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

Prevention of Gestational Diabetes Pilot Study

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93405
      • Sierra Vista Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gestational diabetes not present in pregnancy	from conception to delivery

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 4, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (Estimate): June 19, 2009

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Prevention; Recurring Gestational Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: CP-GDPP