Back to resultsLifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance (APPLES)
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes focused on measuring Gestational Diabetes, Weight Loss, Physical Activity, Pregnancy, Postpartum, Intervention
Eligibility 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
Sites / Locations
- Division of Research Northern California
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Counseling
Control
Arm Description
Outcomes
Primary Outcome Measures
postpartum body weight
Secondary Outcome Measures
the proportion of women who reach body weight goals
percent of calories from fat
time spent in physical activity (PA) by intensity
postpartum glycemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01489163
Brief Title
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance
Acronym
APPLES
Official Title
Translational Diabetes Prevention in GDM
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Gestational Diabetes, Weight Loss, Physical Activity, Pregnancy, Postpartum, Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Counseling
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
postpartum body weight
Time Frame
through 24 months postpartum
Secondary Outcome Measure Information:
Title
the proportion of women who reach body weight goals
Time Frame
through 24 months postpartum
Title
percent of calories from fat
Time Frame
through 24 months postpartum
Title
time spent in physical activity (PA) by intensity
Time Frame
through 24 months postpartum
Title
postpartum glycemia
Time Frame
through 24 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assiamira Ferrara, MD, PhD
Organizational Affiliation
Kaiser Permanente Division of Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Research Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance
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