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Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies (HH)

26. juni 2026 opdateret af: Dr. Rebecca Seguin-Fowler, Texas A&M University
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

800

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Texas
      • College Station, Texas, Forenede Stater, 77840
        • Rekruttering
        • Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
        • Kontakt:
        • Ledende efterforsker:
          • Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
        • Ledende efterforsker:
          • Erica Bender, MSN, CNM, NP-Ob/Gyn
      • Dallas, Texas, Forenede Stater, 75252
        • Rekruttering
        • Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
        • Kontakt:
        • Ledende efterforsker:
          • Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
        • Ledende efterforsker:
          • Erica Bender, MSN, CNM, NP-Ob/Gyn
      • Mansfield, Texas, Forenede Stater, 76063
        • Rekruttering
        • Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
        • Ledende efterforsker:
          • Erica Bender, MSN, CNM, NP-Ob/Gyn

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Andet: Food Kit
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
Ingen indgriben: Group 2 (Usual care/control)
Control participants will submit verification that they are receiving or intend to receive standard prenatal care (not study provided).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Healthy Eating Index
Tidsramme: 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).
Baseline to 6 weeks postpartum

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood Concentration of Hemoglobin A1C (HbA1C)
Tidsramme: Baseline to 6 weeks postpartum
Measures average blood sugar levels over the past 2-3 months, acting as a key diagnostic tool for diabetes and prediabetes.
Baseline to 6 weeks postpartum
Gestational weight gain
Tidsramme: Baseline to delivery
Measured in pounds or kilograms. Guidelines suggest 25-35 pounds (lbs) for normal weight, 28-40 lbs for underweight, 15-25 lbs for overweight, and 11-20 lbs for obese individuals.
Baseline to delivery
Blood Concentration of High-Sensitivity C-Reactive Protein (hsCRP)
Tidsramme: Baseline to 6 weeks postpartum
Measures very low levels of C-reactive protein to detect chronic inflammation, primarily assessing cardiovascular disease (CVD) risk.
Baseline to 6 weeks postpartum
Postpartum weight retention
Tidsramme: Baseline to 6 weeks postpartum
Measured in pounds or kilograms at 6 weeks postpartum.
Baseline to 6 weeks postpartum

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Texas A&M University

Samarbejdspartnere

United States Department of Agriculture (USDA)

Efterforskere

  • Ledende efterforsker: Rebecca L Seguin-Fowler, PhD, RDN, LD, CSCS, Texas A&M AgriLife Research
  • Ledende efterforsker: Erica Bender, MSN, CNM, NP-Ob/Gyn, Texas A&M AgriLife Research

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juni 2026

Primær færdiggørelse (Anslået)

31. juli 2028

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-1307
  • 58-3091-2-025 (Andet bevillings-/finansieringsnummer: United States Department of Agriculture- Agricultural Research Service)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified individual participant data, including quantitative and qualitative human health and behavioral data collected via survey, clinical assessment, and related methods, will be made available to qualified researchers upon request. Data will be shared in open, non-proprietary formats (e.g., .csv for tabular data; .txt/.doc for text/qualitative data) accompanied by a file documenting experimental design, data collection methods, software/versions used for processing, variable/column definitions, and units or abbreviations. No personally identifiable information will be shared. Prior to release, datasets will be reviewed for intellectual property, patent, or proprietary constraints. Access will require execution of a data use agreement, approved manuscript proposal plan with statistical analysis details, and approval by the study's data access committee, which will evaluate requests to balance scientific value with participant privacy and the terms of informed consent.

IPD-delingstidsramme

Beginning 24 months following publication of the primary outcome and three key secondary outcome papers and for at least 3 years following project completion.

IPD-delingsadgangskriterier

Requests will be reviewed by the PIs (Seguin-Fowler, Bender, Shankar) and/or designated data access committee. Researchers must submit a written proposal describing the scientific rationale and intended use, and must agree to a data use agreement governing confidentiality, security, and citation requirements. Approved users will receive deidentified data along with a data dictionary and the study protocol. Users are required to cite the dataset in any resulting peer-reviewed publications. Requests and inquiries should be directed to the study PI or designated contact listed in the trial registry record and associated publications.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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