健康促進のための夏期青少年雇用プログラム
夏期青少年雇用プログラムを活用した思春期肥満の予防
この概念実証研究の目的は、夏期青少年雇用プログラム(SYEP)が、思春期の肥満に関する未解明の転帰に対して初期の有効性を示すかどうかを評価することです。 この小規模研究は、大規模でより多くのリソースを要するランダム化試験に拡大する前に、早期の成功を特定し介入を改善するために不可欠です。 具体的には、この単一群事前事後テスト研究では以下を行います:
目的1(一次):6週間のSYEPが夏季期間中の有効性の初期兆候(zBMIの維持または減少)を示すかどうかを評価する。
仮説1:SYEPに参加した思春期の若者は、夏季期間中にBMIを維持または減少させる。
目的2(二次):夏季期間中の肥満関連行動(身体活動、睡眠、座位行動、食事)の変化を評価する。
仮説2:SYEPに参加した思春期の若者は、夏季期間中に身体活動を増加させ、座位行動を減少させ、睡眠と食事の質を改善する。
目的3(二次):介入の拡張性を検討するために、肥満予防介入としてのSYEPの実現可能性を評価する。
仮説3:SYEPプログラムは、夏季期間中の思春期の若者の肥満予防に対する実現可能かつ受容可能な介入戦略となる。
調査の概要
詳細な説明
予備的な証拠によると、夏季雇用は、青年期の肥満促進行動における不健康な変化を防ぐための、年齢に適した構造化された介入となり得ることが示唆されています。 これらの知見は有望ですが、既存の研究では夏期におけるBMIの変化を測定したものや、食事、座位行動、睡眠、身体活動を含む肥満促進行動の包括的評価を行ったものはありません。 これらのギャップに対処するため、本研究は、青年期における研究が不十分な肥満関連アウトカムに対する有効性の初期シグナルを評価する小規模な概念実証研究を提案します。
SYEP(夏季青少年雇用プログラム)は、60年以上にわたり確立され継続的に運営されている事業であり、学業、労働力開発、犯罪防止において実証された利点があり、肥満予防戦略としても機能する可能性があります。 新たな介入を創出するのではなく、高い需要があるものの受け入れ枠が限られている(毎年申請者の約28%のみが就労機会を得て、大多数は待機リストに残されている)SYEPプログラムへの投資とアクセス拡大は、青少年肥満予防に対する現実的な解決策を提供し得ます。
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77204
- University of Houston
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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
参加基準:
- テキサス州児童労働法に基づき、登録時点で14歳から17歳であること
- サマーキャンプで6週間連続勤務する意思があること
- 雇用採用手続き(面接)に合格できること
- 研究参加について保護者の同意を得られ、本人の同意が得られること
除外基準:
- 身体活動制限及び研究結果に影響を与え得る体重変動の可能性があるため、現在妊娠中または妊娠を計画している方
- 特別な雇用規定または介入戦略を必要とする知的および/または身体障害の診断を受けている方
- 過去6ヶ月以内に健康増進介入プログラムに参加した方
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:防止
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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:サマーユースエンプロイメントプログラム
参加者は、ヒューストン大学のキャンプでジュニアサマーキャンプカウンセラーとして、6月中旬から7月末までの6週間、月曜日から木曜日までの週24時間まで、午前8時30分から午後3時30分(昼食休憩は午後12時から1時)まで勤務します。
参加者は、ゲーム、教養、学業などの屋内・屋外活動においてシニアカウンセラーを支援します。
金曜日の午前10時から正午までは、参加者はコミュニケーション、チームワーク、履歴書作成、就職活動スキルなどのテーマに関する職業開発ワークショップに参加します。
正午から午後2時30分までは、学部生スタッフが社交活動とメンタリングを主導します。
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この介入は、夏季の6週間にわたり、青少年を有給のポジションで雇用し、学年中と同様の構造化され、ルーティンベースで成人監督のある環境を提供することを目的としています。
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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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Change in Age- and Sex-Specific Body Mass Index (BMI)-For-Age Z-Score (zBMI) From Baseline to Week 6
時間枠:Baseline and Week 6 (post)
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Height and weight will be directly measured by trained staff.
