Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Primary Purpose
Gestational Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes Mellitus focused on measuring Gestational Diabetes, postpartum, nutrition, exercise
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.)
Sites / Locations
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard Care
Standard Care+Education Classes
Standard Care+Education Classes+Glucose Monitoring
Arm Description
Standard postpartum care after a pregnancy with gestational diabetes
Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes
Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes Self monitoring of blood glucose levels
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Food Frequency Questionnaire
The table shows the percent of women eating each food daily or nearly daily.
Exercise Frequency in Women With Gestational Diabetes Post-Partum
This table below shows the average hours per week spent on each activity.
Full Information
NCT ID
NCT01681147
First Posted
September 4, 2012
Last Updated
July 14, 2022
Sponsor
Joslin Diabetes Center
Collaborators
Roche Diagnostics
1. Study Identification
Unique Protocol Identification Number
NCT01681147
Brief Title
Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Official Title
Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
January 20, 2018 (Actual)
Study Completion Date
September 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Roche Diagnostics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational Diabetes, postpartum, nutrition, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard postpartum care after a pregnancy with gestational diabetes
Arm Title
Standard Care+Education Classes
Arm Type
Experimental
Arm Description
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Arm Title
Standard Care+Education Classes+Glucose Monitoring
Arm Type
Experimental
Arm Description
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
Intervention Type
Behavioral
Intervention Name(s)
2 online nutrition and exercise education classes
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Self monitoring of blood glucose levels
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight Loss
Description
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.
Time Frame
1 year postpartum
Title
Postpartum Diabetes Screening at One Year
Description
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.
Time Frame
1 year postpartum
Title
Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
Description
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.
Time Frame
Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported
Secondary Outcome Measure Information:
Title
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Description
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.
Time Frame
3 months, 6 months, 9 months, all reported
Title
Food Frequency Questionnaire
Description
The table shows the percent of women eating each food daily or nearly daily.
Time Frame
3 months, 6 months, 9 months, all reported
Title
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Description
This table below shows the average hours per week spent on each activity.
Time Frame
3 months, 6 months, 9 months, all reported
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Brown, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
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