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

NCT ID: NCT00924599

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-06-30

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.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.

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.

Group Type ACTIVE_COMPARATOR

Lifestyle education (English & Spanish)

Intervention Type BEHAVIORAL

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-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.

Group Type ACTIVE_COMPARATOR

Lifestyle education (English & Spanish)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Phelan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Phelan, PhD.

Role: PRINCIPAL_INVESTIGATOR

California Polytechnic State University-San Luis Obispo

Locations

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Sierra Vista Regional Medical Center

San Luis Obispo, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-GDPP

Identifier Type: -

Identifier Source: org_study_id

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