Gestational DiabetesNCT00924599
A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women
A study testing Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish) and Lifestyle education (English & Spanish) in people with Gestational Diabetes, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish) and Lifestyle education (English & Spanish)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Sierra Vista Regional Medical Center
San Luis Obispo, California, 93405
About this study
Official title: 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.
- Conditions
- Gestational Diabetes
- Being tested
- Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish), Lifestyle education (English & Spanish)
- Keywords
- Recurring Gestational Diabetes, Prevention
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish)Behavioural
Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.
Lifestyle education (English & Spanish)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group-English | Experimental | 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. Receives: Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish) |
| Intervention Group-Spanish | Experimental | 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. Receives: Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish) |
| Lifestyle education-English | Active comparator | 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. Receives: Behavioral: Lifestyle education (English & Spanish) |
| Lifestyle education-Spanish | Active comparator | 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. Receives: Behavioral: Lifestyle education (English & Spanish) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational diabetes not present in pregnancy
Measured: from conception to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Phelan, California Polytechnic State University-San Luis Obispo
- Investigators
- Suzanne Phelan, PhD., Principal investigator, California Polytechnic State University-San Luis Obispo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924599
- Sponsor's protocol ID
- CP-GDPP
- Status last verified
- Jul 2016
- First submitted
- 4 May 2009
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Gestational Diabetes Pilot Study
- ClinicalTrials.gov ID
- NCT00924599
- Acronym / sponsor ID
- CP-GDPP
- Conditions
- Gestational Diabetes
- Keywords
- Recurring Gestational Diabetes, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Group-English | Experimental | Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & 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. |
| Intervention Group-Spanish | Experimental | Behavioral: Prevention of recurrent gestational diabetes through weight loss and exercise (English & 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. |
| Lifestyle education-English | Active comparator | 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. |
| Lifestyle education-Spanish | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- GDM in last pregnancy
- BMI 30-40
- Age 18-40
- 1-5 years since last pregnancy
- Non-smoking
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group-English, Intervention Group-Spanish |
| 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. | Behavioural | Lifestyle education-English, Lifestyle education-Spanish |
Primary outcome
Gestational diabetes not present in pregnancy
Time frame: from conception to delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Phelan, PhD. principal investigator
California Polytechnic State University-San Luis Obispo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish) and Lifestyle education (English & Spanish) in people with Gestational Diabetes, run by California Polytechnic State University-San Luis Obispo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational diabetes not present in pregnancy (time frame: from conception to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.