activity habits).
- Being tested
- Nutrition/physical activity intervention
- Keywords
- behavioural, diabetes prevention, physical activity, healthy eating, gestational diabetes
- Medical subject headings
- Motor Activity, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition/physical activity interventionBehavioural
Also called Lifestyle intervention, Diabetes prevention intervention
Please see arm description
| Study group | Role | What they receive |
|---|---|---|
| Nutrition/physical activity intervention | Experimental | There will be five in-person group sessions (3 to 4 weeks appart) with on-site child care. Sessions will include preparation of a healthy meal (hands-on) and discussions of mindful eating, balanced meals, portion sizes, and preparing food at home, under a dietitian's supervision. Sessions will also include a one-hour physical activity information/practice session with a kinesiologist. Participants will track daily step counts with a pedometer and aim to eventually reach more than 10,000 steps/day. They will also receive instruction and demonstration from a kinesiologist of some simple resistance exercises they may perform at home. Between sessions, participants will receive advice and support through a study-specific website, telephone calls and phone applications. Receives: Behavioral: Nutrition/physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post 75 gram glucose load 2-hour glucose value in mothers and fathers
Following an overnight fast and venous blood sampling for fasting glucose, a 75 gram glucose solution will be consumed by the participant and two hours later, venous blood will be sampled for a repeat serum glucose assay. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
Measured: 20-24 weeks
Secondary outcomes (8)
Change in fruit and vegetable consumption in mothers and fathers
Estimates of consumption based on food frequency questionnaire data completed by mothers and fathers. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
Measured: 20-24 weeks
Change in physical activity in mothers and fathers
Daily physical activity assessed by accelerometers and pedometer-based step counts in mothers and fathers. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
Measured: 20-24 weeks
Change in insulin resistance measure (HOMA-IR) in mothers and fathers
Homeostatic Assessment of insulin resistance (HOMA-IR) calculated with fasting glucose and fasting insulin values. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
Measured: 20-24 weeks
Change in insulin sensitivity measure (ISI 0,120) in mothers and fathers
Using the ratio of the serum insulin levels at the 0 minute and 120-minute time points, the insulin sensitivity index (ISI 0, 120), another marker of insulin resistance, will be calculated as proposed in Gutt M, Davis CL, Spitzer SB, Llabre MM, Kumar M, Czarnecki EM et al. Validation of the insulin sensitivity index (ISI(0,120)): comparison with other measures. Diabetes Res Clin Pract 2000; 47(3):177-184. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
Measured: 20-24 weeks
Change in fasting glucose in mothers and fathers
Following an overnight fast, venous blood will be sampled for assessment of fasting glucose. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
Measured: 20-24 weeks
Change in fasting insulin in mothers and fathers
Following an overnight fast, venous blood will be sampled for assessment of fasting insulin. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
Measured: 20-24 weeks
Change in systolic blood pressure in mothers and fathers
Systolic blood pressure will assessed with the participant seated in a quiet room with the arm supported. Measurements will be taken with an automated device at 1-minute intervals for 6 sequential measurements. The latter 5 measurements will be averaged. The pre-intervention (average) systolic blood pressure will be subtracted from the post-intervention (average) systolic blood pressure for computation of the change in systolic blood pressure.
Measured: 20-24 weeks
Change in diastolic blood pressure in mothers and fathers
Diastolic blood pressure will assessed with the participant seated in a quiet room with the arm supported. Measurements will be taken with an automated device at 1-minute intervals for 6 sequential measurements. The latter 5 measurements will be averaged. The pre-intervention (average) diastolic blood pressure will be subtracted from the post-intervention (average) diastolic blood pressure for computation of the change in systolic blood pressure.
Measured: 20-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus With Baby DeliveredStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- The Lawson Foundation
- Responsible party
- Principal investigator, Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Kaberi Dasgupta, MD, MSc, Principal investigator, McGill University and McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343354
- Sponsor's protocol ID
- GRT 2014-35
- Acronym
- MoMMii
- Status last verified
- Aug 2025
- First submitted
- 15 Jan 2015
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brazeau AS, Leong A, Meltzer SJ, Cruz R, DaCosta D, Hendrickson-Nelson M, Joseph L, Dasgupta K; MoMM study group. Group-based activities with on-site childcare and online support improve glucose tolerance in women within 5 years of gestational diabetes pregnancy. Cardiovasc Diabetol. 2014 Jun 30;13:104. doi: 10.1186/1475-2840-13-104.
