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Gestational Diabetes Mellitus With Baby DeliveredMoMMNCT01814995

Motivational Support and Meal Preparation Training to Reduce Vascular Risk After Gestational Diabetes

A study testing Nutrition/Physical Activity Intervention in people with Gestational Diabetes Mellitus With Baby Delivered, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
What is being tested?
Nutrition/Physical Activity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesCanada
Study dates
Jan 2012to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • McGill University Health Centre

    Montreal, Quebec, H3A 1A1

  • Sir Mortimer Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

Other trials in Canada

About this study

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)

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.

Read the 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.

Being tested
Nutrition/Physical Activity Intervention
Keywords
behavioural, diabetes prevention, overweight, physical activity, gestational diabetes
Medical subject headings
Overweight, Motor Activity, Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition/Physical Activity InterventionBehavioural

    Also called Lifestyle Intervention, Diabetes Prevention Intervention

    Please see Arm description.

Study groups in NCT01814995
Study groupRoleWhat they receive
Nutrition/Physical Activity InterventionExperimentalThere 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.
Receives: Behavioral: Nutrition/Physical Activity Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 16 to 20 weeks

Secondary outcomes (33)
  1. change in BMI

    We will subtract the baseline BMI from the post intervention BMI of the participant. For computation of the BMI values, weight is divided by the square of the height. The latter is assessed with the aid of a stadiometer.

    Measured: 16 to 20 weeks

  2. change in waist circumference

    Waist circumference will be measured midway between the iliac crest and the lower rib margin. We will subtract the baseline value from the post intervention value to compute the change in waist circumference.

    Measured: 16 to 20 weeks

  3. change in waist to hip ratio

    Hip circumference will be measured at the point of greatest posterior extension of the buttocks. Waist to hip ratio will be computed (waist in cm divided by height in cm). The baseline waist to hip ratio will be subtracted from the post intervention waist to hip ratio for computation of the change in waist to hip ratio.

    Measured: 16 to 20 weeks

  4. change in total body fat

    We will perform Dual-Energy X-ray absorptiometry measurements of total body composition (soft lean tissue, bone mineral and fat mass)to estimate the percentage of total body fat content of subjects. We will subtract baseline total body fat from post intervention total body fat to compute change in total body fat.

    Measured: 16 to 20 weeks

  5. adbominal adiposity

    Using DXA measures, we will estimate abdominal adiposity and subtract baseline from post intervention values.

    Measured: 16 to 20 weeks

  6. change in fasting glucose levels

    Following an overnight fast, venous blood will be sampled for assessment of fasting glucose. Baseline values will be subtracted from final values for computation of change in fasting glucose levels.

    Measured: 16 to 20 weeks

  7. change in 1-hour glucose level following 75-gram glucose load

    Following acquistion of fasting venous blood samples, participants will ingest a 75 gram glucose solution. Venous blood will again be sampled for glucose level measurement. We will subtract the baseline 1-hour glucose value from the post intervention 1-hour glucose value to compute change in 1-hour glucose level following 75- gram glucose load. The 60-minute glucose value following the 75-gram glucose load has been demonstrated to be a good predictor of future development of diabetes among those with a normal fasting glucose level.

    Measured: 16 to 20 weeks

  8. Proportion with elevated 1-hour glucose level following 75-gram glucose load

    Following acquistion of fasting venous blood samples, participants will ingest a 75 gram glucose solution. Venous blood will again be sampled for glucose level measurement. The 60-minute glucose value following the 75-gram glucose load has been demonstrated to be a good predictor of future development of diabetes among those with a normal fasting glucose level (i.e., higher risk with glucose values above 8.6 mmol/L). We will calculate the proportion of participants will a 1- hour glucose level above 8.6 mmol/L at baseline and post intervention and will compare these proportions.

    Measured: 16 to 20 weeks

  9. change in 2-hour glucose level following 75-gram glucose load

    Following acquistion of fasting venous blood samples, participants will ingest a 75 gram glucose solution. Venous blood will again be sampled for glucose level measurement at 1 hour and at 2 hours after ingestion. We will subtract the baseline 2-hour glucose value from the post intervention 2-hour glucose value to compute change in 2-hour glucose level following 75- gram glucose load.

