Gestational DiabetesSWEETNCT04583839
SWEET: Postpartum Navigation After GDM
A study testing Patient Navigation Program in people with Gestational Diabetes and Preventive Care / Anticipatory Guidance, run by Northwestern University at 1 site in United States.
Trial summary
This study is a pilot assessment of Sustaining Women's Engagement and Enabling Transitions after GDM (SWEET), a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with gestational diabetes mellitus. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Preventive Care / Anticipatory Guidance, Retention in Care
- What is being tested?
- Patient Navigation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnancy delivering at or after 30 weeks of gestation, regardless of neonatal outcome
- Gestational diabetes mellitus, treatment of any modality
- English- or Spanish- speaker
- Age 16 or greater
- Established patient at the Northwestern Medicine obstetrics and gynecology practices
- Age 18 or greater
- English-speaking
- Obstetrician or advanced practitioner who has provided postpartum care to a participating SWEET participant OR primary care provider who has provided primary care to a participating SWEET participant
Who cannot join
- Intent to transfer prenatal care to an outside institution or leave Chicago region
- Pre-gestational diabetes mellitus
- Weight loss during pregnancy
- History of bariatric surgery
- Prior enrollment in SWEET
- Enrollment in a concurrent research study that poses a potential conflict to the aims of SWEET or the other study
- Health care provider participants:
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: SWEET: Sustaining Women's Engagement and Enabling Transitions After Gestational Diabetes Mellitus
This study is a pilot assessment of Sustaining Women's Engagement and Enabling Transitions after GDM (SWEET), a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with gestational diabetes mellitus. The investigators aim to determine, via a randomized controlled trial of 40 women who have had GDM, whether those who receive the navigation intervention have improved diabetes-related health at 1 year after birth compared to those who receive usual care. The SWEET intervention will provide GDM-specific, individualized navigation services that leverage existing clinical infrastructure, including logistical support, psychosocial support, and health education, through 1-year postpartum. Participants will undergo surveys, interviews, and medical record review at multiple time points. The investigators will also conduct qualitative interviews with clinical providers.
Read the detailed description
Gestational diabetes mellitus (GDM) poses a substantial long-term health burden to women due to the 7-fold increased risk of developing type 2 diabetes mellitus (T2DM) and other cardiovascular disorders. Yet, there are many gaps in the transition period after GDM, which is a particularly critical time due to enhanced motivation and access. Nevertheless, a minority of women receive postpartum screening for dysglycemia or have successful transition to primary care. Although T2DM prevention interventions can be successful, they cannot be deployed without retention and engagement in care. Addressing the unique barriers experienced by postpartum women requires innovative models of health care delivery to promote prevention of T2DM after GDM. One potential intervention with demonstrated successes in other arenas is patient navigation, a barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services.
This protocol is to perform a pilot assessment of Sustaining Women's Engagement and Enabling Transitions after GDM (SWEET), a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with GDM. The investigators aim to determine, via a randomized controlled trial of 40 women who have had GDM, whether those who receive the SWEET navigation intervention have improved diabetes-related health at 1 year after birth compared to those who receive usual care. In order to promote self-efficacy, enhance access, and sustain long-term engagement, the SWEET intervention will provide GDM-specific, individualized navigation services that leverage existing clinical infrastructure, including logistical support, psychosocial support, and health education, through 1-year postpartum.
Aim 1 will evaluate whether clinical (weight, glycemic control, abdominal circumference, and blood pressure), health services (postpartum and primary care visit attendance), and patient-reported (diabetes self-efficacy, activation, and T2DM risk perception) outcomes differ in women exposed to SWEET versus usual care. Aim 2 will evaluate feasibility and acceptability. This proposal will generate key data for the conduct of a full-scale trial of a GDM-specific postpartum patient navigation program that will address critical questions about long-term maternal health and T2DM prevention.
SWEET bridges the chasm between care during pregnancy - focused on improving the health of the pregnant woman and her offspring - and long-term women's health care - focused on chronic disease management and preventive health. The long-term goals are to understand how to optimize long-term health after GDM in order to prevent or ameliorate the effects of T2DM beyond the perinatal period.
