Pulse Education and Children
Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:FSU College of Education, Health and Human Services
- 電話番号:850-644-1829
- メール:healthandhumansciences@fsu.edu
研究連絡先のバックアップ
- 名前:Rayven Nairn, MS, RD
- 電話番号:850-644-1829
- メール:rsn25b@fsu.edu
研究場所
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Florida
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Tallahassee、Florida、アメリカ、32306
- 募集
- The Gut Biome Lab
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コンタクト:
- Ravinder Nagpal, PhD
- 電話番号:850-644-1829
- メール:rnagpal@fsu.edu
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副調査官:
- Rayven Nairn, MS, RD
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged 6-13 years old
- Ability to speak English
Exclusion Criteria:
- Frequent pulse consumers (>0.5 cup/week for females and >1 cup / week for males)
- Antibiotic use in the past 3 months
- Diagnosed metabolic/gut diseases (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C > 9%).
- Current use of medications or nutrition supplements
- Individuals following a specific dietary patten
- Individuals who gained or lost >5% body weight within the past 6 months
- Those involved in another study concurrently
- Any allergies to pulses
- Intake of pre/pro/postbiotics in the past 3 months
研究計画
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:基礎科学
- 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 |
|---|---|
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実験的:Education + Pulse Provision Condition
Participants will a six-week pulse education program similar to the education-only group.
However, this group will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions.
In addition to education, families will receive free weekly supply of pulses, pre-measured and packaged according to a stepwise intake plan (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6).
The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research.
Families will be asked to prepare three pulse-based meals per week and complete adherence tracking.
Pulse provisions are scaled to household size to ensure all members meet intake goals.
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Participants will receive the same six-week pulse education program as the EO group.
To further improve success, EP will include individualized dietitian counseling alongside written educational materials, a common strategy in dietary education interventions.
In addition to education, EP families will receive free weekly supply of pulses, pre-measured and packaged according to the same stepwise intake plan.
The pulses provided will include chickpeas, lentils, and black beans, owing to their prebiotic and gut health benefits as identified in previous research.
Families prepare three pulse-based meals per week and complete the same adherence tracking as the EO group.
Pulse provisions are scaled to household size to ensure all members meet intake goals.
The cooking class component will consist of a 4-week family-based cooking series involving both parent(s) and child(ren), with each week focused on a specific pulse: Week 1 (black beans), Week 2 (lentils), Week 3 (black-eyed peas), and Week 4 (chickpeas). Participants will be expected to prepare at least three meals per week using the designated pulse, for a total intake of approximately 1.5 cups per week. On days when pulses are consumed, participants will complete a Pulse Meal Record using a 24-hour dietary recall format to document intake, preparation method, and portion size. Children will also complete a Child Food Experience Survey after each pulse-containing meal; for children aged 6-8 years, parents may read the survey questions aloud as needed. Cooking classes will be administered in separate blocks to ensure that EO and EP participants attend distinct sessions. EO participants will independently review the assigned educational materials before each class. EP participants wi |
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アクティブコンパレータ:Education Only Condition
Participants will receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods.
Families will be asked to prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently.
Adherence is tracked through weekly food logs, checklists, and surveys on child acceptance, meal satisfaction, and preparation feasibility.
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The cooking class component will consist of a 4-week family-based cooking series involving both parent(s) and child(ren), with each week focused on a specific pulse: Week 1 (black beans), Week 2 (lentils), Week 3 (black-eyed peas), and Week 4 (chickpeas). Participants will be expected to prepare at least three meals per week using the designated pulse, for a total intake of approximately 1.5 cups per week. On days when pulses are consumed, participants will complete a Pulse Meal Record using a 24-hour dietary recall format to document intake, preparation method, and portion size. Children will also complete a Child Food Experience Survey after each pulse-containing meal; for children aged 6-8 years, parents may read the survey questions aloud as needed. Cooking classes will be administered in separate blocks to ensure that EO and EP participants attend distinct sessions. EO participants will independently review the assigned educational materials before each class. EP participants wi
Participants receive six weekly pulse-focused nutrition sessions via printed handouts, PPTs, and recipe cards covering pulse nutrition, health benefits, and cooking methods.
Families prepare three pulse-based meals per week following a stepwise intake schedule (0.5 cups in Week 1, 1.0 cup in Week 2, and 1.5 cups from Weeks 3-6) and purchase pulses independently.
One of four pulses (lentils, chickpeas, black eye peas, black beans) will be assigned each week.
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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 |
|---|---|---|
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Adherence to Pulse Intake
時間枠:Baseline to Week 6
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Proportion of participants achieving the prescribed pulse intake of ≥1.5 cups per week, assessed using dietary records and pulse meal logs.
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Baseline to Week 6
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Change in Gut Microbiome Composition and Diversity
時間枠:Baseline to Week 6
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Change in fecal microbiome composition and alpha/beta diversity indices measured by microbiome analysis of stool samples.
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Baseline to Week 6
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Change in Fecal Short-Chain Fatty Acids (SCFA) Concentrations
時間枠:Baseline to Week 6
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Change in fecal concentrations of short-chain fatty acids, including acetate, propionate, and butyrate, measured from stool samples.
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Baseline to Week 6
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Change in Gut Barrier Function Markers
時間枠:Baseline to Week 6
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Change in biomarkers of intestinal epithelial/barrier function measured in biological samples.
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Baseline to Week 6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sustainability of Pulse Intake
時間枠:Week 12 Follow-Up
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Maintenance of pulse consumption following completion of the intervention, assessed by dietary records and pulse intake questionnaires.
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Week 12 Follow-Up
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Change in Blood Lipid Profile
時間枠:Baseline to Week 6
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Change in serum lipid concentrations, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
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Baseline to Week 6
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Change in Fasting Blood Glucose
時間枠:Baseline to Week 6
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Change in fasting blood glucose concentration measured from blood samples.
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Baseline to Week 6
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Change in Blood Metabolomic Profile
時間枠:Baseline to Week 6
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Change in circulating metabolomic signatures associated with pulse consumption and metabolic health.
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Baseline to Week 6
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Change in Gut Transit Time
時間枠:Baseline to Week 6
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Evaluate changes in gut transit time after pulse consumption for 6 weeks from baseline to final analysis, using a blue-dye capsule.
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Baseline to Week 6
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Change in Inflammatory Biomarkers
時間枠:Baseline to Week 6
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Change in circulating and/or fecal biomarkers of inflammation.
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Baseline to Week 6
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Change in Gastrointestinal Tolerance Symptoms
時間枠:Baseline to Week 6
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Evaluate changes in gastrointestinal tolerance symptoms to pulses like bloating, gas, and/or stomach cramping using a post-meal survey.
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Baseline to Week 6
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Gastrointestinal Symptoms
時間枠:Baseline to Week 6
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Frequency and severity of gastrointestinal symptoms, including bloating, abdominal discomfort, gas, diarrhea, and constipation, reported during the intervention period.
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Baseline to Week 6
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Incidence of Adverse Events Related to Pulse Consumption
時間枠:Baseline to Week 6
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Number and severity of adverse events judged to be related to study participation or pulse consumption.
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Baseline to Week 6
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Ravinder Nagpal, PhD、Florida State University
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00006859
- 58-3060-5-080 (その他の助成金/資金番号:USDA ARS)
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?
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
米国FDA規制機器製品の研究
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