Gestational Diabetes MellitusNCT02763150
Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women
A study testing Lifestyle intervention and Health Promotion in people with Gestational Diabetes Mellitus, run by California Polytechnic State University-San Luis Obispo at 2 sites in United States.
Trial summary
The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Lifestyle intervention and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2017to 29 Jul 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Prior diagnosis of gestational diabetes.
- BMI > 25 kg/m2
- Planning to have a baby in the next 1-3 years
- English or Spanish speaking
Who cannot join
- Age less than 18 years
- Women with Type 2 or Type 1 diabetes
- Current pregnancy
- Relocating in the next 2 years
- Medications that affect weight/diabetes
- Serious current physical disease
Show all 10Show fewer
- History of eating disorders
- History of bariatric surgery
- Current problems with drug abuse
- Current treatment of a serious psychological disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Miriam Hospital
Providence, Rhode Island, 02906
California Polytechnic State University
San Luis Obispo, California, 93401
About this study
Official title: Gestational Diabetes Prevention Program
The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Lifestyle intervention, Health Promotion
- Keywords
- 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.
Lifestyle interventionBehavioural
Intervention group will receive comprehensive behavioral weight loss program.
Health PromotionOther
The health promotion group will receive education on healthy eating and activity
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies. Receives: Behavioral: Lifestyle intervention |
| Health Promotion | Active comparator | Health promotion group will receive education on healthy eating and activity before pregnancy. Receives: Other: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Gestational Diabetes Mellitus
Measured: 26 weeks gestation
Secondary outcomes (9)
Changes in maternal levels of fasting glucose
Measured: study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of fasting insulin
Measured: study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of systolic and diastolic blood pressure
Measured: study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of C-reactive protein
Measured: study entry, 16 weeks, 26 weeks gestation
Incidence of preeclampsia
Measured: Delivery
Incidence of cesarean delivery
Measured: Delivery
Weight changes
Measured: study entry, 16 weeks, 26 weeks gestation
Daily caloric intake
Measured: study entry, 16 weeks, 26 weeks gestation
Minutes per week of moderate physical activity
Measured: study entry, 16 weeks, 26 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start15 Dec 2017
- Primary completion15 Apr 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Polytechnic State University-San Luis Obispo
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- 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
- NCT02763150
- Sponsor's protocol ID
- CP-GDPP-trial
- Status last verified
- Jul 2022
- First submitted
- 29 Apr 2016
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be made available to outside investigators after the primary and secondary analyses are completed and in accordance with local institutional review board and NIH policies.
Publications
Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Aug;229(2):158.e1-158.e14. doi: 10.1016/j.ajog.2023.01.037. Epub 2023 Feb 8.
PubMed 36758710Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevencion de la Diabetes Gestacional. Trials. 2021 Apr 7;22(1):256. doi: 10.1186/s13063-021-05204-w.
PubMed 33827659
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT02763150
- Acronym / sponsor ID
- CP-GDPP-trial
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational Diabetes Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- California Polytechnic State University-San Luis ObispoUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 5 May 2016 (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 overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle interventionIntervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies. |
| Health Promotion | Active comparator | Other: Health PromotionHealth promotion group will receive education on healthy eating and activity before pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior diagnosis of gestational diabetes.
- BMI > 25 kg/m2
- Planning to have a baby in the next 1-3 years
- English or Spanish speaking
Key exclusion criteria (10 listed)
- Age less than 18 years
- Women with Type 2 or Type 1 diabetes
- Current pregnancy
- Relocating in the next 2 years
- Medications that affect weight/diabetes
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 |
|---|---|---|
| Lifestyle interventionIntervention group will receive comprehensive behavioral weight loss program. | Behavioural | Lifestyle Intervention |
| Health PromotionThe health promotion group will receive education on healthy eating and activity | Other | Health Promotion |
Primary outcome
Incidence of Gestational Diabetes Mellitus
Time frame: 26 weeks gestation
9 secondary outcomes
Changes in maternal levels of fasting glucose
Time frame: study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of fasting insulin
Time frame: study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of systolic and diastolic blood pressure
Time frame: study entry, 16 weeks, 26 weeks gestation
Changes in maternal levels of C-reactive protein
Time frame: study entry, 16 weeks, 26 weeks gestation
Incidence of preeclampsia
Time frame: Delivery
Incidence of cesarean delivery
Time frame: Delivery
Weight changes
Time frame: study entry, 16 weeks, 26 weeks gestation
Daily caloric intake
Time frame: study entry, 16 weeks, 26 weeks gestation
Minutes per week of moderate physical activity
Time frame: study entry, 16 weeks, 26 weeks gestation
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 2 Aug 2022.
- Derived from this study: PubMed 36758710Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Randomized controlled trial of prepregnancy lifestyle intervention to reduce recurrence of gestational diabetes mellitus. Am J Obstet Gynecol. 2023 Aug;229(2):158.e1-158.e14. doi: 10.1016/j.ajog.2023.01.037. Epub 2023 Feb 8.
- Derived from this study: PubMed 33827659Phelan S, Jelalian E, Coustan D, Caughey AB, Castorino K, Hagobian T, Munoz-Christian K, Schaffner A, Shields L, Heaney C, McHugh A, Wing RR. Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevencion de la Diabetes Gestacional. Trials. 2021 Apr 7;22(1):256. doi: 10.1186/s13063-021-05204-w.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be made available to outside investigators after the primary and secondary analyses are completed and in accordance with local institutional review board and NIH policies.
Related trials for Gestational Diabetes Mellitus
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
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STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention and Health Promotion in people with Gestational Diabetes Mellitus, run by California Polytechnic State University-San Luis Obispo at 2 sites 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 4 inclusion and 10 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 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence of Gestational Diabetes Mellitus (time frame: 26 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02763150, which also lists 2 linked publications.
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 2 Aug 2022.