Each measurement will be taken twice, and the average will be used for analysis.
Body mass index (BMI) will be calculated and expressed as Centers for Disease Control and Prevention (CDC) age- and sex-specific BMI-for-age z-scores (zBMI).
The outcome will represent the change in zBMI from baseline to Week 6.
A positive change score will indicate an increase (gain) in zBMI from baseline to Week 6, which will be considered a less favorable outcome.
A negative change score will indicate a decrease in zBMI, which will be considered a favorable outcome.
A change score of 0 will indicate no change in zBMI (maintenance), which will also be considered a favorable outcome for this intervention because preventing excess BMI gain during summer is a primary goal.
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Baseline and Week 6 (post)
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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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Change in Sedentary Behavior From Baseline to Week 6
時間枠:Baseline and Week 6 (post)
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Sedentary behavior will be measured in minutes per day using a wrist-worn ActiGraph GT3X accelerometer on the non-dominant wrist over 8 consecutive days, including at least 2 valid weekdays and 1 valid weekend day.
Activity intensities will be classified using cut points published by Hildebrand et al.
The reported outcome will be the change in average daily sedentary behavior (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in sedentary behavior, which will be considered an unfavorable outcome.
A negative change score will indicate a decrease in sedentary behavior, which will be considered a favorable outcome.
A change score of 0 will indicate no change in sedentary behavior (maintenance).
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Baseline and Week 6 (post)
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Change in Moderate-to-Vigorous Physical Activity (MVPA) From Baseline to Week 6
時間枠:Baseline and Week 6 (post)
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Moderate-to-vigorous physical activity (MVPA) will be measured in minutes per day using a wrist-worn ActiGraph GT3X accelerometer on the non-dominant wrist over 8 consecutive days, including at least 2 valid weekdays and 1 valid weekend day.
Activity intensities will be classified using cut points published by Hildebrand et al.
The reported outcome will be the change in average daily MVPA (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in MVPA, which will be considered a favorable outcome.
A negative change score will indicate a decrease in MVPA, which will be considered an unfavorable outcome.
A change score of 0 will indicate no change in MVPA (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Change in Sleep Duration From Baseline to Week 6
時間枠:Baseline and Week 6 (post)
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Sleep duration will be measured in minutes per day using a wrist-worn ActiGraph GT3X accelerometer on the non-dominant wrist over 8 consecutive days, including at least 2 valid weekdays and 1 valid weekend day.
Sleep duration will be estimated using the heuristic algorithm looking at the distribution of change in Z-Angle (HDCZA).
The reported outcome will be the change in average daily sleep duration (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in sleep duration, which will be considered a favorable outcome.
A negative change score will indicate a decrease in sleep duration, which will be considered an unfavorable outcome.
A change score of 0 will indicate no change in sleep duration (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Change in Screen Time From Baseline to Week 6
時間枠:Baseline and Week 6 (post)
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Screen time in hours and minutes (e.g., television, computer, video games, smart phones, tablets) will assessed via self-report during each 8-day behavioral assessment period.
Screen time will be calculated as the average daily duration (minutes/day) by summing total reported screen time across completed daily logbooks and dividing by the number of valid diary days within each assessment period.
The reported outcome will be the change in average daily screen time (minutes/day) from baseline to Week 6.
A positive change score will indicate an increase in screen time, which will be considered an unfavorable outcome.
A negative change score will indicate a decrease in screen time, which will be considered a favorable outcome.
A change score of 0 will indicate no change in screen time (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Change in Unhealthy Food Intake From Baseline to Week 6
時間枠:Baseline and Week 6 (post)
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Dietary intake will be assessed using the NHANES 23-item Dietary Screener Questionnaire.
Adolescents will self-report consumption of food and beverage items over the past day.
For this outcome, unhealthy food items will include desserts, sugar-sweetened beverages, salty snacks, and fast food items.
Responses will be used to estimate daily intake frequency (times/day) of unhealthy food consumption.
The reported outcome will be the change in average daily frequency of unhealthy food intake (times/day) from baseline to Week 6.
A positive change score will indicate an increase in unhealthy food intake, which will be considered an unfavorable outcome.
