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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
NCT02744300 |
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Date of registration:
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03/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Balance After Baby Intervention for Women With Recent Gestational Diabetes
BABI2 |
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Scientific title:
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Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02744300 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Jacinda Nicklas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Name:
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Ellen W Seely, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Gestational Diabetes Mellitus
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Intervention(s)
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Behavioral: BABI-2 Lifestyle Intervention
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Primary Outcome(s)
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Weight loss
[Time Frame: 12 months after delivery]
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Secondary Outcome(s)
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Weight loss
[Time Frame: 24 months after delivery]
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Number of participants with a fasting glucose level greater than 100 mg/dL
[Time Frame: 6 months and 18 months postpartum]
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Diabetes
[Time Frame: 6 weeks, 12 months, and 24 months after delivery]
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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]
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Secondary ID(s)
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6201.25-S01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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