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

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Gestational Diabetes Pilot Study

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)
* Behavioral: Lifestyle education (English & Spanish)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group-English<br>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)<br>* Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.<br>|
| Experimental: Intervention Group-Spanish<br>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)<br>* Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.<br>|
| Active Comparator: Lifestyle education-English<br>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)<br>* 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.<br>|
| Active Comparator: Lifestyle education-Spanish<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurring Gestational Diabetes, Prevention