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The MoMMii Study. Diabetes Prevention Intervention on Families With Past Gestational Diabetes (MoMMii)

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ClinicalTrials.gov Identifier: NCT02343354
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
The Lawson Foundation
Information provided by (Responsible Party):
Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Center

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.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus With Baby Delivered Behavioral: Nutrition/physical activity intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The MoMMii Study: Effects of a Multimodal Diabetes Prevention Intervention on Families With a History of Gestational Diabetes
Study Start Date : November 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutrition/physical activity intervention
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.
Behavioral: Nutrition/physical activity intervention
Please see arm description
Other Names:
  • Lifestyle intervention
  • Diabetes prevention intervention




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in fruit and vegetable consumption in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.

  2. Change in physical activity in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.

  3. Change in insulin resistance measure (HOMA-IR) in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.

  4. Change in insulin sensitivity measure (ISI 0,120) in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.

  5. Change in fasting glucose in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.

  6. Change in fasting insulin in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.

  7. Change in systolic blood pressure in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.

  8. Change in diastolic blood pressure in mothers and fathers [ Time Frame: 20-24 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343354


Locations
Canada, Quebec
McGill University Health Centre - Royal Victoria Hosptial
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
The Lawson Foundation
Investigators
Principal Investigator: Kaberi Dasgupta, MD, MSc McGill University and McGill University Health Centre

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaberi Dasgupta, MD, MSc, FRCP (C), Physician-Scientist and Director of Clinical Epidemiology, MUHC, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02343354     History of Changes
Other Study ID Numbers: GRT 2014-35
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Center:
behavioural
diabetes prevention
physical activity
healthy eating
gestational diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications