Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether women who have had gestational diabetes mellitus (GDM) will make healthier lifestyle choices, achieve weight goals, and complete postpartum care assessments after receiving two online classes on healthy nutrition and exercise classes at 6 weeks - 3 months and at 9 months postpartum.

Detailed Description
-----------------
For this pilot study, we propose to conduct a 3-grouped randomized controlled trial to evaluate whether a 1 ½ to 2 hour on-line nutrition and physical activity intervention +/- block testing of blood glucoses fasting and 2 hours after each meal for 4 days/month from starting at 3 months postpartum and concluding at 9 months postpartum will: 1) improve adherence to the receipt of diabetes screening at 12 months postpartum through the recommended 75 gram 2 hour oral glucose tolerance test (OGTT) or fasting blood glucose test, 2) lower glucose values on the 75 gram 2 hour oral glucose tolerance test or fasting blood glucose test and 3) improve attainment of weight loss targets among women with a recent history of GDM. Patients will participate in an online nutrition and physical activity class from 6 weeks to 3 months and 9 months for women assigned to both groups 2 and 3. For those women assigned to group 3, they will also do block testing using an assigned blood glucose meter and test strips 4 times a day for 4 consecutive days each month, starting at 3 months and ending at 9 months. Women will have the option of submitting meter blood glucose data via e-mailed logs or downloading directly to the clinic using Diasend software. Once downloaded, the Diasend software will create a PDF document with all recorded blood glucose values. For purposes of this study, we will obtain a Diasend account specific to this study, which will allow women to download blood glucose information with an anonymous unique identifier that can be accessed by the study's Principal Investigator and the Collaborative Institutional Training Initiative (CITI)-certified, International Review Board (IRB)-approved research assistant. Upon accessing the PDF document with the blood glucose meter information, both the PI and the Research Assistant can link blood glucose data with questionnaire and other health information collected in this study through the unique identifiers.

Official Title
-----------------
Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes

Conditions
-----------------
Gestational Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: 2 online nutrition and exercise education classes
* Behavioral: Self monitoring of blood glucose levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational Diabetes Age between 21 and 45 years Preconception BMI 19-40 Seen for at least 2 visits in the Diabetes in Pregnancy Program during their pregnancy Singleton pregnancy Exclusion Criteria: Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram 2 hour OGTT BMI >40 Multiple gestation (i.e., twins, triplets, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Standard postpartum care after a pregnancy with gestational diabetes | |
| Experimental: Standard Care+Education Classes<br>Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes | Behavioral: 2 online nutrition and exercise education classes<br>* Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months<br>|
| Experimental: Standard Care+Education Classes+Glucose Monitoring<br>Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes Self monitoring of blood glucose levels | Behavioral: 2 online nutrition and exercise education classes<br>* Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months<br>Behavioral: Self monitoring of blood glucose levels<br>* Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | 1. Postpartum weight loss (target 7% less than the pre-pregnancy weight for overweight/obese women and back to pre-pregnancy weight for normal BMI women). This will be based on medical record information on pre-pregnancy weight and self-reported or health-care provider reported weight at 12 months. | 1 year postpartum | 
| Postpartum Diabetes Screening at One Year | Adherence to diabetes screening using the 75 gram 2 hour oral glucose tolerance test (OGTT) or fasting blood glucose at 12 months (+/- 3 months). Lab results from the fasting glucose test or results from a 75 gram 2 hour OGTT at 12 months among women who choose to take the diabetes screening test. | 1 year postpartum | 
| Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals | 2. Determine to what extent barriers to health impact adherence rates to post partum screening and weight loss targets through a web-based questionnaire collected on the 6 weeks to 3 months, 6, 9, and 12 month questionnaires. These questionnaires will assess whether: lack of self care, perception of high infant care giving needs, fear of diabetes diagnosis and postpartum depressive symptoms, difficulty accessing medical care, dissatisfaction with medical care or primary care physician not recommending screening are associated with poorer adherence to diabetes screening guidelines and weight loss goals. | Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum | Determine to what extent types of food products and amount of exercise frequented by women with gestational diabetes postpartum impacted adherence rates to weight loss targets through a web-based questionnaire collected at the 3 month, 6 month and 9 month follow-up. These questionnaires will assess whether eating patterns associated with poorer adherence to diabetes screening guidelines and weight loss goals. | 3 months, 6 months, 9 months, all reported | 
| Food Frequency Questionnaire | The table shows the percent of women eating each food daily or nearly daily. | 3 months, 6 months, 9 months, all reported | 
| Exercise Frequency in Women With Gestational Diabetes Post-Partum | This table below shows the average hours per week spent on each activity. | 3 months, 6 months, 9 months, all reported | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational Diabetes, postpartum, nutrition, exercise