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

Not Applicable

Completed

• Conditions: Gestational Diabetes
• Interventions: Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish); Behavioral: Lifestyle education (English & Spanish)

• Registration Number: NCT00924599
• Lead Sponsor: California Polytechnic State University-San Luis Obispo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-04
• Study Start: 2009-06
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group-English	Prevention of recurrent gestational diabetes through weight loss and exercise (English & 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.
Intervention Group-Spanish	Prevention of recurrent gestational diabetes through weight loss and exercise (English & 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.
Lifestyle education-Spanish	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.
Lifestyle education-English	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.

Primary Outcome Measures

Name	Time	Method
Gestational diabetes not present in pregnancy	from conception to delivery

Trial Locations

Locations (1)

Sierra Vista Regional Medical Center; 🇺🇸 San Luis Obispo, California, United States