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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01489163
First received: December 7, 2011
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Gestational Diabetes
Behavioral: Lifestyle Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Translational Diabetes Prevention in GDM

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • postpartum body weight [ Time Frame: through 24 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: December 2011
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489163

Locations
United States, California
Division of Research Northern California
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente Division of Research
  More Information

Additional Information:
No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01489163     History of Changes
Other Study ID Numbers: CN-03AFerr-02-H
Study First Received: December 7, 2011
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Gestational Diabetes
Weight Loss
Physical Activity
Pregnancy
Postpartum
Intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Hyperglycemia

ClinicalTrials.gov processed this record on July 28, 2014