Balance After Baby Intervention for Women With Recent Gestational Diabetes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/19/2019 |
| Start Date: | September 2016 |
| End Date: | September 2019 |
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.
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.
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.
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.
Inclusion Criteria:
- 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)
- Daily access to the internet
- English or Spanish speaking
- Capable of providing informed consent
Exclusion Criteria:
- 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
- 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
We found this trial at
1
site
Denver, Colorado 80291
Principal Investigator: Jacinda Nicklas, MD, MPH, MA
Phone: 303-724-8998
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