Gestational DiabetesNCT04861324
Effects of a Lifestyle Intervention on Gestational Diabetes Management
A study testing Dietary Intervention in people with Gestational Diabetes and Type 2 Diabetes, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Type 2 Diabetes, Nutritional and Metabolic Disease
- What is being tested?
- Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 30 Jan 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- high risk for gestational diabetes
- willing to make lifestyle changes
- history of diabetes
Who cannot join
- carrying more than one fetus
- history of chronic conditions except diabetes and hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
UNLV School of Medicine MFM clinic
Las Vegas, Nevada, 89154
About this study
The purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.
Read the detailed description
Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.
- Being tested
- Dietary Intervention
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity
| Study group | Role | What they receive |
|---|---|---|
| Prenatal Care/Nutrition Education | No intervention | Standard prenatal care with primary care physician with USDA-based federal guidelines |
| Fruit/veggie + postprandial physical activity | Experimental | Nutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery Receives: Behavioral: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal glycemic control
Blood glycated hemoglobin
Measured: 12 weeks
Maternal gestational weight gain
Body weight
Measured: 12 weeks
Maternal medication usage
Glucose-lowering medications
Measured: 12 weeks
Maternal Lipids
LDL-cholesterol and triglycerides
Measured: 12 weeks
Secondary outcomes (2)
Maternal inflammation
Adipokines, C-reactive protein
Measured: 12 weeks
Maternal serum carotenoids
Carotenoids indicating fruit and vegetable consumption
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start28 Apr 2021
- Primary completion31 Dec 2022
- Study completion30 Jan 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arpita Basu, University of Nevada, Las Vegas
- Investigators
- Arpita Basu, PhD, Principal investigator, University of Nevada at Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861324
- Sponsor's protocol ID
- 1610677
- Status last verified
- Feb 2023
- First submitted
- 22 Apr 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Lifestyle Intervention on Gestational Diabetes Management
- ClinicalTrials.gov ID
- NCT04861324
- Acronym / sponsor ID
- 1610677
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 27 Apr 2021 (actual)
- 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 investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.
Detailed description
Diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. Thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. Women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. Blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prenatal Care/Nutrition Education | No intervention | –Standard prenatal care with primary care physician with USDA-based federal guidelines |
| Fruit/veggie + postprandial physical activity | Experimental | Behavioral: Dietary InterventionNutrition education on increasing fruit and vegetable consumption and physical education on increasing postprandial physical activity for the duration from GDM diagnosis till delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- high risk for gestational diabetes
- willing to make lifestyle changes
- history of diabetes
Key exclusion criteria (2 listed)
- carrying more than one fetus
- history of chronic conditions except diabetes and hypertension
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 |
|---|---|---|
| Dietary InterventionIncreasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity | Behavioural | Fruit/veggie + postprandial physical activity |
Primary outcome
Maternal glycemic control
Time frame: 12 weeks
Blood glycated hemoglobin
Maternal gestational weight gain
Time frame: 12 weeks
Body weight
Maternal medication usage
Time frame: 12 weeks
Glucose-lowering medications
Maternal Lipids
Time frame: 12 weeks
LDL-cholesterol and triglycerides
2 secondary outcomes
Maternal inflammation
Time frame: 12 weeks
Maternal serum carotenoids
Time frame: 12 weeks
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 17 Feb 2023.
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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.
Arpita Basu, PhD principal investigator
University of Nevada at Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Gestational Diabetes and Type 2 Diabetes, run by University of Nevada, Las Vegas 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 3 inclusion and 2 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 17 Feb 2023. 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?
Maternal glycemic control (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 17 Feb 2023.