Back to resultsA Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)
Lifestyle education (English & Spanish)
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes focused on measuring Recurring Gestational Diabetes, Prevention
Eligibility Criteria
Inclusion Criteria:
- GDM in last pregnancy
- BMI 30-40
- Age 18-40
- 1-5 years since last pregnancy
- Non-smoking
- English or Spanish speaking
- Planning to have a baby but willing to use birth control during the 3 month weight loss program
Exclusion Criteria:
- 3 or more miscarriages
- History of infertility
- Type 1 or Type 2 diabetes
- Any weight loss since last pregnancy (based on last pre-pregnancy weight)
- History of major psychiatric illness, drug abuse, or unsafe dieting practices
- History of bariatric surgery, major medical conditions that prohibit physical activity or dietary intervention (MD consent may be required)
Sites / Locations
- Sierra Vista Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Intervention Group-English
Intervention Group-Spanish
Lifestyle education-English
Lifestyle education-Spanish
Arm Description
Intervention Group will be learning how to lose weight through healthy eating and moderate exercise. The goal is to get participants to lose 7% of body weight and increase physical activity to 2 1/2 hours per week. This group will be meeting one time per week for twelve weeks, and then one time per month until conception.
Intervention Group will be learning how to lose weight through healthy eating and moderate exercise. The goal is to get participants to lose 7% of body weight and increase physical activity to 2 1/2 hours per week. This group will be meeting one time per week for twelve weeks, and then one time per month until conception.
The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.
The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.
Outcomes
Primary Outcome Measures
Gestational diabetes not present in pregnancy
Secondary Outcome Measures
Full Information
NCT ID
NCT00924599
First Posted
May 4, 2009
Last Updated
July 25, 2016
Sponsor
California Polytechnic State University-San Luis Obispo
1. Study Identification
Unique Protocol Identification Number
NCT00924599
Brief Title
A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women
Official Title
Prevention of Gestational Diabetes Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the feasibility of recruiting and providing a behavioral weight loss program prior to pregnancy to reduce gestational diabetes recurrence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Recurring Gestational Diabetes, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group-English
Arm Type
Experimental
Arm Description
Intervention Group will be learning how to lose weight through healthy eating and moderate exercise. The goal is to get participants to lose 7% of body weight and increase physical activity to 2 1/2 hours per week. This group will be meeting one time per week for twelve weeks, and then one time per month until conception.
Arm Title
Intervention Group-Spanish
Arm Type
Experimental
Arm Description
Intervention Group will be learning how to lose weight through healthy eating and moderate exercise. The goal is to get participants to lose 7% of body weight and increase physical activity to 2 1/2 hours per week. This group will be meeting one time per week for twelve weeks, and then one time per month until conception.
Arm Title
Lifestyle education-English
Arm Type
Active Comparator
Arm Description
The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.
Arm Title
Lifestyle education-Spanish
Arm Type
Active Comparator
Arm Description
The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.
Intervention Type
Behavioral
Intervention Name(s)
Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)
Intervention Description
Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle education (English & Spanish)
Intervention Description
The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.
Primary Outcome Measure Information:
Title
Gestational diabetes not present in pregnancy
Time Frame
from conception to delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
GDM in last pregnancy
BMI 30-40
Age 18-40
1-5 years since last pregnancy
Non-smoking
English or Spanish speaking
Planning to have a baby but willing to use birth control during the 3 month weight loss program
Exclusion Criteria:
3 or more miscarriages
History of infertility
Type 1 or Type 2 diabetes
Any weight loss since last pregnancy (based on last pre-pregnancy weight)
History of major psychiatric illness, drug abuse, or unsafe dieting practices
History of bariatric surgery, major medical conditions that prohibit physical activity or dietary intervention (MD consent may be required)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD.
Organizational Affiliation
California Polytechnic State University-San Luis Obispo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sierra Vista Regional Medical Center
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
12. IPD Sharing Statement
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A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women
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