Clinical trial NCT01814995: Motivational Support and Meal Preparation Training to Reduce Vascular Risk After Gestational Diabetes
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus With Baby Delivered
Keywords: behavioural
diabetes prevention
overweight
physical activity
gestational diabetes
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-03-20
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: The investigators have adopted a single-arm intervention pilot study to assess the potential effects of a nutrition/physical activity behavioural intervention in women with a history of GDM within the past 5 years. The investigators have designed the intervention to include in-person sessions- but at a feasible frequency for busy mothers- as well as telephone calls and an on-line discussion forum, to provide an ongoing source of support, information, and accountability. Further, participants' partners will be invited to some of the in-person sessions and childcare will be provided on-site. Importantly, there are no meal replacements included, despite the study title, because focus group discussions indicated that this was not of interest to the target population.

The investigators will hold in-person sessions at a frequency of once per month over a 4-month period. In addition to the in-person, on-site sessions, we will arrange for participants to have in a grocery store 'tour' led by a student from the McGill School of Dietetics and Human Nutrition BSc program. This will allow a review of label reading and interpretation as well as tips on produce selection. Details of the intervention are provided under the trial arm section below.

Eligibility criteria: Inclusion Criteria:

1. Prior history of GDM
2. Body mass index (BMI) ≥ 24 kg/m2
3. Ability to speak and read English or French

Exclusion Criteria:

1. Type 1 diabetes
2. Type 2 diabetes
3. Use of antihyperglycemic medication
4. Pregnant or planning to become pregnant again in the next year
5. Food allergies
6. Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
7. Current smoker

Primary outcomes:
measure: percentage change in weight in participant
timeFrame: 16 to 20 weeks
Secondary outcomes:
measure: change in BMI
timeFrame: 16 to 20 weeks
measure: change in waist circumference
timeFrame: 16 to 20 weeks
measure: change in waist to hip ratio
timeFrame: 16 to 20 weeks
measure: change in total body fat
timeFrame: 16 to 20 weeks
measure: adbominal adiposity
timeFrame: 16 to 20 weeks
measure: change in fasting glucose levels
timeFrame: 16 to 20 weeks
measure: change in 1-hour glucose level following 75-gram glucose load
timeFrame: 16 to 20 weeks
measure: Proportion with elevated 1-hour glucose level following 75-gram glucose load
timeFrame: 16 to 20 weeks
measure: change in 2-hour glucose level following 75-gram glucose load
timeFrame: 16 to 20 weeks
measure: change in fasting insulin levels
timeFrame: 16 to 20 weeks
measure: change in 1-hour insulin level following 75-gram glucose load
timeFrame: 16 to 20 weeks
measure: change in 2-hour insulin level following 75-gram glucose load
timeFrame: 16 to 20 weeks
measure: change in Homeostatic Model Assessment of insulin resistance (HOMA-IR)
timeFrame: 16 to 20 weeks
measure: change in insulin sensitivity index 0, 120 (ISI)
timeFrame: 16 to 20 weeks
measure: change in systolic blood pressure
timeFrame: 16 to 20 weeks
measure: change in diastolic blood pressure
timeFrame: 16 to 20 weeks
measure: change in daily step count
timeFrame: 16 to 20 weeks
measure: change in physical activity level
timeFrame: 16 to 20 weeks
measure: change in total cholesterol
timeFrame: 16 to 20 weeks
measure: change in high density lipoprotein cholesterol
timeFrame: 16 to 20 weeks
measure: Change in triglyceride levels
timeFrame: 16 to 20 weeks
measure: change in low density lipoprotein cholesterol
timeFrame: 16 to 20 weeks
measure: change in total cholesterol to high density lipoprotein cholesterol ratio
timeFrame: 16 to 20 weeks
measure: change in weight of participant's spouse
timeFrame: 16 to 20 weeks
measure: Change in eating habits
timeFrame: 16 to 20 weeks
measure: Change in eating outside of the home
timeFrame: 16 to 20 weeks
measure: Change in cooking ability
timeFrame: 16 to 20 weeks
measure: Change in fiber intake
timeFrame: 16 to 20 weeks
measure: Change in anxiety and depression
timeFrame: 16-20 weeks
measure: Change in measure of self-efficacy for eating control
timeFrame: 16-20 weeks
measure: Change in perceived stress
timeFrame: 16 to 20 weeks
measure: Change in reported physical activity
timeFrame: 16 to 20 weeks
measure: Change in mindful eating
timeFrame: 16 to 20 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer Davis Jewish General Hospital
state: Quebec
Study officials:
affiliation: McGill University and McGill University Health Centre
name: Kaberi Dasgupta, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.