Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies
Recruiting · NCT07659821 · Interventional (participants receive a specific treatment) · Lead sponsor: Texas A&M University
View the official record on ClinicalTrials.gov →Interventions studied
Food Kit
What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
Exclusion criteria
- 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)
Where it is running
3 locations listed across 1 US state.
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture - College Station, Texas, United States
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture - Dallas, Texas, United States
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center - Mansfield, Texas, United States