Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 3
- 主要终点
- Healthy Eating Index
研究概览
简要总结
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.
详细描述
The goal of this clinical trial is to examine the effects of a personalized food kit on diet quality and pregnancy outcomes in pregnant women. The main questions it aims to answer are:
- Does receiving the food kit improve the quality of a mother's diet and specified pregnancy outcomes, compared to standard prenatal care?
- Researchers will compare participants who receive the Harvesting Health Food Kit (intervention group) with those who do not; all participants submit verification that they are receiving or intend to receive standard prenatal care. From an implementation evaluation perspective the study will address logistical issues (frequency, ease of use and utilization) of a personalized food kit in pregnancy.
Participants will:
- Be randomly assigned to either receive the food kit or not (all participants submit verification that they are receiving or intend to receive standard prenatal care, which is not provided by the study).
- Attend regular study visits for clinical data collection and complete questionnaires about their diet and health.
- (Intervention group only) Order and receive and a food kit that can be updated and personalized every two weeks within designated food categories and amounts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Group 2 (Usual care/control)
Control participants will submit verification that they are receiving or intend to receive standard prenatal care (not study provided).
Group 1 (Harvesting Health Food Kit Intervention)
For the intervention group, participation in the food kit (distributed every 2 weeks) will begin in the 1st trimester and end with 2-3 kits postpartum (last kit at 6 weeks). Final data collection is scheduled at/around 12 weeks postpartum. Participants choose all of their food kit contents within specified categories and amounts. Participants will also submit verification that they are receiving or intend to receive standard prenatal care (not study provided).
干预措施: Food Kit (Other)
结局指标
主要结局
Healthy Eating Index
时间窗: Baseline to 6 weeks postpartum
Ranging from 0 to 100, a higher Healthy Eating Index {HEI) score indicates a diet rich in healthy components (fruits, vegetables, whole grains) and lower in moderation components (sodium, added sugars, saturated fats). Calculated from 24-hour recalls collected via Nutrition Data System for Research (NDSR).
次要结局
- Gestational weight gain(Baseline to delivery)
- Blood Concentration of High-Sensitivity C-Reactive Protein (hsCRP)(Baseline to 6 weeks postpartum)
- Postpartum weight retention(Baseline to 6 weeks postpartum)
研究者
Dr. Rebecca Seguin-Fowler
Associate Director Institute for Advancing Health through Agriculture
Texas A&M University