Skip to main content
OpenTrials
Completed

NCT Number: NCT01681147

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Mellitus Behavior Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

2 online nutrition and exercise education classes

Behavioral

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

Self monitoring of blood glucose levels

Behavioral

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 outcomes

  1. Weight Loss

    Time frame: 1 year postpartum

    • 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.

  2. Postpartum Diabetes Screening at One Year

    Time frame: 1 year postpartum

    • 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.

  3. Barriers 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

    • 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 outcomes

  1. Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum

    Time frame: 3 months, 6 months, 9 months, all reported

    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.

  2. Food Frequency Questionnaire

    Time frame: 3 months, 6 months, 9 months, all reported

    The table shows the percent of women eating each food daily or nearly daily.

  3. Exercise Frequency in Women With Gestational Diabetes Post-Partum

    Time frame: 3 months, 6 months, 9 months, all reported

    This table below shows the average hours per week spent on each activity.

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2012
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.