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.
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
- Conditions the study is for
- Gestational Diabetes Mellitus With Baby Delivered
- What is being tested?
- Nutrition/Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Nutrition/Physical Activity Intervention | Experimental | There 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.
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)
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
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
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
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
adbominal adiposity
Using DXA measures, we will estimate abdominal adiposity and subtract baseline from post intervention values.
Measured: 16 to 20 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted20 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus With Baby DeliveredStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Kaberi Dasgupta, MD, MSc, Principal investigator, McGill University and McGill University Health Centre
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 23861824Leong 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 24460622Brazeau 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01814995
- Acronym / sponsor ID
- MoMM / CIHR-CAI117789
- Keywords
- behavioural, diabetes prevention, overweight, physical activity, gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition/Physical Activity Intervention | Experimental | Behavioral: Nutrition/Physical Activity InterventionThere 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Prior history of GDM
- Body mass index (BMI) ≥ 24 kg/m2
- Ability to speak and read English or French
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Type 2 diabetes
- Use of antihyperglycemic medication
- Pregnant or planning to become pregnant again in the next year
- Food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition/Physical Activity InterventionAlso: Lifestyle Intervention, Diabetes Prevention InterventionPlease see Arm description. | Behavioural | Nutrition/Physical Activity Intervention |
Primary outcome
percentage change in weight in participant
Time frame: 16 to 20 weeks
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.
33 secondary outcomes
change in BMI
Time frame: 16 to 20 weeks
change in waist circumference
Time frame: 16 to 20 weeks
change in waist to hip ratio
Time frame: 16 to 20 weeks
change in total body fat
Time frame: 16 to 20 weeks
adbominal adiposity
Time frame: 16 to 20 weeks
change in fasting glucose levels
Time frame: 16 to 20 weeks
change in 1-hour glucose level following 75-gram glucose load
Time frame: 16 to 20 weeks
Proportion with elevated 1-hour glucose level following 75-gram glucose load
Time frame: 16 to 20 weeks
change in 2-hour glucose level following 75-gram glucose load
Time frame: 16 to 20 weeks
change in fasting insulin levels
Time frame: 16 to 20 weeks
change in 1-hour insulin level following 75-gram glucose load
Time frame: 16 to 20 weeks
change in 2-hour insulin level following 75-gram glucose load
Time frame: 16 to 20 weeks
change in Homeostatic Model Assessment of insulin resistance (HOMA-IR)
Time frame: 16 to 20 weeks
change in insulin sensitivity index 0, 120 (ISI)
Time frame: 16 to 20 weeks
change in systolic blood pressure
Time frame: 16 to 20 weeks
change in diastolic blood pressure
Time frame: 16 to 20 weeks
change in daily step count
Time frame: 16 to 20 weeks
change in physical activity level
Time frame: 16 to 20 weeks
change in total cholesterol
Time frame: 16 to 20 weeks
change in high density lipoprotein cholesterol
Time frame: 16 to 20 weeks
Change in triglyceride levels
Time frame: 16 to 20 weeks
change in low density lipoprotein cholesterol
Time frame: 16 to 20 weeks
change in total cholesterol to high density lipoprotein cholesterol ratio
Time frame: 16 to 20 weeks
change in weight of participant's spouse
Time frame: 16 to 20 weeks
Change in eating habits
Time frame: 16 to 20 weeks
Change in eating outside of the home
Time frame: 16 to 20 weeks
Change in cooking ability
Time frame: 16 to 20 weeks
Change in fiber intake
Time frame: 16 to 20 weeks
Change in anxiety and depression
Time frame: 16-20 weeks
Change in measure of self-efficacy for eating control
Time frame: 16-20 weeks
Change in perceived stress
Time frame: 16 to 20 weeks
Change in reported physical activity
Time frame: 16 to 20 weeks
Change in mindful eating
Time frame: 16 to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
- Background: PubMed 23861824Dasgupta 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.
- Background: PubMed 24460622Leong 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.
- Results publication: PubMed 24981579Brazeau 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.
- Main resultsLink provided by the sponsor.
- related systematic review (spousal diabetes concordance)Link provided by the sponsor.
- Focus group study that informed intervention designLink provided by the sponsor.
Related trials for Gestational Diabetes Mellitus With Baby Delivered
Not yet recruiting
Time-restricted Eating and High-intensity Interval Training After Gestational Diabetes
Gestational Diabetes Mellitus With Baby Delivered
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaberi Dasgupta, MD, MSc principal investigator
McGill University and McGill University Health Centre
2 sites in 1 country: see every site and its status.
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.