    Measured: 16 to 20 weeks

  10. change in fasting insulin levels

    Following an overnight fast, venous blood will be sampled for assessment of fasting insulin. Baseline values will be subtracted from final values for computation of change in fasting insulin levels.

    Measured: 16 to 20 weeks

  11. change in 1-hour insulin level following 75-gram glucose load

    Following acquistion of fasting venous blood samples, participants will ingest a 75 gram glucose solution. Venous blood will again be sampled for insulin level measurement. We will subtract the baseline 1-hour insulin value from the post intervention 1-hour insulin value to compute change in 1-hour insulin level following 75- gram glucose load.

    Measured: 16 to 20 weeks

  12. change in 2-hour insulin level following 75-gram glucose load

    Following acquistion of fasting venous blood samples, participants will ingest a 75 gram glucose solution. Venous blood will again be sampled for insulin level measurement at 1 hour and at 2 hours after ingestion. We will subtract the baseline 2-hour insulin value from the post intervention 2-hour insulin value to compute change in 2-hour insulin level following 75- gram glucose load.

    Measured: 16 to 20 weeks

  13. change in Homeostatic Model Assessment of insulin resistance (HOMA-IR)

    We will use fasting glucose and insulin values to compute a measure of insulin resistance, the Homeostatic Model Assessment (HOMA) [Fasting insulin (microunits/mL) X fasting glucose (mmol/L) divided by 22.5]. We will subtract the baseline value from the post intervention value to compute the change in HOMA-IR.

    Measured: 16 to 20 weeks

  14. change in insulin sensitivity index 0, 120 (ISI)

    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. We will subtract the ISI 0,120 value at baseline from the post intervention value to compute the change in ISI 0,120.

    Measured: 16 to 20 weeks

  15. change in systolic blood pressure

    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 baseline (average) systolic blood pressure will be subtracted from the post intervention (average) systolic blood pressure for computation of the change in systolic blood pressure.

    Measured: 16 to 20 weeks

  16. change in diastolic blood pressure

    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 baseline (average) diastolic blood pressure will be subtracted from the post intervention (average) diastolic blood pressure for computation of the change in systolic blood pressure.

    Measured: 16 to 20 weeks

  17. change in daily step count

    Step counts will be computed at baseline and post intervention assessments using a Yamax SW-200 pedometer, based on one week of recording. The mean daily step count will be computed. The change in average daily step count will be calculated by subtracting the baseline value from the final value.

    Measured: 16 to 20 weeks

  18. change in physical activity level

    Participants will wear an accelerometer (AGGT3X-Plus 512MB GT3X-Plus Triaxial Activity Monitor) at the hip (elastic belt provided) for a 7-day period at baseline and post intervention. From accelerometry data, we will calculate mean sedentary time per day as well as time at light, moderate, and vigorous activity levels. We will compute changes in mean daily time at various activity levels by subtracting baseline from post intervention values.

    Measured: 16 to 20 weeks

  19. change in total cholesterol

    Total cholesterol will be measured using spectrophotometer at baseline and post intervention. The baseline value will be subtract from the post intervention value.

    Measured: 16 to 20 weeks

  20. change in high density lipoprotein cholesterol

    High density lipoprotein cholesterol will be measured using spectrophotometer at baseline and post intervention. The baseline value will be subtract from the post intervention value.

    Measured: 16 to 20 weeks

  21. Change in triglyceride levels

    Triglyceride levels will be measured using spectrophotometer at baseline and post intervention. The baseline value will be subtract from the post intervention value.

    Measured: 16 to 20 weeks

  22. change in low density lipoprotein cholesterol

    The low density lipoprotein cholesterol will be calculated using the Friedewald equation at baseline and post intervention, based on total cholesterol and high density lipoprotein cholesterol values measured using spectrophotometer. The baseline values will be subtracted from post intervention values.

    Measured: 16 to 20 weeks

  23. change in total cholesterol to high density lipoprotein cholesterol ratio

    Total cholesterol and high density lipoprotein cholesterol will be measured using spectrophotometer at baseline and post intervetion; the total cholesterol to high density lipoprotein cholesterol ratio will be computed at both of these time points. The change in this ratio will be computed by subtracting the baseline ratio from the post intervention ratio.

