Gestational Diabetes MellitusNCT01681147
Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
A study testing 2 online nutrition and exercise education classes and Self monitoring of blood glucose levels in people with Gestational Diabetes Mellitus, run by Joslin Diabetes Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- 2 online nutrition and exercise education classes and Self monitoring of blood glucose levels
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram 2 hour OGTT
- BMI >40
- Multiple gestation (i.e., twins, triplets, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- 2 online nutrition and exercise education classes, Self monitoring of blood glucose levels
- Keywords
- Gestational Diabetes, postpartum, nutrition, exercise
- Medical subject headings
- Diabetes, Gestational, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 online nutrition and exercise education classesBehavioural
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 levelsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Standard postpartum care after a pregnancy with gestational diabetes |
| Standard Care+Education Classes | Experimental | Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes Receives: Behavioral: 2 online nutrition and exercise education classes |
| Standard Care+Education Classes+Glucose Monitoring | Experimental | Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels Receives: Behavioral: 2 online nutrition and exercise education classes; Behavioral: Self monitoring of blood glucose levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
- 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.
Measured: 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.
Measured: 1 year postpartum
Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
- 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.
Measured: Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months, 9 months, all reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJun 2012
- Primary completion20 Jan 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Florence Brown, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681147
- Sponsor's protocol ID
- CHS 2012-16
- Status last verified
- Jul 2022
- First submitted
- 4 Sep 2012
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01681147
- Acronym / sponsor ID
- CHS 2012-16
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational Diabetes, postpartum, nutrition, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- Jun 2012 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 7 Sep 2012 (estimated)
- Results
- Posted 12 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Standard postpartum care after a pregnancy with gestational diabetes |
| Standard Care+Education Classes | Experimental | Behavioral: 2 online nutrition and exercise education classesStandard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes |
| Standard Care+Education Classes+Glucose Monitoring | Experimental | Behavioral: 2 online nutrition and exercise education classes, Behavioral: Self monitoring of blood glucose levelsStandard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes Self monitoring of blood glucose levels |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram 2 hour OGTT
- BMI >40
- Multiple gestation (i.e., twins, triplets, etc.)
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 |
|---|---|---|
| 2 online nutrition and exercise education classesTwo 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 | Behavioural | Standard Care+Education Classes, Standard Care+Education Classes+Glucose Monitoring |
| Self monitoring of blood glucose levelsSelf 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 | Behavioural | Standard Care+Education Classes+Glucose Monitoring |
Primary outcome
Weight Loss
Time frame: 1 year postpartum
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
Time frame: 1 year postpartum
1. Adherence to diabetes screening using the 75 gram 2 hour oral glucose tolerance test (OGTT) or fasting blood glucose at 12 months (+/- 3 months). 2. 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
Time frame: Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported
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.
3 secondary outcomes
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Time frame: 3 months, 6 months, 9 months, all reported
Food Frequency Questionnaire
Time frame: 3 months, 6 months, 9 months, all reported
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Time frame: 3 months, 6 months, 9 months, all reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Florence Brown, MD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 online nutrition and exercise education classes and Self monitoring of blood glucose levels in people with Gestational Diabetes Mellitus, run by Joslin Diabetes Center at 1 site in United States.
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 5 inclusion and 3 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 12 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Loss (time frame: 1 year postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2023.