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

Gestational Diabetes Clinical Trial

Official title:

Prevention of Gestational Diabetes Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924599
• Other study ID #: CP-GDPP
• Status: Completed
• Phase: N/A
• First received: May 4, 2009
• Last updated: July 25, 2016
• Start date: June 2009
• Est. completion date: June 2014

Study information

• Verified date: July 2016
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sierra Vista Regional Medical Center	San Luis Obispo	California

Sponsors (1)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational diabetes not present in pregnancy		from conception to delivery	No