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

California Polytechnic State University (Cal Poly)

Status: Completed

Conditions: Gestational Diabetes

Treatments: Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish); Behavioral: Lifestyle education (English & Spanish)

Study type: Interventional

Funder types: Other

Identifiers

NCT00924599

CP-GDPP

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Intervention Group-English

Experimental group

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.

Treatment:

Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)

Intervention Group-Spanish

Experimental group

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.

Treatment:

Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)

Lifestyle education-English

Active Comparator group

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.

Treatment:

Behavioral: Lifestyle education (English & Spanish)

Lifestyle education-Spanish

Active Comparator group

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.

Treatment:

Behavioral: Lifestyle education (English & Spanish)