医学的に脆弱なコミュニティにおける慢性疾患のリスクを軽減するための食事、移動、ライブの介入
医学的に脆弱なコミュニティにおけるがんと慢性疾患のリスクを軽減する: イート ムーブ ライブ介入の行動的および生物学的結果を測定する実現可能性調査
This randomized pilot research trial studies how well Eat, Move, Live (EML) works in reducing chronic disease risk in medically vulnerable communities. Obesity, unhealthy diet, and physical inactivity are linked to increased cancer risk, especially hormone-related cancer (example, breast cancer). Improving healthy lifestyle practices, namely increasing physical activity and encouraging healthy eating behaviors may reduce the risk of getting cancer and chronic disease.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
PRIMARY OBJECTIVES:
I. Level of exercise.
II. Reduction in barriers to exercise.
III. Level of self-reported 5-9 servings of fruits and vegetables consumption.
IV. Reduction in barriers to fruit and vegetable consumption.
V. Improvement in biologic/metabolic markers such as hemoglobin A1c, fasting plasma glucose, and body weight.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants complete an assessment on knowledge, attitudes, and behaviors at baseline and attend 2 weekday sessions comprised of interactive education segment that is culturally responsive, and based on the community EML program, and topics including: nutrition guideline, nutrition label reading, comparison shopping/grocery store tour, recipe modification and healthy food preparation, eating healthy on a budget, and making healthy choices outside the home (e.g., restaurants) and physical activity over 1 hour led by Certified Health Educator (CHE), a physical activity conducted by Duarte Fitness Centers instructors over 30 minutes, and cooking/taste test demonstration co-led by the CHE and local chef over 30 minutes over 12 weeks. Participants are also prescribed and encouraged to participate in 3 days a week exercise classes (for > 30 minutes) including salsa, Zumba and other aerobic exercises that are provided at Duarte Fitness Center.
GROUP II: Participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12.
After completion of study, participants are followed up immediately and at 3 months.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Mothers/female guardians of elementary aged students
- Self identify as Latina
- Not adherent to the standard for > five servings of fruits and vegetable and 150 minutes of physical activity
Exclusion Criteria:
- Not a parent of elementary aged student in Duarte Unified School District (DUSD)
- Does not self-identify as Latina
- Does not speak/read/write/understand English/Spanish - Diagnosed with diabetes
- Consumes 5+ servings of fruits and vegetables and is active for at least 30 minutes 5+ days per week
- Has a condition or psychological difficulties that affects day-to-day activities
- Has physical limitations and cannot participate in physical activity
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：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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Group I (EML)
Participants complete an assessment on knowledge, attitudes, and behaviors at baseline and attend 2 weekday sessions comprised of interactive education segment that is culturally responsive, and based on the community EML program, and topics including: nutrition guideline, nutrition label reading, comparison shopping/grocery store tour, recipe modification and healthy food preparation, eating healthy on a budget, and making healthy choices outside the home (e.g., restaurants) and physical activity over 1 hour led by CHE, a physical activity conducted by Duarte Fitness Centers instructors over 30 minutes, and cooking/taste test demonstration co-led by the CHE and local chef over 30 minutes over 12 weeks. Participants are also prescribed and encouraged to participate in 3 days a week exercise classes (for > 30 minutes) including salsa, Zumba and other aerobic exercises that are provided at Duarte Fitness Center. |
Correlative studies Ancillary studies Attend healthy nutritional education session Attend EML educational session
他の名前：
Attend exercise educational session Receive fitness tracker |
|
アクティブコンパレータ：Group II (control)
Participants receive a fitness tracker to track their physical activity and be wait listed to receive the intervention during month 10-12. |
Correlative studies Ancillary studies Attend healthy nutritional education session Attend exercise educational session Receive fitness tracker |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in plasma glucose level measured using point of care glucometer OneTouch Ultra® 2
時間枠：Baseline to up to 3 months
|
Will convert plasma glucose into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures. |
Baseline to up to 3 months
|
|
Changes in hemoglobin A1c level measured using a point of care device A1CNow®
時間枠：Baseline to up to 3 months
|
Will convert hemoglobin A1c into binary outcome variables and evaluate the effect on intervention on these outcomes controlled for significant confounders (age, income, and education will be evaluated for confounding in the logistic regression model). Chi-square goodness of fit tests will compare percent reduction in weight between the control and intervention groups. Chi square tests will be used to determine whether participants reduced weight by 3%. Repeated ANCOVA will be used. Outcome variables will be dichotomized to fit a logistic regression modeling procedures. |
Baseline to up to 3 months
|
|
Changes in level of self reported 5-9 servings of fruits and vegetables using self evaluation and the daily food diary
時間枠：Baseline to up to 3 months
|
Chi-square test and Logistic regression analysis will be used to determine whether the intervention significantly motivated participants to consume 7-8 servings of fruits/vegetables per day, adjusting for significant confounders (e.g., age, baseline BMI). Additionally, the Cochran Q test will be used to evaluate changes on barriers to fruit/vegetable consumption at the baseline and follow-up time points. |
Baseline to up to 3 months
|
|
Changes in reduction in barriers to exercise using self-report evaluation based on historical EML program using Likert-type scale items
時間枠：Baseline to up to 3 months
|
Compliance to exercise at baseline and follow-up will be assessed using Logistic regression analysis. Additionally, the Cochran Q test will be used to evaluate changes on barriers to exercise at the baseline and follow-up time points. |
Baseline to up to 3 months
|
|
Changes in self-reports of activity tracker readings
時間枠：Up to 3 months
|
Will compare baseline and follow-up exercise levels between the intervention and control groups in an independent t-tests, and compare the pre- to post-intervention change in activity tracker readings between groups with repeated measure analysis of covariance with age and baseline body mass index (BMI) as confounders. |
Up to 3 months
|
|
Reduction in barriers to fruit and vegetable consumption using self-evaluation based on historical EML program using Likert-type scale
時間枠：Baseline to up to 3 months
|
Cochran Q test will be used to assess participants' barriers to fruit and vegetable consumption at different follow up period. |
Baseline to up to 3 months
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Kimlin Ashing-Giwa、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (推定)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
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
その他の研究ID番号
- 15160
- 15160 (その他の識別子：City of Hope Medical Center)
- NCI-2015-01220 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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。