Gestational Diabetes MellitusBABI2NCT02744300
Balance After Baby Intervention for Women With Recent Gestational Diabetes
A study testing BABI-2 Lifestyle Intervention in people with Gestational Diabetes Mellitus, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes later in life. In our 2012 pilot study we created and tested a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- BABI-2 Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 29 Jul 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy female with a diagnosis of gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (see below) in most recent singleton or twin pregnancy (Carpenter \& Coustan, 1982)
- Women with a glucose value ≥200 mg/dL after a 50-g glucose challenge test at >12 weeks' gestation will also be included
- 18 years of age or older
- No personal history of Type 1 or 2 diabetes
- Pre-pregnancy body mass index between 18 and 50 kg/m2
- Six weeks postpartum body mass index between 24 and 50 kg/m2 (>22 for Asians)
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- Daily access to the internet
- English or Spanish speaking
- Capable of providing informed consent
Who cannot join
- Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
- Current pregnancy
- Premature delivery < 34 weeks gestation
- Diagnosis of diseases associated with glucose metabolism
- Current or planned participation in a commercial weight loss program (i.e. Jenny Craig) over the duration of the study
- Taking certain prescription medications including high dose glucocorticoids, atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.), or other prescription weight loss medications
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- Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer
- Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months
- Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
- Other active medical problems detected by examination or laboratory testing
- Plans to be in a different geographic area within the next 6 months
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Denver, Colorado, 80202
About this study
Official title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus
Women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes later in life. In our 2012 pilot study we created and tested a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with a recent history of GDM. This program, delivered in the first year postpartum, encouraged weight loss, dietary changes, and physical activity. The purpose of the current study, called Balance After Baby Intervention 2 (BABI-2), is to study a larger group of women with two years of follow-up. We will assess whether women assigned to the intervention group lose more weight and decrease their risk factors for type 2 diabetes.
Participants assigned to the BAB lifestyle intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips.
Participants assigned to the post-GDM follow-up group will have access to a website containing links to information about diabetes prevention.
Read the detailed description
The landmark Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes. These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender. However, the DPP does not have a specific focus on new mothers with a recent history of gestational diabetes. Although there are recommendations that all women with gestational diabetes mellitus (GDM) receive postpartum testing for diabetes and type 2 diabetes risk reduction, study findings suggest that women with a recent history of GDM may be unaware of their risk for future diabetes, and also do not take steps to reduce their risks.
The postpartum period is also a time when many changes occur in a woman's life, with competing responsibilities often altering sleep patterns, work schedules, eating patterns, exercise regularity, and time allocation. New mothers may have difficulty engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care. In response to the barriers identified in literature and gleaned from the focus groups and informant interviews of a preliminary study (2009p000042), we created a lifestyle/behavioral intervention that utilizes a modified DPP.
In 2012 we completed a one year pilot study (2009p002118) to assess the feasibility and effectiveness of the lifestyle/behavioral intervention. The pilot study demonstrated that women in the intervention group lost more weight and were closer to pre-pregnancy weight that the control group.
Our goals in Phase 2 of the study are: to gather more data about the effects of the intervention at 12 months; to determine if the greater weight loss observed in the pilot intervention arm at 12 months can be replicated with a larger number of women and maintained at 24 months; and to see whether there is a significant effect on glucose tolerance in the intervention arm at 24 months.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- BABI-2 Lifestyle Intervention
- Keywords
- Gestational diabetes mellitus (GDM) in most recent pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BABI-2 Lifestyle InterventionBehavioural
Also called Balance After Baby 2 Lifestyle Intervention Program
Participants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips.
| Study group | Role | What they receive |
|---|---|---|
| BABI-2 Lifestyle Intervention | Experimental | Participants in this group will take part in the web-based lifestyle intervention which includes access to the lifestyle intervention website and personalized coaching from a Lifestyle Coach. Receives: Behavioral: BABI-2 Lifestyle Intervention |
| Post-GDM Follow-up Group | No intervention | Participants in this group will have access to a separate website containing links to information about diabetes prevention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Postpartum weight loss will be measured from 6 weeks postpartum to 12 months postpartum.