    Measured: 16 to 20 weeks

  24. change in weight of participant's spouse

    We will subtract the post intervention weight from the baseline weight to compute the change in weight (participant report). We will divide this value by the baseline weight to compute the percentage change in weight from baseline.

    Measured: 16 to 20 weeks

  25. Change in eating habits

    We will use the nutritional measures interview from the baseline and post-intervention assessments; we will use the food groups estimation (for both fruits and vegetables separately and combined, as well as Meat and Alternatives, Milk and Alternatives, Grains products) by portions, the water intake estimation in mL, the energy in kcal in the 24 hour recall at both of these time points and subtract the baseline values from the post intervention values.

    Measured: 16 to 20 weeks

  26. Change in eating outside of the home

    During the baseline and the post-intervention interviews, we will be asking the participants how many times, on average, they eat outside of the home per month. We will subtract the post-intervention value from the baseline value to see the change in eating out.

    Measured: 16 to 20 weeks

  27. Change in cooking ability

    During the baseline and post-intervention assessments, we ask them about their ability to cook from basic ingredients. We have given a value from 1-7 for the responses to this question, and will calculate the change in this value by subtracting the post-intervention response from the baseline response.

    Measured: 16 to 20 weeks

  28. Change in fiber intake

    Using the eaTRACKER.ca website to track participant food intake, we will take the average of the first month's fiber intake to the last month's fiber intake and subtract the first month average to the last month average to determine the change.

    Measured: 16 to 20 weeks

  29. Change in anxiety and depression

    Using the "Hospital Anxiety and Depression scale" (HADS), Zigmond \& Snaith, 1983, we will score the participant responses (a total of 21 for anxiety and a total of 21 for depression), during both the baseline and the post-intervention assessments. We will then subtract the baseline values from the post-intervention values to calculate the change in anxiety and depression.

    Measured: 16-20 weeks

  30. Change in measure of self-efficacy for eating control

    The Weight Efficacy Life-Style Questionnaire (WEL) will be used during baseline and the post-intervention assessments. We will then use the methods outlined (Clark et al., 1991) to yield 5 sub-scale scores that measure "negative emotions (e.g., eating when sad or anxious), availability (e.g., eating when food is readily available, such as at a party), social pressure (e.g., declining food when others are encouraging eating), physical discomfort (e.g., eating when fatigued or in pain), and positive activities (e.g., eating when watching TV or reading)" (Dutton, GR, et al. 2004). The baseline values will be subtracted from the post-intervention values to yield the change.

    Measured: 16-20 weeks

  31. Change in perceived stress

    Using the perceived stress scale questionnaire (Cohen, S. and Williamson, G. Perceived Stress in a Probability Sample of the United States, 1988.), we will score the responses from the participants at the baseline and post-intervention assessments and calculate the change by subtracting the score of the baseline assessment from the post-intervention assessment.

    Measured: 16 to 20 weeks

  32. Change in reported physical activity

    Using the "International Physical Activity Questionnaire", we will assess the change from the baseline and post-intervention reported physical activity. We will score the responses using the methods outlined for this questionnaire (http://www.ipaq.ki.se/scoring.htm) and subtract the baseline score from the post-intervention score to report the change.

    Measured: 16 to 20 weeks

  33. Change in mindful eating

    During the baseline and the post-intervention assessments, we will be using the "mindful eating questionnaire (MEQ)" (Framson, C., et al , 2009), to measure mindful eating. The change will be calculated by subtracting the baseline scores from the post-intervention scores.

    Measured: 16 to 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2013 (estimated)
  2. Study startJan 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01814995
Sponsor's protocol ID
CIHR-CAI117789
Acronym
MoMM
Status last verified
Sep 2014
First submitted
18 Mar 2013
Last updated
11 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23861824
  • 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.

    PubMed 24460622
  • 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.

    PubMed 24981579

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition/Physical Activity Intervention in people with Gestational Diabetes Mellitus With Baby Delivered, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage change in weight in participant (time frame: 16 to 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01814995, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.

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