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CompletedNCT01858233IBEPUpdated Dec 4, 2015

The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes

An interventional study of Intensive Behavioral Modification in Gestational Diabetes, Weight Gain During Pregnancy and Weight Loss After Pregnancy, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-12-04.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The IBEP study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. The primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (IBEP) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.

02

Conditions studied

  • Gestational Diabetes
  • Weight Gain During Pregnancy
  • Weight Loss After Pregnancy

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Keywords

  • Gestational diabetes
03

In context

Diabetes, Gestational

857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.

This study's enrollment of 110 is close to the median of 110 across 560 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women diagnosed with gestational diabetes between 20 and 34 weeks gestation

Exclusion criteria

Exclusion Criteria:

  • women on chronic steroid therapy
  • women with a diagnosis of GDM \<20 weeks or >34 weeks
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Intensive Behavioral Modification

    intensive dietary counseling, increased activity, lactation consult

    Behavioral: Intensive Behavioral Modification

  • No intervention
    Routine care

    standard dietary counseling

Interventions

  • BehavioralIntensive Behavioral Modification

    Intensive dietary counseling, increased physical activity, lactation counseling

06

What researchers measure

Primary outcomes

  1. The IBEP Study

    To evaluate mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks in women enrolled in an intensive behavioral educational program compared to women with GDM who undergo routine GDM education and counseling.

    Time frame: 2 years

Secondary outcomes

  1. The IBEP Study

    To evaluate the amount of weight lost in women enrolled in an intensive behavioral program and whether it correlates with more favorable lipid profiles at 6 weeks postpartum.

    Time frame: 2 years

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Publications

  • Durnwald CP, Kallan MJ, Allison KC, Sammel MD, Wisch S, Elovitz M, Parry S. A Randomized Clinical Trial of an Intensive Behavior Education Program in Gestational Diabetes Mellitus Women Designed to Improve Glucose Levels on the 2-Hour Oral Glucose Tolerance Test. Am J Perinatol. 2016 Oct;33(12):1145-51. doi: 10.1055/s-0036-1585085. Epub 2016 Jul 11. PubMed 27398697 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Sep 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2013
First posted
May 21, 2013
Start
Nov 2012
Primary completionActual
Sep 2015
CompletionActual
Dec 2015
Last update
Dec 4, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01858233
Responsible party
Sponsor
First posted
May 21, 2013
Start date
Nov 2012
Primary completion
Sep 2015
Completion
Dec 2015
Last update
Dec 4, 2015

Study contacts

Celeste Durnwald, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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