A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women
Prevention of Gestational Diabetes Pilot Study
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 26, 2016
July 1, 2016
5 years
May 4, 2009
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gestational diabetes not present in pregnancy
from conception to delivery
Study Arms (4)
Intervention Group-English
EXPERIMENTALIntervention 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
EXPERIMENTALIntervention 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-English
ACTIVE COMPARATORThe 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
ACTIVE COMPARATORThe 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
Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.
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.
Eligibility Criteria
You may qualify if:
- GDM in last pregnancy
- BMI 30-40
- Age 18-40
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sierra Vista Regional Medical Center
San Luis Obispo, California, 93405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Phelan, PhD.
California Polytechnic State University-San Luis Obispo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 4, 2009
First Posted
June 19, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
July 26, 2016
Record last verified: 2016-07