Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance (APPLES)

February 1, 2019 updated by: Kaiser Permanente

Translational Diabetes Prevention in GDM

The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Division of Research Northern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
  • Pregnancy complicated by high glucose levels starting November 2011

Exclusion Criteria:

  • Recognized DM prior to pregnancy
  • Uncontrolled hypertension during pregnancy
  • Severe active thyroid disease during pregnancy
  • Severe diseases of the cardio-pulmonary system
  • Diagnosis of a severe psychiatric disorder
  • Diagnosis of cancer
  • Conditions that lead to diet changes
  • Addiction to alcohol or illegal drugs
  • Current corticosteroid medicine use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Lifestyle Counseling
Behavioral: Lifestyle Counseling
The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postpartum body weight
Time Frame: through 24 months postpartum
through 24 months postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
the proportion of women who reach body weight goals
Time Frame: through 24 months postpartum
through 24 months postpartum
percent of calories from fat
Time Frame: through 24 months postpartum
through 24 months postpartum
time spent in physical activity (PA) by intensity
Time Frame: through 24 months postpartum
through 24 months postpartum
postpartum glycemia
Time Frame: through 24 months postpartum
through 24 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Assiamira Ferrara, MD, PhD, Kaiser Permanente Division of Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 7, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (Estimate)

December 9, 2011

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN-03AFerr-02-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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