十分なサービスが受けられていない地域社会におけるがんと慢性疾患のリスクを軽減するための、食べて、動いて、暮らすプログラム
十分なサービスが受けられていないコミュニティにおけるがんと慢性疾患のリスクの軽減: 食べて、移動して、暮らすプログラム
This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors.
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To evaluate program by assessing in combination with standard of care metformin: Changes in participants' knowledge, attitudes, and behavior.
II. To evaluate program by assessing in combination with standard of care metformin: Changes in body measurements.
III. To evaluate program by assessing in combination with standard of care metformin: Changes in biomarkers.
OUTLINE:
Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration.
研究の種類
入学 (実際)
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
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:
- Agrees to group consent at week 1
- Age over 18
- Able to speak and understand English and/or Spanish
Exclusion Criteria:
- Don't agree to group consent at week 1
- Age younger than 18
- Not able to speak and understand English and/or Spanish
- Can't 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：支持療法
- 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 |
|---|---|
|
実験的：Supportive care (EML program)
Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration. |
Ancillary studies Attend EML program sessions
他の名前：
|
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 |
|---|---|---|
|
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
時間枠：Baseline and week 12
|
Attitudes and beliefs regarding causes of diabetes asked in questionnaire, measured by endorsing one of the Likert-type scale values ranging from 1 (Agree) to 7 (Disagree). |
Baseline and week 12
|
|
Changes in behavior as measured by questionnaires from baseline to week 12
時間枠：Baseline and week 12
|
Behaviors related to food consumption asked in questionnaires, measured by endorsing one of "None", "1", "2-3", "4-6", "7 or more". |
Baseline and week 12
|
|
Changes in height from baseline to week 12
時間枠：Baseline to 12 weeks
|
Height measured in meters |
Baseline to 12 weeks
|
|
Changes in weight from baseline to week 12
時間枠：Baseline to 12 weeks
|
Weight measured in Kilograms |
Baseline to 12 weeks
|
|
Changes in waist circumference from baseline to week 12
時間枠：Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in chest circumference from baseline to week 12
時間枠：Baseline to 12 weeks
|
Chest circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in right upper arm circumference from baseline to week 12
時間枠：Baseline to 12 weeks
|
Right upper arm circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in left upper arm circumference from baseline to week 12
時間枠：Baseline to 12 weeks
|
Left upper arm circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in right upper thigh circumference from baseline to week 12
時間枠：Baseline to 12 weeks
|
Right upper thigh circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in left upper thigh circumference from baseline to week 12
時間枠：Baseline to 12 weeks
|
Left upper thigh circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in body fat percentage from baseline to week 12
時間枠：Baseline to 12 weeks
|
Body fat percentage measured in percent using a handheld BMI machine that calculates body fat percentage. |
Baseline to 12 weeks
|
|
Changes in systolic blood pressure from baseline to week 12
時間枠：Baseline to 12 weeks
|
Systolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in diastolic blood pressure from baseline to week 12
時間枠：Baseline to 12 weeks
|
Diastolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in hip circumference from baseline to week 12
時間枠：Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in biomarkers
時間枠：Baseline to 12 weeks
|
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines. |
Baseline to 12 weeks
|
協力者と研究者
捜査官
- 主任研究者：Victoria L Seewaldt、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
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
- 17410
- P30CA033572 (米国 NIH グラント/契約)
- 17410 (その他の識別子：City of Hope Comprehensive Cancer Center)
- NCI-2022-00180 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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
米国で製造され、米国から輸出された製品。
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。