A Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Suzanne Phelan, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier:
NCT00924599
First received: May 4, 2009
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Gestational Diabetes
Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)
Behavioral: Lifestyle education (English & Spanish)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Gestational Diabetes Pilot Study

Resource links provided by NLM:


Further study details as provided by California Polytechnic State University-San Luis Obispo:

Primary Outcome Measures:
  • Gestational diabetes not present in pregnancy [ Time Frame: from conception to delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group-English
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.
Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)
Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.
Experimental: Intervention Group-Spanish
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.
Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)
Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.
Active Comparator: Lifestyle education-English
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.
Behavioral: Lifestyle education (English & Spanish)
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.
Active Comparator: Lifestyle education-Spanish
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.
Behavioral: Lifestyle education (English & Spanish)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  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: NCT00924599

Locations
United States, California
Sierra Vista Regional Medical Center
San Luis Obispo, California, United States, 93405
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
Investigators
Principal Investigator: Suzanne Phelan, PhD. California Polytechnic State University-San Luis Obispo
  More Information

No publications provided

Responsible Party: Suzanne Phelan, Associate Professor, California Polytechnic State University-San Luis Obispo
ClinicalTrials.gov Identifier: NCT00924599     History of Changes
Other Study ID Numbers: CP-GDPP
Study First Received: May 4, 2009
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by California Polytechnic State University-San Luis Obispo:
Recurring Gestational Diabetes
Prevention

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

ClinicalTrials.gov processed this record on July 31, 2014