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New treatment option for Pregnant Women With Singleton Pregnancies
Official title Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies
ClinicalTrials.gov ID: NCT07659821
What this study is testing
- What it's testing
- This is a randomized controlled trial to assess whether a personalized food kit to pregnant women is feasible, improves diet quality, and enhances pregnancy and birth outcomes compared to standard prenatal care.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant individuals 7-12 weeks of gestation at the time of enrollment
- Aged 18-45 years
- Carrying a singleton pregnancy
- Able to read and speak in English or Spanish
- Reside and plan to receive prenatal and postpartum care within the Dallas-Fort Worth (DFW) metropolitan area or College Station area.
You likely can't join if
- Diagnosis of pre-existing type 1 diabetes
- Significant chronic medical conditions that might impact pregnancy outcomes or study participation (e.g., severe hypertension, renal disease)
- Multiple gestation
- Fetal anomaly
- History of bariatric surgery or other conditions that affect nutrient absorption
- Current eating disorder
See the full eligibility criteria
- Pregnant individuals 7-12 weeks of gestation at the time of enrollment
- Aged 18-45 years
- Carrying a singleton pregnancy
- Able to read and speak in English or Spanish
- Reside and plan to receive prenatal and postpartum care within the Dallas-Fort Worth (DFW) metropolitan area or College Station area.
- Willing to travel to Collin, Dallas, Denton, Ellis, Kaufman, Rockwall, or Tarrant counties for in-person data collection visits
- Willing to receive the food kit from local partners through delivery or in-person pick-up, as applicable
- Verification of established or planned prenatal care with a prenatal healthcare provider
- Access to a smartphone
- Willing and able to provide informed consent
- Diagnosis of pre-existing type 1 diabetes
- Significant chronic medical conditions that might impact pregnancy outcomes or study participation (e.g., severe hypertension, renal disease)
- Multiple gestation
- Fetal anomaly
- History of bariatric surgery or other conditions that affect nutrient absorption
- Current eating disorder
- Current use of exclusionary medications (i.e., systemic steroids or anti-seizure medications)
- Continued use of weight loss medication
- Substance use disorder
- Current or planned enrollment in another intervention study of any type
- Inability to comply with study procedures (e.g., cognitive impairment, plan to move away before study completion, loss of pregnancy)
The study team makes the final eligibility decision.
Where it's taking place
- College Station, Texas, United States
- Dallas, Texas, United States
- Mansfield, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include College Station, Texas, United States; Dallas, Texas, United States; Mansfield, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.