Clinical trial NCT01681147: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational Diabetes
postpartum
nutrition
exercise
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2012-09-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Weight Loss
timeFrame: 1 year postpartum
measure: Postpartum Diabetes Screening at One Year
timeFrame: 1 year postpartum
measure: Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
timeFrame: Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported
Secondary outcomes:
measure: Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
timeFrame: 3 months, 6 months, 9 months, all reported
measure: Food Frequency Questionnaire
timeFrame: 3 months, 6 months, 9 months, all reported
measure: Exercise Frequency in Women With Gestational Diabetes Post-Partum
timeFrame: 3 months, 6 months, 9 months, all reported
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Florence Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: