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燃料: 小学生の子供の健康的な食事と成長のための食べ物、楽しさ、新鮮さ、家族。 (FUEL)

2026年9月17日 更新者:Maninder Kahlon、University of Texas at Austin

燃料: 食べ物、楽しさ、新鮮さ、家族向けプログラム。放課後プログラムと家族サポートを通じて子どもたちの食生活を改善する。

The goal of this community-based randomized trial in elementary-aged children and a caregiver (parent/guardian) is to test the effect of providing families with produce and grocery store gift cards (family support) in conjunction with an after-school program for physical activity and healthy eating on improving children's overall diet, in comparison to the child only attending the after-school program without the family support.

Participating families will:

  • receive weekly produce bags delivered to their home, recipes, and gift cards to a local grocery store (family support)
  • the child will attend the after-school program during the school year

Researchers will compare the child's diet and eating scores with those in the after-school program alone.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Children in grades 1 to 5 and enrolled in after-school program offered by the Boys & Girls Clubs of Austin Area (BGCAA) in selected schools, together with their caregiver (a parent/guardian), will be randomized into one of the two arms:

  • Intervention group will receive, for 4 wks, 10 lbs of produce delivered weekly at home and one USD 20 gift card sent bi-weekly (total USD 40). Then, for 15 wks, the caregiver will receive every other week an electronic interactive health goals reminder survey to complete, for which they receive USD10 if completed. The goal sheets are optional activities.
  • Control group will receive $120 as grocery store e-gift cards at the end of the study.

Regardless of the allocation arm, the child will attend the BGCAA's afterschool program as part of their family's association with the organization. The program runs daily, and the children are encouraged to attend at least 2x/wk. The "Coordinated Approach to Child Health" (CATCH) program will be delivered as part of the BGCAA program 2x/week.

Primary question: Does a 19-week after-school evidence-based program on nutrition education and physical activity for elementary-aged children improve overall child diet better when resources to encourage healthy eating are also provided to caregivers than when such resources are not provided?

研究の種類

介入

入学 (実際)

119

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。

研究場所

    • Texas
      • Austin、Texas、アメリカ、78723
        • Boys & Girls Clubs of Austin

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

5年~11年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Index guardian must be at least 18 years old
  • Child must be enrolled in grade 1 to 5 (aged approx. 6-11 y-o) for the 2023-2024 school year
  • Child must be enrolled in the BGCAA after-school program at the beginning of the 2023-24 fall semester at one of the 11 sites where BGCAA offers after-school program to elementary school-aged children
  • Index parent must be able to speak English and/or Spanish

Exclusion Criteria:

  • Already having a sibling enrolled in the study
  • Child having serious food allergies or dietary restrictions associated with produce products

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:ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的:介入: 放課後プログラム + 家族サポート
  • Family tip sheets sent via mobile text at the start of the program and then every 3 weeks, to a total of 6 mobile text messages

  • Weeks 1-4 (4 weeks):

    i. Welcome package mailed in the first week of the program ii. Weekly: one 10-lbs box of produce iii. Recipes accompanying each box (sample recipe card attached to submission) iv. Bi-Weekly: Grocery store gift cards (2x USD 20, to a total of USD 40)

  • Weeks 5-19 (total of 10 weeks over the 19-week study timeline):

    i. An optional online form ("goal sheet") is sent to the parent/caregiver every other week (total 5) with questions about trying new FV items to be submitted in the next 7 days. As an incentive, a USD 10 gift card is sent to those who complete it (a potential total of USD 50).

ii. Week 11: an extra USD 20 gift card in the week after a school holiday to re-engage participants due to the school-year break.

  1. The whole BGCAA's after-school program runs for 3h, Mon-Fri for the school year across all sites where the organization offers the program. All children enrolled are expected to attend a minimum of 2x/week.
  2. In the BGCAA's after-school program, children participate in active recreational time (approx. 60 min, offered 1x/week at a minimum) which is a mixture of free play, structured physical activity games, and/or sports activities (including soccer, football, and basketball).
  3. Uniquely to sites participating in the study, BGCAA's staff will deliver selected CATCH (Coordinated Approach to Child Health) curriculum components in blocks of 45-60 min, 2x/week, as part of the after-school program. The curriculum will focus on healthy eating education and physical activity designed for elementary school-aged children. More information on CATCH at https://catch.org/ (accessed 8/11/2023)
アクティブコンパレータ:コントロール: 放課後プログラムのみ
  1. The whole BGCAA's after-school program runs for 3h, Mon-Fri for the school year across all sites where the organization offers the program. All children enrolled are expected to attend a minimum of 2x/week.
  2. In the BGCAA's after-school program, children participate in active recreational time (approx. 60 min, offered 1x/week at a minimum) which is a mixture of free play, structured physical activity games, and/or sports activities (including soccer, football, and basketball).
  3. Uniquely to sites participating in the study, BGCAA's staff will deliver selected CATCH (Coordinated Approach to Child Health) curriculum components in blocks of 45-60 min, 2x/week, as part of the after-school program. The curriculum will focus on healthy eating education and physical activity designed for elementary school-aged children. More information on CATCH at https://catch.org/ (accessed 8/11/2023)

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
Child's fruit and vegetable intake as measured by the Texas School Physical Activity and Nutrition (TX SPAN) 2019-2020 dietary assessment questions
時間枠:Baseline, mid-point (4 weeks), end-point (19 weeks)

This study will use the section of the TX SPAN data collection instrument related to food choices via structured interview (English or Spanish). 32 questions reference specific marker foods or food groups asking the number of times each food group was consumed on the previous day (analogous to a 24h recall), with responses 0 times, 1 time, 2 times or 3 or more times. Total FV variety will be measured by summing the items that ask about fruit and vegetable varieties (excluding juice).

More on the TX SPAN can be found at <go.uth.edu/SPAN>.

Baseline, mid-point (4 weeks), end-point (19 weeks)
Child's overall diet quality as assessed by SPAN Healthy Eating Index (SHEI)
時間枠:Baseline, mid-point (4 weeks), end-point (19 weeks)

As described in 2015 Ranjit et al. SPAN Healthy Eating Index (SHEI) is a composite measure comprising both healthy and unhealthy items from diet measures available in the TX SPAN.

Healthy score is the sum of previous day consumption of baked or grilled (not fried) meats, milk, yogurt, brown rice, brown pasta, a variety of vegetable types, fruits (not fruit juice), and beans.

Unhealthy score is the sum of consumption of fried meat, red meat, sugar-sweetened beverages, salty fried snacks, and a variety of dessert items. These are reverse coded, so that the lowest frequency represented the healthiest eating practice.

These two sums are combined into the single composite SHEI and rescaled from 0-100, where higher scores mean healthier eating practices.

Baseline, mid-point (4 weeks), end-point (19 weeks)

二次結果の測定

結果測定
メジャーの説明
時間枠
Guardian's fruits and vegetables intake as measured by the NHANES 2009-2010 Dietary Screening Questionnaire (DSQ)
時間枠:Baseline, mid-point (4 weeks), end-point (19 weeks)

The DSQ FV module has 10 items that capture frequency of consumption of fruits and vegetables and their sources (such as vegetables in recipes) in the past 30 days. It does not require participants to report serving size. Responses are converted to daily cup equivalent estimates.

Baseline, mid-point (4 weeks), end-point (19 weeks)
BMI-for-age percentile
時間枠:Baseline, end-point (19 weeks)

Twice during the program, all children in the after-school program will participate in an interactive activity during a field day where BGCAA staff (blinded to the study arm allocation) measures the children's weight, height and how high they can jump. Because body weight may be a sensitive issue to some children and/or their families, it was proposed to embed it in the daily after-school activities, minimizing the focus on direct and open measurement of weight.

First, height will be measured using a stadiometer against the wall before the activity. Then, the child will stand on a mat with an integrated scale that will measure their weight. Finally, the children will write their name on an athletic tape and/or post-it notes and jump to stick it to a wall.

Baseline, end-point (19 weeks)

その他の成果指標

結果測定
メジャーの説明
時間枠
Guardian's mental health as assessed by the Mental Component Score (MCS-12) of the Short-Form 12 Health Survey version 1 (SF-12v1)
時間枠:Baseline, end-point (19 weeks)

Self-reported measure assessing the impact of health on an individual's everyday life, often used as a quality of life measure. Two summary scores are reported: 1) a mental component score (MCS-12) and 2) a physical component score (PCS-12). The United States population average PCS-12 is 50 points with standard deviation of 10 points.

Baseline, end-point (19 weeks)
Child's mental health status as measured by the Strengths & Difficulties Questionnaire (SDQ)
時間枠:Baseline, mid-point (4 weeks), end-point (19 weeks)

SDQ is a brief psychological assessment and behavioral screening tool for 2-17 year-olds (Goodman, 1997), reported by their parents/guardians in the study. 25 items are divided between 5 scales: 1) emotional symptoms (5 items); 2) conduct problems (5 items); 3) hyperactivity/inattention (5 items); 4) peer relationship problems (5 items); 5) prosocial behavior (5 items), with the timeframe of past 6 months. Scores in the sections 1 to 4 are added to generate a total difficulties score (20 items). Higher scores indicate greater difficulties (poorer mental health status).

Baseline, mid-point (4 weeks), end-point (19 weeks)
Child's physical activity engagement as measured by the physical activity questions in the Texas School Physical Activity and Nutrition (TX SPAN) 2nd grade 2019-2020
時間枠:Baseline, end-point (19 weeks)

Questions are posed to the guardian. Two items assess 1) how many days in the past week the child was physically active for at least 60 min. and 2) played outdoors for at least 30 min. outside of school hours. The other 5 items assess attitude and usual engagement in physical activity. The demographics survey at baseline will ask whether the child has limited physical ability to engage in activities.

Baseline, end-point (19 weeks)

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

協力者

捜査官

  • 主任研究者:Maninder Kahlon, PhD、University of Texas at Austin

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)

2023年9月6日

一次修了 (実際)

2024年3月13日

研究の完了 (実際)

2024年3月20日

試験登録日

最初に提出

2023年8月18日

QC基準を満たした最初の提出物

2023年8月18日

最初の投稿 (実際)

2023年8月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月21日

QC基準を満たした最後の更新が送信されました

2026年9月17日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • STUDY00004545

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?

いいえ

IPD プランの説明

By request

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。