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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01489163
First Posted: December 9, 2011
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaiser Permanente
December 7, 2011
December 9, 2011
August 1, 2017
December 2011
October 2015   (Final data collection date for primary outcome measure)
postpartum body weight [ Time Frame: through 24 months postpartum ]
Same as current
Complete list of historical versions of study NCT01489163 on ClinicalTrials.gov Archive Site
  • the proportion of women who reach body weight goals [ Time Frame: through 24 months postpartum ]
  • percent of calories from fat [ Time Frame: through 24 months postpartum ]
  • time spent in physical activity (PA) by intensity [ Time Frame: through 24 months postpartum ]
  • postpartum glycemia [ Time Frame: through 24 months postpartum ]
Same as current
Not Provided
Not Provided
 
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Gestational Diabetes
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.
  • Experimental: Lifestyle Counseling
    Intervention: Behavioral: Lifestyle Counseling
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
350
December 2017
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
20 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01489163
CN-03AFerr-02-H
No
Not Provided
Not Provided
Kaiser Permanente
Kaiser Permanente
Not Provided
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente Division of Research
Kaiser Permanente
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP