Clinical trial NCT02343354: The MoMMii Study. Diabetes Prevention Intervention on Families With Past Gestational Diabetes
Official title: The MoMMii Study: Effects of a Multimodal Diabetes Prevention Intervention on Families With a History of Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus With Baby Delivered
Keywords: behavioural
diabetes prevention
physical activity
healthy eating
gestational diabetes
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: The Lawson Foundation
First posted: 2015-01-22
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

1. Prior history of gestational diabetes in the mother
2. Ability to speak and read English or French

Exclusion Criteria:

1. Other forms of diabetes (e.g., type 1 diabetes, type 2 diabetes)
2. Current use of antihyperglycemic medication
3. Pregnancy or attempting to become pregnant
4. Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
5. Current smoker

Primary outcomes:
measure: Change in post 75 gram glucose load 2-hour glucose value in mothers and fathers
timeFrame: 20-24 weeks
Secondary outcomes:
measure: Change in fruit and vegetable consumption in mothers and fathers
timeFrame: 20-24 weeks
measure: Change in physical activity in mothers and fathers
timeFrame: 20-24 weeks
measure: Change in insulin resistance measure (HOMA-IR) in mothers and fathers
timeFrame: 20-24 weeks
measure: Change in insulin sensitivity measure (ISI 0,120) in mothers and fathers
timeFrame: 20-24 weeks
measure: Change in fasting glucose in mothers and fathers
timeFrame: 20-24 weeks
measure: Change in fasting insulin in mothers and fathers
timeFrame: 20-24 weeks
measure: Change in systolic blood pressure in mothers and fathers
timeFrame: 20-24 weeks
measure: Change in diastolic blood pressure in mothers and fathers
timeFrame: 20-24 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre - Royal Victoria Hosptial
state: Quebec
Study officials:
affiliation: McGill University and McGill University Health Centre
name: Kaberi Dasgupta, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Leong 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.
citation: Dasgupta 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.
citation: Brazeau 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.