Text Size

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

This study is currently recruiting participants.
Verified April 2013 by Kaiser Permanente
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01489163
First received: December 7, 2011
Last updated: April 17, 2013
Last verified: April 2013
History of Changes

December 7, 2011
April 17, 2013
December 2011
June 2016   (final data collection date for primary outcome measure)
postpartum body weight [ Time Frame: through 24 months postpartum ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • percent of calories from fat [ Time Frame: through 24 months postpartum ] [ Designated as safety issue: No ]
  • time spent in physical activity (PA) by intensity [ Time Frame: through 24 months postpartum ] [ Designated as safety issue: No ]
  • postpartum glycemia [ Time Frame: through 24 months postpartum ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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.
 
Recruiting
350
Not Provided
June 2016   (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
Female
20 Years to 45 Years
No
Contact: Assiamira Ferrara, MD, PhD 510-891-3588 assiamira.ferrara@kp.org
Contact: Samantha F Ehrlich, MPH, PhD 510-891-3505 samantha.ehrlich@kp.org
United States
 
NCT01489163
CN-03AFerr-02-H
No
Kaiser Permanente
Kaiser Permanente
Not Provided
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente Division of Research
Kaiser Permanente
April 2013

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