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NCT01158131 · ClinicalTrials.gov registry record · Phase 2

Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)

A Phase 2 study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target

NCT01158131: Completed Phase 2 study, sponsored by Brigham and Women's Hospital.

NCT01158131 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01158131, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing diabetes later in life. The purpose of the study is to test whether 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, incorporating advice about diet and physical activity, delivered in the first 12 months after delivery will help women lose weight, improve overall health, and decrease their risk factors for type 2 diabetes.

Primary Outcome

Postpartum weight loss for all subjects will be assessed.

Interventions

  • BEHAVIORAL Balance after Baby Lifestyle Intervention Program

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2009-11
Est. Completion 2012-09
Phase Phase 2
Brigham and Women's Hospital

937 total trials

What the finished NCT01158131 record still lists

NCT01158131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 1 intervention - of which Balance after Baby Lifestyle Intervention Program is the first listed.

NCT01158131 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01158131 about?

NCT01158131 is a clinical study titled "Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)". Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing diabetes later in life. The purpose of the study is to test whether a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP...

What is the current status of trial NCT01158131?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2009-11. Estimated completion is 2012-09.

What interventions are being tested in trial NCT01158131?

The interventions under investigation include: Balance after Baby Lifestyle Intervention Program (BEHAVIORAL).

Who is sponsoring clinical trial NCT01158131?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01158131's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01158131, the US trial registry maintained by the National Library of Medicine. NCT01158131 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.