Measured: 12 months after delivery
Secondary outcomes (4)
Weight loss
Postpartum weight loss will be measured from 6 weeks postpartum to 24 months postpartum
Measured: 24 months after delivery
Diabetes
Risk factors or diagnosis of diabetes will be assessed in all participants via oral glucose tolerance tests (OGTTs) and by measuring glycated hemoglobin (HbA1c).
Measured: 6 weeks, 12 months, and 24 months after delivery
Number of participants with a fasting glucose level greater than 100 mg/dL
Measured: 6 months and 18 months postpartum
Number of participants with either: a HbA1c value greater than or equal to 5.7; or a 2 hour value on a 75 g oral glucose tolerance test of greater than or equal to 140
Measured: 6 weeks, 12 months, and 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startSep 2016
- Primary completion29 Jul 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Ellen W. Seely, Brigham and Women's Hospital
- Investigators
- Ellen W Seely, MD, Principal investigator, Brigham and Women's HospitalJacinda Nicklas, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744300
- Sponsor's protocol ID
- 6201.25-S01
- Acronym
- BABI2
- Status last verified
- Jul 2021
- First submitted
- 3 Mar 2016
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
PubMed 7148898Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527Kim SY, England L, Wilson HG, Bish C, Satten GA, Dietz P. Percentage of gestational diabetes mellitus attributable to overweight and obesity. Am J Public Health. 2010 Jun;100(6):1047-52. doi: 10.2105/AJPH.2009.172890. Epub 2010 Apr 15.
PubMed 20395581Swan W, Kilmartin G, Liaw ST. Assessment of readiness to prevent type 2 diabetes in a population of rural women with a history of gestational diabetes. Rural Remote Health. 2007 Oct-Dec;7(4):802. Epub 2007 Nov 19.
PubMed 18020897Walker LO, Grobe SJ. The construct of thriving in pregnancy and postpartum. Nurs Sci Q. 1999 Apr;12(2):151-7. doi: 10.1177/089431849901200216.
PubMed 11847682Nicklas JM, Zera CA, England LJ, Rosner BA, Horton E, Levkoff SE, Seely EW. A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2014 Sep;124(3):563-570. doi: 10.1097/AOG.0000000000000420.
PubMed 25162257Rosenberg EA, Seely EW, James K, Soffer MD, Nelson S, Nicklas JM, Powe CE. Carbohydrate Intake and Oral Glucose Tolerance Test Results in the Postpartum Period. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1007-e1012. doi: 10.1210/clinem/dgad234.
PubMed 37097924
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02744300
- Acronym / sponsor ID
- BABI2 / 6201.25-S01
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational diabetes mellitus (GDM) in most recent pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- Sep 2016 (actual)
- Primary completion
- 29 Jul 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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.
Women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes later in life. In our 2012 pilot study we created and tested a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with a recent history of GDM. This program, delivered in the first year postpartum, encouraged weight loss, dietary changes, and physical activity. The purpose of the current study, called Balance After Baby Intervention 2 (BABI-2), is to study a larger group of women with two years of follow-up. We will assess whether women assigned to the intervention group lose more weight and decrease their risk factors for type 2 diabetes.
Participants assigned to the BAB lifestyle intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips.
Participants assigned to the post-GDM follow-up group will have access to a website containing links to information about diabetes prevention.
Detailed description
The landmark Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes. These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender. However, the DPP does not have a specific focus on new mothers with a recent history of gestational diabetes. Although there are recommendations that all women with gestational diabetes mellitus (GDM) receive postpartum testing for diabetes and type 2 diabetes risk reduction, study findings suggest that women with a recent history of GDM may be unaware of their risk for future diabetes, and also do not take steps to reduce their risks.
The postpartum period is also a time when many changes occur in a woman's life, with competing responsibilities often altering sleep patterns, work schedules, eating patterns, exercise regularity, and time allocation. New mothers may have difficulty engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care. In response to the barriers identified in literature and gleaned from the focus groups and informant interviews of a preliminary study (2009p000042), we created a lifestyle/behavioral intervention that utilizes a modified DPP.
In 2012 we completed a one year pilot study (2009p002118) to assess the feasibility and effectiveness of the lifestyle/behavioral intervention. The pilot study demonstrated that women in the intervention group lost more weight and were closer to pre-pregnancy weight that the control group.
