Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies (HH)
2026年6月26日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
800
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Erica Bender, MSN, CNM, NP-Ob/Gyn
- 電話番号：979-314-8742
- メール：erica.bender@ag.tamu.edu
研究連絡先のバックアップ
- 名前：Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
- 電話番号：979-845-8486
- メール：r.seguin-fowler@ag.tamu.edu
研究場所
-
-
Texas
-
College Station、Texas、アメリカ、77840
- 募集
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
-
コンタクト：
- Erica Bender, MSN, CNM, NP-Ob/Gyn
- 電話番号：979-314-8742
- メール：erica.bender@ag.tamu.edu
-
主任研究者：
- Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
-
主任研究者：
- Erica Bender, MSN, CNM, NP-Ob/Gyn
-
Dallas、Texas、アメリカ、75252
- 募集
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture
-
コンタクト：
- Erica Bender, MSN, CNM, NP-Ob/Gyn
- 電話番号：979-314-8742
- メール：erica.bender@ag.tamu.edu
-
主任研究者：
- Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
-
主任研究者：
- Erica Bender, MSN, CNM, NP-Ob/Gyn
-
Mansfield、Texas、アメリカ、76063
- 募集
- Texas A&M AgriLife Research Institute for Advancing Health Through Agriculture / Methodist Mansfield Medical Center
-
コンタクト：
- Erica Bender, MSN, CNM, NP-Ob/Gyn
- 電話番号：979-314-8742
- メール：erica.bender@ag.tamu.edu
-
主任研究者：
- Rebecca Seguin-Fowler, PhD, RDN, LD, CSCS
-
主任研究者：
- Erica Bender, MSN, CNM, NP-Ob/Gyn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
Biweekly food kits contain appropriate quantities of whole fruits, vegetables, whole grains, dairy, protein foods and fats.
|
|
介入なし：Group 2 (Usual care/control)
Control participants will submit verification that they are receiving or intend to receive standard prenatal care (not study provided).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Healthy Eating Index
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Concentration of Hemoglobin A1C (HbA1C)
時間枠：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
時間枠：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)
時間枠：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
時間枠：Baseline to 6 weeks postpartum
|
Measured in pounds or kilograms at 6 weeks postpartum.
|
Baseline to 6 weeks postpartum
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Rebecca L Seguin-Fowler, PhD, RDN, LD, CSCS、Texas A&M AgriLife Research
- 主任研究者：Erica Bender, MSN, CNM, NP-Ob/Gyn、Texas A&M AgriLife Research
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月22日
一次修了 (推定)
2028年7月31日
研究の完了 (推定)
2028年7月31日
試験登録日
最初に提出
2026年6月15日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月30日
QC基準を満たした最後の更新が送信されました
2026年6月26日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-1307
- 58-3091-2-025 (その他の助成金/資金番号：United States Department of Agriculture- Agricultural Research Service)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。