Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02343354
Study type Interventional
Source McGill University Health Center
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date June 2017

See also
  Status Clinical Trial Phase
Completed NCT01814995 - Motivational Support and Meal Preparation Training to Reduce Vascular Risk After Gestational Diabetes N/A
Recruiting NCT03244579 - Carbohydrate Counting and DASH Intervention and Pregnancy Outcomes Among Women With Gestational Diabetes N/A