- Conditions
- Gestational Diabetes, Preventive Care / Anticipatory Guidance, Retention in Care, Postpartum Health, Lifestyle Modification
- Being tested
- Patient Navigation Program
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigation ProgramBehavioural
Also called SWEET
SWEET is a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with GDM. Women in SWEET will receive GDM-specific, tapered, individualized navigation services, including logistical support, psychosocial support, and patient education, through 1-year postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Navigation Group | Experimental | Women who are randomized into SWEET will be assigned to a patient navigator. The navigator will meet women during hospitalization, at postpartum appointments, during primary care appointments, and as needed. At these face-to-face meetings, the navigator will perform education about the postpartum OGTT, post-GDM management plan, diabetes mellitus risks, lifestyle modification, and primary care transition. The navigator will facilitate the development of an individualized GDM Care Plan in conjunction with the patient and the medical team. The navigator will assess individual barriers to T2DM screening and prevention. At appointments, the navigator will also ensure a woman understands her diabetes-related care plan and will perform health education and barrier-reducing tasks as needed. Receives: Behavioral: Patient Navigation Program |
| Non-navigation cohort | No intervention | No navigation will be provided; women will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum weight retention
Difference between 1) preconception weight and 2) weight at 1 year postpartum,
Measured: 1 year postpartum
Secondary outcomes (10)
Postpartum diabetes screening completion
Number of women with completion of a 2-hour oral glucose tolerance test by 12 weeks postpartum.
Measured: 4-12 weeks postpartum
Postpartum diabetes screening result
Result of postpartum OGTT.
Measured: 4-12 weeks postpartum
Abdominal circumference
Abdominal circumference at any time point in the first year after giving birth.
Measured: 4-12 weeks and 1 year postpartum
Blood pressure
Blood pressure at any time point in the first year after giving birth and proportion with hypertension.
Measured: 4-12 weeks and 1 year postpartum
Postpartum visit attendance
Attendance at a comprehensive postpartum care visit by 12 weeks postpartum.
Measured: 4-12 weeks postpartum
Assessment of postpartum glycemic control
Number of women who complete any measure of glycemic control (fasting glucose, random glucose, and/or hemoglobin A1c) by 1 year postpartum.
Measured: 1 year postpartum
Postpartum transition to primary care
Number of women with appointment made and kept for primary care by 1 year postpartum.
Measured: 1 year postpartum
Diabetes self-efficacy
Diabetes Empowerment Scale (DES)- Minimum score is 1, and maximum score is 5. Higher scores indicate greater levels of diabetes self-efficacy.
Measured: 4-12 weeks and 1 year postpartum
Patient activation
Patient Activation Measure (PAM)- Patient knowledge, skill, and confidence for managing one's own health and healthcare. Minimum score is 1, and maximum score is 100. Higher scores indicate higher activation levels in self-management.
Measured: 4-12 weeks and 1 year postpartum
Diabetes risk perception
Risk Perception Survey for Developing Diabetes (RPS-DD)- adapted for women with gestational diabetes- Scores are averaged with higher scores indicating a greater personal control to prevent development of DM. Minimum score of 1, and maximum score of 5. Higher scores indicate greater personal control beliefs.
Measured: 4-12 weeks and 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Dec 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two cohorts. One cohort will be provided intensive, individualized patient navigation services through one year postpartum, with a focus on diabetes prevention. The second cohort will receive usual care.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynn M Yee, Northwestern University
- Investigators
- Lynn M Yee, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583839
- Sponsor's protocol ID
- STU00212306
- Other IDs
- 1R34DK125958
- Acronym
- SWEET
- Status last verified
- Jun 2024
- First submitted
- 29 Sep 2020
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWEET: Sustaining Women's Engagement and Enabling Transitions After Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04583839
- Acronym / sponsor ID
- SWEET / STU00212306
- Conditions
- Gestational Diabetes, Preventive Care / Anticipatory Guidance, Retention in Care, Postpartum Health, Lifestyle Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot assessment of Sustaining Women's Engagement and Enabling Transitions after GDM (SWEET), a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with gestational diabetes mellitus. The investigators aim to determine, via a randomized controlled trial of 40 women who have had GDM, whether those who receive the navigation intervention have improved diabetes-related health at 1 year after birth compared to those who receive usual care. The SWEET intervention will provide GDM-specific, individualized navigation services that leverage existing clinical infrastructure, including logistical support, psychosocial support, and health education, through 1-year postpartum. Participants will undergo surveys, interviews, and medical record review at multiple time points. The investigators will also conduct qualitative interviews with clinical providers.
Detailed description
Gestational diabetes mellitus (GDM) poses a substantial long-term health burden to women due to the 7-fold increased risk of developing type 2 diabetes mellitus (T2DM) and other cardiovascular disorders. Yet, there are many gaps in the transition period after GDM, which is a particularly critical time due to enhanced motivation and access. Nevertheless, a minority of women receive postpartum screening for dysglycemia or have successful transition to primary care. Although T2DM prevention interventions can be successful, they cannot be deployed without retention and engagement in care. Addressing the unique barriers experienced by postpartum women requires innovative models of health care delivery to promote prevention of T2DM after GDM. One potential intervention with demonstrated successes in other arenas is patient navigation, a barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services.
