Motivational Support and Meal Preparation Training to Reduce Vascular Risk After Gestational Diabetes
MoMM
Combining Motivational Support, Meal Preparation Training, and a Tapering Course of Meal Replacements To Achieve Vascular Risk Reduction in Women With a Gestational Diabetes History (MoMM)
1 other identifier
interventional
36
1 country
2
Brief Summary
Women with a history of 'diabetes in pregnancy' or Gestational Diabetes (GDM) have a high risk for type 2 diabetes later in life. This can often be prevented, however, with improvements in eating habits and higher physical activity levels. However, many women find it difficult to alter their lifestyle habits, especially if they have young children. In adults with type 2 diabetes, the investigators have been studying the effects of combining nutrition education with meal preparation training and pedometer-based self-monitoring to improve eating habits and increase activity levels. The investigators have shown that such a strategy can reduce hemoglobin A1C by 0.3% and correlates with small reductions in weight (Dasgupta et al, International Journal of Behavioural Nutrition and Physical Activity, 2012). In developing the present interventional study, we presented this strategy to women with a GDM history and asked them how they would modify it to suit their needs. They expressed strong interest in such an approach but emphasized a need to involve their spouses and provide childcare support. They did not express interest in use of meal replacements. Therefore, in MoMM-intervention phase, the investigators will examine the effects of a once per month (4 session) program combined with Internet/telephone-based support. The four sessions with include meal preparation training, strategies to limit mindless eating and improve meal content and portion control. All sessions will offer child care. Two sessions will involve spouses. The investigators will assess effects on weight, BMI, DXA measures of fat, and measures of insulin resistance and blood pressure. This single-arm intervention study may lead ultimately to a randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedSeptember 11, 2014
September 1, 2014
1.7 years
March 18, 2013
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percentage change in weight in participant
Women with a GDM history within the past 5 years are enrolled with a BMI at or above 24 kg/m2. Weight will be measured to the nearest 0.1 kilogram with an automated scale. We will subtract the post intervention weight from the baseline weight to compute the change in weight. We will divide this value by the baseline weight to compute the percentage change in weight from baseline.
16 to 20 weeks
Secondary Outcomes (33)
change in BMI
16 to 20 weeks
change in waist circumference
16 to 20 weeks
change in waist to hip ratio
16 to 20 weeks
change in total body fat
16 to 20 weeks
adbominal adiposity
16 to 20 weeks
- +28 more secondary outcomes
Study Arms (1)
Nutrition/Physical Activity Intervention
EXPERIMENTALThere will be four in-person group sessions (1/month), two including the participants' partners, and all 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 and telephone calls.
Interventions
Please see Arm description.
Eligibility Criteria
You may qualify if:
- Prior history of GDM
- Body mass index (BMI) ≥ 24 kg/m2
- Ability to speak and read English or French
You may not qualify if:
- Type 1 diabetes
- Type 2 diabetes
- Use of antihyperglycemic medication
- Pregnant or planning to become pregnant again in the next year
- Food allergies
- Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
- Current smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
McGill University Health Centre
Montreal, Quebec, H3A 1A1, Canada
Sir Mortimer Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Related Publications (3)
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.
PMID: 23861824BACKGROUNDLeong 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.
PMID: 24460622BACKGROUNDBrazeau 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.
PMID: 24981579RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaberi Dasgupta, MD, MSc
McGill University and McGill University Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, McGill University
Study Record Dates
First Submitted
March 18, 2013
First Posted
March 20, 2013
Study Start
January 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
September 11, 2014
Record last verified: 2014-09