PubMed 24981579Leong A, Rahme E, Dasgupta K. Spousal diabetes as a diabetes risk factor: a systematic review and meta-analysis. BMC Med. 2014 Jan 24;12:12. doi: 10.1186/1741-7015-12-12.
PubMed 24460622Dasgupta K, Da Costa D, Pillay S, De Civita M, Gougeon R, Leong A, Bacon S, Stotland S, Chetty VT, Garfield N, Majdan A, Meltzer S. Strategies to optimize participation in diabetes prevention programs following gestational diabetes: a focus group study. PLoS One. 2013 Jul 4;8(7):e67878. doi: 10.1371/journal.pone.0067878. Print 2013.
PubMed 23861824Brazeau AS, Meltzer SJ, Pace R, Garfield N, Godbout A, Meissner L, Rahme E, Da Costa D, Dasgupta K. Health behaviour changes in partners of women with recent gestational diabetes: a phase IIa trial. BMC Public Health. 2018 May 2;18(1):575. doi: 10.1186/s12889-018-5490-x.
PubMed 29716559
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MoMMii Study: Effects of a Multimodal Diabetes Prevention Intervention on Families With a History of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02343354
- Acronym / sponsor ID
- MoMMii / GRT 2014-35
- Keywords
- behavioural, diabetes prevention, physical activity, healthy eating, gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- The Lawson Foundation
- Study start
- Nov 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Jan 2015 (estimated)
- 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.
Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes; their children show more insulin resistance and diabetes compared to offspring of mother without diabetes in pregnancy. An increased diabetes risk is also observed among partner of adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The investigators are now enhancing the program to engage directly the partner (MoMMii program).
In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal diabetes prevention program that includes healthy meal preparation training, discussion of eating and physical activity behaviours and developing home environments that facilitate healthy habits, pedometer-based step count monitoring, and participation in family-based activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise equipment, floor resistance exercises). Participants will be encouraged to communicate between sessions with study personnel and with one another to create a between family support network. All mothers and fathers will participate in five sessions over six months. The investigators will examine changes in health-related behaviours, blood pressure, glucose levels, and insulin sensitivity/resistance in both mothers and fathers.
Detailed description
The primary goal of the project is to determine if, among families with a history of gestational diabetes mellitus (GDM) in the mother in the prior five years, a family-based multimodal health behaviour intervention (group cooking and eating/physical activity counselling, telephone-based app and text support, building of peer and within-family social support for health behaviour change) will lead to reductions in post 75g glucose load serum glucose values in mothers and fathers. The previous MoMM pilot study demonstrated an 8% reduction in mothers, similar in magnitude to that observed in a large diabetes prevention trial conducted among adults with impaired glucose tolerance (Tuomieltho et al, N Engl J Med 2001). MoMMii will ascertain if expansion to a family-based approach amplifies effects in mothers and demonstrates impact in fathers and children. Thus, MoMMii will shift the focus from the mother to the family. A systematic review and meta-analysis showed diabetes risk to be shared between spouses (Leong et al, BMC Medicine, 2014). GDM also confers higher risk for insulin resistance and overweight in offspring. Thus, this project plans to create a collaborative home environment that facilitates choices consistent with diabetes prevention for all family members. Sixty-six families will be recruited through GDM clinics at McGill University Health Centre and other centres. Five in-person sessions (meal preparation training, eating and physical activity counselling) will take place once a month at the PERFORM Centre, Concordia University. Each session will involve discussion of strategies to achieve healthy eating, hands-on meal preparation, and group-based physical activity. Sessions will engage couples as well as mothers and fathers separately. 'Healthy living' concepts will be integrated into the on-site childcare structure (meal preparation, games, videos). The intervention team will include a dietitian and kinesiologist. A health coach will facilitate networking among participating families and development of lay group leaders to sustain health behaviour changes between sessions and post program. Outcomes will be evaluated in mothers, fathers (e.g., fasting and post load glucose and insulin resistance measures, fruit/vegetable intake, step counts, eating behaviours, blood pressure) and offspring (dietary/physical activity habits).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition/physical activity intervention | Experimental | Behavioral: Nutrition/physical activity interventionThere will be five in-person group sessions (3 to 4 weeks appart) with on-site child care. Sessions will include preparation of a healthy meal (hands-on) and discussions of mindful eating, balanced meals, portion sizes, and preparing food at home, under a dietitian's supervision. Sessions will also include a one-hour physical activity information/practice session with a kinesiologist. Participants will track daily step counts with a pedometer and aim to eventually reach more than 10,000 steps/day. They will also receive instruction and demonstration from a kinesiologist of some simple resistance exercises they may perform at home. Between sessions, participants will receive advice and support through a study-specific website, telephone calls and phone applications. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prior history of gestational diabetes in the mother
- Ability to speak and read English or French
Key exclusion criteria (5 listed)
- Other forms of diabetes (e.g., type 1 diabetes, type 2 diabetes)
- Current use of antihyperglycemic medication
- Pregnancy or attempting to become pregnant
- Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
- Current smoker
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 |
|---|---|---|
| Nutrition/physical activity interventionAlso: Lifestyle intervention, Diabetes prevention interventionPlease see arm description | Behavioural | Nutrition/physical activity intervention |
Primary outcome
Change in post 75 gram glucose load 2-hour glucose value in mothers and fathers
Time frame: 20-24 weeks
Following an overnight fast and venous blood sampling for fasting glucose, a 75 gram glucose solution will be consumed by the participant and two hours later, venous blood will be sampled for a repeat serum glucose assay. The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
8 secondary outcomes
Change in fruit and vegetable consumption in mothers and fathers
Time frame: 20-24 weeks
Change in physical activity in mothers and fathers
Time frame: 20-24 weeks
Change in insulin resistance measure (HOMA-IR) in mothers and fathers
Time frame: 20-24 weeks
Change in insulin sensitivity measure (ISI 0,120) in mothers and fathers
Time frame: 20-24 weeks
Change in fasting glucose in mothers and fathers
Time frame: 20-24 weeks
Change in fasting insulin in mothers and fathers
Time frame: 20-24 weeks
Change in systolic blood pressure in mothers and fathers
Time frame: 20-24 weeks
Change in diastolic blood pressure in mothers and fathers
Time frame: 20-24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 24981579Brazeau AS, Leong A, Meltzer SJ, Cruz R, DaCosta D, Hendrickson-Nelson M, Joseph L, Dasgupta K; MoMM study group. Group-based activities with on-site childcare and online support improve glucose tolerance in women within 5 years of gestational diabetes pregnancy. Cardiovasc Diabetol. 2014 Jun 30;13:104. doi: 10.1186/1475-2840-13-104.
- Background: PubMed 24460622Leong A, Rahme E, Dasgupta K. Spousal diabetes as a diabetes risk factor: a systematic review and meta-analysis. BMC Med. 2014 Jan 24;12:12. doi: 10.1186/1741-7015-12-12.
- Background: PubMed 23861824Dasgupta K, Da Costa D, Pillay S, De Civita M, Gougeon R, Leong A, Bacon S, Stotland S, Chetty VT, Garfield N, Majdan A, Meltzer S. Strategies to optimize participation in diabetes prevention programs following gestational diabetes: a focus group study. PLoS One. 2013 Jul 4;8(7):e67878. doi: 10.1371/journal.pone.0067878. Print 2013.
- Results publication: PubMed 29716559Brazeau AS, Meltzer SJ, Pace R, Garfield N, Godbout A, Meissner L, Rahme E, Da Costa D, Dasgupta K. Health behaviour changes in partners of women with recent gestational diabetes: a phase IIa trial. BMC Public Health. 2018 May 2;18(1):575. doi: 10.1186/s12889-018-5490-x.
- MoMM pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes Mellitus With Baby Delivered
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Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes
Gestational Diabetes Mellitus With Baby Delivered
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.
Kaberi Dasgupta, MD, MSc principal investigator
McGill University and McGill University 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 Nutrition/physical activity intervention in people with Gestational Diabetes Mellitus With Baby Delivered, run by McGill University Health Centre/Research Institute of the McGill University 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 27 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in post 75 gram glucose load 2-hour glucose value in mothers and fathers (time frame: 20-24 weeks). 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 NCT02343354, which also lists 4 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 27 Aug 2025.