This protocol is to perform a pilot assessment of Sustaining Women's Engagement and Enabling Transitions after GDM (SWEET), a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with GDM. The investigators aim to determine, via a randomized controlled trial of 40 women who have had GDM, whether those who receive the SWEET navigation intervention have improved diabetes-related health at 1 year after birth compared to those who receive usual care. In order to promote self-efficacy, enhance access, and sustain long-term engagement, the SWEET intervention will provide GDM-specific, individualized navigation services that leverage existing clinical infrastructure, including logistical support, psychosocial support, and health education, through 1-year postpartum.
Aim 1 will evaluate whether clinical (weight, glycemic control, abdominal circumference, and blood pressure), health services (postpartum and primary care visit attendance), and patient-reported (diabetes self-efficacy, activation, and T2DM risk perception) outcomes differ in women exposed to SWEET versus usual care. Aim 2 will evaluate feasibility and acceptability. This proposal will generate key data for the conduct of a full-scale trial of a GDM-specific postpartum patient navigation program that will address critical questions about long-term maternal health and T2DM prevention.
SWEET bridges the chasm between care during pregnancy - focused on improving the health of the pregnant woman and her offspring - and long-term women's health care - focused on chronic disease management and preventive health. The long-term goals are to understand how to optimize long-term health after GDM in order to prevent or ameliorate the effects of T2DM beyond the perinatal period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two cohorts. One cohort will be provided intensive, individualized patient navigation services through one year postpartum, with a focus on diabetes prevention. The second cohort will receive usual care.
| Arm | Type | Receives |
|---|---|---|
| Navigation Group | Experimental | Behavioral: Patient Navigation ProgramWomen who are randomized into SWEET will be assigned to a patient navigator. The navigator will meet women during hospitalization, at postpartum appointments, during primary care appointments, and as needed. At these face-to-face meetings, the navigator will perform education about the postpartum OGTT, post-GDM management plan, diabetes mellitus risks, lifestyle modification, and primary care transition. The navigator will facilitate the development of an individualized GDM Care Plan in conjunction with the patient and the medical team. The navigator will assess individual barriers to T2DM screening and prevention. At appointments, the navigator will also ensure a woman understands her diabetes-related care plan and will perform health education and barrier-reducing tasks as needed. |
| Non-navigation cohort | No intervention | –No navigation will be provided; women will receive usual care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnancy delivering at or after 30 weeks of gestation, regardless of neonatal outcome
- Gestational diabetes mellitus, treatment of any modality
- English- or Spanish- speaker
- Age 16 or greater
- Established patient at the Northwestern Medicine obstetrics and gynecology practices
Key exclusion criteria (7 listed)
- Intent to transfer prenatal care to an outside institution or leave Chicago region
- Pre-gestational diabetes mellitus
- Weight loss during pregnancy
- History of bariatric surgery
- Prior enrollment in SWEET
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 |
|---|---|---|
| Patient Navigation ProgramAlso: SWEETSWEET is a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with GDM. Women in SWEET will receive GDM-specific, tapered, individualized navigation services, including logistical support, psychosocial support, and patient education, through 1-year postpartum. | Behavioural | Navigation Group |
Primary outcome
Postpartum weight retention
Time frame: 1 year postpartum
Difference between 1) preconception weight and 2) weight at 1 year postpartum,
10 secondary outcomes
Postpartum diabetes screening completion
Time frame: 4-12 weeks postpartum
Postpartum diabetes screening result
Time frame: 4-12 weeks postpartum
Abdominal circumference
Time frame: 4-12 weeks and 1 year postpartum
Blood pressure
Time frame: 4-12 weeks and 1 year postpartum
Postpartum visit attendance
Time frame: 4-12 weeks postpartum
Assessment of postpartum glycemic control
Time frame: 1 year postpartum
Postpartum transition to primary care
Time frame: 1 year postpartum
Diabetes self-efficacy
Time frame: 4-12 weeks and 1 year postpartum
Patient activation
Time frame: 4-12 weeks and 1 year postpartum
Diabetes risk perception
Time frame: 4-12 weeks and 1 year postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Lynn M Yee, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation Program in people with Gestational Diabetes and Preventive Care / Anticipatory Guidance, run by Northwestern University 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 8 inclusion and 7 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 6 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postpartum weight retention (time frame: 1 year postpartum). 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 6 Jun 2024.