A negative change score will indicate a decrease in unhealthy food intake, which will be considered a favorable outcome.
A change score of 0 will indicate no change in unhealthy food intake (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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Recruitment Capacity (Percentage Meeting Recruitment Goal)
時間枠:Baseline
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Recruitment capacity is the percentage meeting the recruitment goal.
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Baseline
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Retention
時間枠:Baseline and Week 6 (post)
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Retention will be calculated as the percentage of enrolled participants who complete both baseline and post-intervention assessments for the primary outcome measures.
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Baseline and Week 6 (post)
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Fidelity
時間枠:Weekly during intervention (Weeks 1-6)
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Fidelity will be assessed through weekly unannounced direct observations using a structured checklist developed by the research team specifically for the intervention.
The checklist will assess key components of intervention implementation, including adherence, dose delivered, quality of delivery, and participant engagement.
Each item will be rated using either binary scoring (0 = not implemented, 1 = implemented) or a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), depending on the construct.
All domain scores will be standardized and converted to a percentage scale.
Each intervention session will be independently rated by two trained researcher, and ratings will be averaged.
Session-level fidelity scores will then be averaged across all observation weeks to produce a single fidelity score.
The fidelity score will be expressed as a percentage, with higher scores indicating greater fidelity to the intervention protocol and lower scores indicating reduced fidelity.
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Weekly during intervention (Weeks 1-6)
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Attendance
時間枠:Weekly during intervention (Weeks 1-6)
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Attendance will be calculated as the average number of days attended across total offered workdays, using employer time sheets.
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Weekly during intervention (Weeks 1-6)
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Acceptability
時間枠:Week 7 (Follow-up)
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Acceptability will be assessed using a quantitative satisfaction measure administered to adolescents following intervention participation.
Participants will be asked to rate their likelihood of returning as a paid counselor the following summer on a scale ranging from 1 (not at all likely) to 10 (extremely likely).
Individual responses will be averaged to generate a single acceptability score.
The total score will range from 1 to 10, with higher scores indicating greater acceptability and willingness to participate again, and lower scores indicating lower acceptability.
Scores closer to 10 will represent high acceptability, while scores closer to 1 will represent low acceptability of the intervention experience.
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Week 7 (Follow-up)
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Change in Healthy Food Intake From Baseline to Week 6
時間枠:Baseline and Week 6 (post)
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Dietary intake will be assessed using the NHANES 23-item Dietary Screener Questionnaire.
Adolescents will self-report consumption of food and beverage items over the past day.
For this outcome, healthy food items will include fruits, vegetables, 100% fruit juice, and milk items.
Responses will be used to estimate daily intake frequency (times/day) of healthy food consumption.
The reported outcome will be the change in average daily frequency of healthy food intake (times/day) from baseline to Week 6.
A positive change score will indicate an increase in healthy food intake, which will be considered a favorable outcome.
A negative change score will indicate a decrease in healthy food intake, which will be considered an unfavorable outcome.
A change score of 0 will indicate no change in healthy food intake (maintenance), which will also be considered a favorable outcome.
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Baseline and Week 6 (post)
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.
- Pierce B, Bowden B, McCullagh M, Diehl A, Chissell Z, Rodriguez R, Berman BM, D Adamo CR. A Summer Health Program for African-American High School Students in Baltimore, Maryland: Community Partnership for Integrative Health. Explore (NY). 2017 May-Jun;13(3):186-197. doi: 10.1016/j.explore.2017.02.002. Epub 2017 Feb 24.
- Yazel-Smith L, El-Mikati HK, Adjei M, Haberlin-Pittz KM, Agnew M, Hannon TS. Integrating Diabetes Prevention Education Among Teenagers Involved in Summer Employment: Encouraging Environments for Health in Adolescence (ENHANCE). J Community Health. 2020 Aug;45(4):856-861. doi: 10.1007/s10900-020-00802-2.
- Modestino AS, Paulsen RJ. Reducing inequality summer by summer: Lessons from an evaluation of the Boston Summer Youth Employment Program. Eval Program Plann. 2019 Feb;72:40-53. doi: 10.1016/j.evalprogplan.2018.09.006. Epub 2018 Sep 24.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
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。