Our goals in Phase 2 of the study are: to gather more data about the effects of the intervention at 12 months; to determine if the greater weight loss observed in the pilot intervention arm at 12 months can be replicated with a larger number of women and maintained at 24 months; and to see whether there is a significant effect on glucose tolerance in the intervention arm at 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BABI-2 Lifestyle Intervention | Experimental | Behavioral: BABI-2 Lifestyle InterventionParticipants in this group will take part in the web-based lifestyle intervention which includes access to the lifestyle intervention website and personalized coaching from a Lifestyle Coach. |
| Post-GDM Follow-up Group | No intervention | –Participants in this group will have access to a separate website containing links to information about diabetes prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy female with a diagnosis of gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (see below) in most recent singleton or twin pregnancy (Carpenter \& Coustan, 1982)
- Women with a glucose value ≥200 mg/dL after a 50-g glucose challenge test at >12 weeks' gestation will also be included
- 18 years of age or older
- No personal history of Type 1 or 2 diabetes
- Pre-pregnancy body mass index between 18 and 50 kg/m2
Key exclusion criteria (12 listed)
- Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
- Current pregnancy
- Premature delivery < 34 weeks gestation
- Diagnosis of diseases associated with glucose metabolism
- Current or planned participation in a commercial weight loss program (i.e. Jenny Craig) over the duration of the study
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 |
|---|---|---|
| BABI-2 Lifestyle InterventionAlso: Balance After Baby 2 Lifestyle Intervention ProgramParticipants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips. | Behavioural | BABI-2 Lifestyle Intervention |
Primary outcome
Weight loss
Time frame: 12 months after delivery
Postpartum weight loss will be measured from 6 weeks postpartum to 12 months postpartum.
4 secondary outcomes
Weight loss
Time frame: 24 months after delivery
Diabetes
Time frame: 6 weeks, 12 months, and 24 months after delivery
Number of participants with a fasting glucose level greater than 100 mg/dL
Time frame: 6 months and 18 months postpartum
Number of participants with either: a HbA1c value greater than or equal to 5.7; or a 2 hour value on a 75 g oral glucose tolerance test of greater than or equal to 140
Time frame: 6 weeks, 12 months, and 24 months 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 21 Jul 2021.
- Background: PubMed 7148898Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
- Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Background: PubMed 20395581Kim SY, England L, Wilson HG, Bish C, Satten GA, Dietz P. Percentage of gestational diabetes mellitus attributable to overweight and obesity. Am J Public Health. 2010 Jun;100(6):1047-52. doi: 10.2105/AJPH.2009.172890. Epub 2010 Apr 15.
- Background: PubMed 18020897Swan W, Kilmartin G, Liaw ST. Assessment of readiness to prevent type 2 diabetes in a population of rural women with a history of gestational diabetes. Rural Remote Health. 2007 Oct-Dec;7(4):802. Epub 2007 Nov 19.
- Background: PubMed 11847682Walker LO, Grobe SJ. The construct of thriving in pregnancy and postpartum. Nurs Sci Q. 1999 Apr;12(2):151-7. doi: 10.1177/089431849901200216.
- Background: PubMed 25162257Nicklas JM, Zera CA, England LJ, Rosner BA, Horton E, Levkoff SE, Seely EW. A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2014 Sep;124(3):563-570. doi: 10.1097/AOG.0000000000000420.
- Derived from this study: PubMed 37097924Rosenberg EA, Seely EW, James K, Soffer MD, Nelson S, Nicklas JM, Powe CE. Carbohydrate Intake and Oral Glucose Tolerance Test Results in the Postpartum Period. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1007-e1012. doi: 10.1210/clinem/dgad234.
- 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.
Ellen W Seely, MD principal investigator
Brigham and Women's Hospital
Jacinda Nicklas, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BABI-2 Lifestyle Intervention in people with Gestational Diabetes Mellitus, run by Brigham and Women's Hospital 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 9 inclusion and 12 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 21 Jul 2021. 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?
Weight loss (time frame: 12 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744300, which also lists 7 linked publications.
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 21 Jul 2021.